Accepted Manuscript

Title: Self-management program for chronic low back pain: A

systematic review and meta-analysis

Authors: Shizheng Du RN, Master in Nursing Lecturer Lingli

Hu Bachelor in Clinical Medicine Jianshu Dong Master in
Psychology Guihua Xu RN, Ph.D Professor Xuan Chen RN,
Ph.D Professor Shengji Jin RN, Ph.D Lecturer Heng Zhang
RN, Ph.D Lecturer Haiyan Yin RN, Master in Nursing
Lecturer

PII: S0738-3991(16)30324-X
DOI: http://dx.doi.org/doi:10.1016/j.pec.2016.07.029
Reference: PEC 5410

To appear in: Patient Education and Counseling

Received date: 21-3-2016

Revised date: 20-7-2016
Accepted date: 21-7-2016

Please cite this article as: Du Shizheng, Hu Lingli, Dong Jianshu, Xu Guihua, Chen
Xuan, Jin Shengji, Zhang Heng, Yin Haiyan.Self-management program for chronic low
back pain: A systematic review and meta-analysis.Patient Education and Counseling
http://dx.doi.org/10.1016/j.pec.2016.07.029

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Self-Management Program for Chronic Low Back Pain: A Systematic

Review and Meta-Analysis

Shizheng Dua, Lingli Hub, Jianshu Dongc, Guihua Xu*a, Xuan Chena, Shengji

Jina, Heng Zhanga, Haiyan Yina

Author affiliations:

a
School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China

(Address: 138 Xianlin Avenue, Qixia District, Nanjing, Jiangsu Province,

China; ZIP code: 210023 )

b
Department of Nuclear Medicine, Nanjing Drum Tower Hospital, the Affiliated

Hospital of Nanjing University Medical School, Nanjing, China (Address: 321

Zhongshan Road, Gulou District, Nanjing, Jiangsu Province, China; ZIP

code: 210008)

c
Shanghai Health Education Institute, Shanghai, China (Address:

358Jiaozhou Road Building B, Jing’an District, Shanghai, China; ZIP code:

200040)

*Corresponding author，Address: Prof. Guihua Xu, School of Nursing, Nanjing

University of Chinese Medicine, 138 Xianlin Avenue, Qixia District, Nanjing，

Jiangsu Province, 210023, China. Tel & Fax: +86-25-85811648; E-mail:

xgh_88@126.com.

-1-
Shizheng Du: RN; Lecturer; Master in Nursing;

Lingli Hu: Bachelor in Clinical Medicine;

Jianshu Dong: Master in Psychology;

Guihua Xu: RN; Professor, Ph.D; Corresponding author;

Xuan Chen: RN; Professor, Ph.D;

Shengji Jin: RN; Lecturer, Ph.D;

Heng Zhang: RN; Lecturer, Ph.D;

Haiyan Yin: RN; Lecturer; Master in Nursing.

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 Trials are searched on self-management program for chronic low back pain.

 Thirteen randomized controlled trials with fair quality are included.

 Self-management program is effective in chronic low back pain management.

 No adverse events are reported.

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Objective: To determine the effectiveness of self-management programs

(SMPs) on chronic low back pain (CLBP).

Methods: A search of randomized controlled trials (RCTs) was performed in

Pubmed, Cochrane Library, Web of Science, Elsevier, and CINAHL through

June, 2015. Two reviewers selected trials, conducted critical appraisal, and

extracted data. Meta analyses were performed.

Results: Thirteen moderate-quality RCTs were included. There were 9 RCTs

for immediate post intervention on pain intensity and disability, 5 RCTs for short

term, 3 RCTs for intermediate and 4 RCTs for long term. Specifically, the effect

sizes (ESs) of SMP on pain intensity were -0.29, -0.20, -0.23, and -0.25 at

immediate post-intervention, short-term, intermediate-term, and long-term

follow-ups, respectively. The ESs on disability were -0.28, -0.23, -0.19, and

-0.19 at immediate post-intervention, short-term, intermediate-term, and

long-term follow-ups, respectively.

Conclusion: For CLBP patients, there is moderate-quality evidence that SMP

has a moderate effect on pain intensity, and small to moderate effect on

disability.

Practice implications：SMP can be regarded as an effective approach for

CLBP management. In addition to face-to-face mode, internet-based strategy

can also be considered as a useful option to deliver SMP. Theoretically driven

programs are preferred.

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Key words: Low back pain, chronic; Self-management program; Systematic

review; Meta analysis

-5-
1. Introduction

1.1. Definition and prevalence of chronic low back pain

Chronic low back pain (CLBP) is considered as a world-wide concern, and

many strategies have been explored. Low back pain (LBP) is defined as “pain

occurring in the lumbosacral region with radiation limited to above the knee,

without signs of nerve root compromise” [1]. A systematic review has showed

that the global prevalence of LBP was 31.0%, and one-year prevalence was

38.0% [2].

Specifically, LBP can be classified by duration as acute (pain lasting less

than 6 weeks), sub-chronic (6 to 12 weeks), or chronic (more than 12 weeks)

[3]. A global systematic review has reported that the prevalence of CLBP

was linearly correlated with age between 30 and 60, and women generally

have a higher prevalence compared with men. Specifically, the individuals

aged between 20 and 59 have a CLBP prevalence of 19.6%, and the

prevalence of older people is 25.4% [4].The primary complaints of patients with

CLBP are pain and disability, and further consequences, including reduced

productivity and high medical cost, are also serious [5, 6]. Institute of Medicine

estimated that the direct annual loss due to CLBP was 34 billion dollars in USA

[7]. Global Burden of Disease Study 2013 showed that CLBP was one of the

leading specific causes of years lived with disability [8].

1.2. Change of treatment paradigm on CLBP and self-management model

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 According to International Association for the Study of Pain [9], “at the

chronic level, musculoskeletal pain is typically managed, but not cured.” As

one category of musculoskeletal pain conditions, CLBP should be managed

with effective, safe and low-cost approaches [10]. What’s more, advances

have been achieved in neuroimaging, molecular, and submolecular techniques

to treat CLBP, and etiology, mechanism, as well as treatment paradigm of the

condition have been reconceptualized [11]. Based on this paradigm change,

self-management model has been considered as a promising "treatment

package" to treat CLBP [11-12].

Self-management (SM) has been defined as “the individual’s ability to

manage the symptoms, treatment, physical and psychological consequences

and lifestyle changes inherent in living with a chronic condition” [13].

Specifically, SM model emphasizes the importance of interactive, collaborative

care between patient and health care professional rather than one-way,

passive care from expert to patient, allowing for patient empowerment [13]. In

the model, personal responsibility is encouraged for one’s day-to-day

management over the duration of disease [14]. As a collective term for a group

of interventions or “education package”, SM model consists of six essential

skills，which has been presented in Table 1 [12-20]. All the six elements

emphasize on individual’s responsibility for his/her health management, which

is core to self-management.

1.3. Advances in self-management programs on CLBP

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 Many trials have been performed to explore the role of self-management

program (SMP) on CLBP; however, the conclusions were inconsistent. Several

related systematic reviews have been conducted. By including 21 randomized

controlled trials (RCTs), van Tulder et al. found that behavioral treatment,

based on the behavioral therapy principle, has a moderate positive effect on

pain intensity and small positive effect on generic functional status [21]. In the

systematic review of Guzmán et al., intensive multidisciplinary biopsychosocial

rehabilitation with functional restoration was reported to have positive effects in

alleviating pain and improving function for patients with CLBP[22]. More

specifically, Toomey et al. has published a series of reviews to discuss the

effectiveness and implementation fidelity of SM interventions to promote SM

for people with osteoarthritis and CLBP, with the conclusion that no significant

difference of effectiveness was found between SM interventions and usual

management, and the overall levels of implementation fidelity were low [23,24].

Moreover, Keogh et al. [25] concluded that there is insufficient literature on

theoretically driven research of SMPs for CLBP. Specifically, the systematic

review of Oliveira et al. indicated that SM interventions have small effects on

pain and disability for people with LBP [6].

These studies have made important contributions to the clarification of the

role of SMP on CLBP. To our knowledge, however, there are four concerns in

previous studies. Firstly, some related systematic reviews did not focus on

self-management program as a particular intervention. Secondly, none of the

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published systematic reviews have considered what are primary outcomes and

secondary outcomes in each individual trial. It is considered to be

inappropriate to compare primary and secondary outcomes in a review

because different choice of the primary outcomes may reflect different

contents of intervention [26]. Thirdly, the systematic review of Oliveira et al. [6]

focused on SM interventions (not SM education package) in patients with LBP,

regardless of pain durations. There was no specific conclusion of the role of

SMP on CLBP. Fourthly, in a systematic review we have published in 2011, it

was found that there was then insufficient evidence to illustrate the

effectiveness of SMPs on for CLBP patients on pain intensity and disability [5].

It is essential to integrate subsequently published trials into systematic review

to update the conclusion.

1.4. Research Question and study design

Considering these concerns, we sought to quantitatively assess the effect

of SMP on CLBP using systematic review and meta analysis. Our research

question is “What is the effectiveness of SMP on patients with CLBP in terms

of pain intensity and disability?” .

2. Methods

2.1. Literature search

A search was performed in five English databases: Pubmed, Cochrane

Library, Web of Science, Elsevier (ScienceDirect), and CINAHL (Cumulative

-9-
Index to Nursing and Allied Health Literature), which have been checked from

their inception up to June, 2015. We used following MeSH (medical subject

heading) terms and text words: (“back pain” OR “chronic back pain” OR “low

back pain” OR “lower back pain” OR “chronic low back pain”) AND

(“self-management” OR “self-care” OR “patient education”) AND (“randomized

controlled trial” OR “random*” ), which was the summary of search strategy.

Meanwhile, cited reference retrievals were also performed.

2.2 Eligibility criteria

Only peer-reviewed randomized controlled trials (RCTs) were eligible.

Further, these studies should meet the inclusion criteria as following:

P (Population): Studies that examined adults (≥ 18 years old）with CLBP

were included. LBP is defined as “pain occurring in the lumbosacral region with

radiation limited to above the knee, without signs of nerve root compromise” [1].

Patients’ pain intensity should be 3 or above of a 0-10 pain scale (Visual

Analogue Scale (VAS), or Visual Numeric Scale (VNS)) [27]. Further, CLBP is

defined as the symptom of LBP which persists for more than three months (12

weeks) [3].

I (Intervention): Based on the criteria proposed by Warsi et al. [28], studies

of interventions that integrated systematic therapies into a SM or self-care

program were included. According to Lorig and other researchers [12-20],

qualified SMP consists of six essential skill elements, which have been

presented in Table 1. In particular, SM education studies, which involve

- 10 -
exclusively physical or psychological therapies, such as biofeedback,

relaxation techniques, exercise or group therapy, were excluded [28, 29].

What’s more, only the trials in which interventions primarily focused both on

managing pain and minimizing disability were qualified for inclusion.

C (Comparison): Studies in which SMP was compared with one of

following control forms: waiting-list/usual care/active controls, were all

considered eligible.

O (Outcome): The primary symptoms of patients with CLBP are pain and

disability [5, 6]. As a result, each eligible trial should consider both pain

intensity and disability as two primary outcomes. Those trials in which pain and

disability were not considered as primary outcomes of interest were excluded

[5].

2.3. Study outline

Firstly, searches were performed in the five databases and relevant

titles/abstracts were retrieved. After the duplicate studies were identified and

deleted, one reviewer (SZD) screened the titles/abstracts of candidate articles,

and a second reviewer (LLH) separately read a random sample (50%) of titles

and abstracts. After obtaining the full texts of potential studies, two reviewers

(SZD and LLH) independently evaluated and selected the articles according to

the inclusion criteria. Then the two reviewers performed a consensus meeting

on final decision on screening and selection of studies. Additionally, cited

reference retrieval searches were also performed.

- 11 -
2.4. Quality critical appraisal

The quality of the selected studies was evaluated using quality appraisal

criteria for RCTs from Cochrane Handbook for Systematic Reviews of

Interventions 5.1.0 [30]. The criteria include seven items on random sequence

generation, allocation concealment, blinding of participant and personnel,

blinding of outcome assessors, incomplete data outcomes, selective outcome

reporting, and other possible biases (e.g., baseline imbalance, early stopping,

and source of funding). According to the Handbook, each item is rated as “low

risk of bias”, “unclear risk of bias”, or “high risk of bias”. In the trial of SM

interventions, it is difficult to blind the health-care provider or participants;

however, it is possible to blind outcome assessors [15]. As a result, blinding of

outcome assessors was considered as adequate. In general, we considered

trials with adequate generation of allocation sequence, adequate allocation

concealment, adequate blinding (assessor blinding), free from incomplete

outcomes, free from selective outcome reporting, and free from other bias to

be trials with low risk of bias. Revman 5.3.5 was used as the tool to appraise

the quality of studies [31]. The process was performed by two independent

reviewers (SZD and LLH).

2.5. Extraction of data

Baseline demographics data and SMP features were extracted from each

eligible RCT. Thus, the details were tabulated into a table.

We also extracted data of pain intensity and disability from each trial. For

- 12 -
pain intensity, the most frequently used scales for were VAS and VNS. For

them, higher score indicates more severe pain intensity. For disability, the most

frequently used scales were Roland-Morris Disability Questionnaire,

Multidimensional Pain Inventory and Pain Disability Index. For them, higher

score indicates more severe disability. Additionally, for studies which used

scales with a reversed scoring system, in which higher score indicates less

disability, we recalculated the data by subtracting the mean value from the

maximum value for the scale, and standard deviations remained unchanged

[30]. By this way, all scales have the same direction of scoring. All scores were

expressed with the means and standard deviations. If standard deviation was

unavailable, it was estimated according to methods endorsed in the Cochrane

Handbook [30]. Specifically, for group mean, we used the formula in the

Handbook to estimate standard deviation with p values, standard errors or

confidence intervals presented in articles [30].

We stipulated that outcome data were categorized as immediate

post-intervention, short-term (up to 12 weeks), intermediate (13–26 weeks,

closest to 6 months) and long-term (over 26 weeks, closest to 1 year) [32].

RCTs which fit any of the four follow-up periods were considered eligible, not

needing to fit all.

2.6. Statistical analysis

Meta-analysis was performed using software RevMan 5.3.5 [31]. In theory,

meta-analysis is a process consisting of two stages. Firstly, to explore the

- 13 -
intervention effect, a summary statistic is calculated for each study. Secondly,

a pooled intervention effect estimate is calculated as a weighted average of

the intervention effects estimated in the individual studies [30]. In practice, in

the interface of Revman 5.3.5, we entered the means, standard deviations,

and numbers of pain/disability outcomes of patients of both experimental group

and control group. After all the data in eligible studies have been entered, the

pooled result can be generated [31]. Specifically, by Revman 5.3.5, the

standardized mean difference (SMD) and the 95% confidence interval (95% CI)

were calculated. Cochrane handbook shows that the particular definition of

SMD used in Cochrane Reviews is the “effect size” (ES) known in social

science [30]. According to Warsi et al. [28], in SM model, effect size＜0.2 is

considered as small effect, 0.2 ~ 0.5 is moderate, and ＞0.5 is large. For

statistical heterogeneity, the chi-square and I2 tests were used for assessment

[30]. Given I2 <50% and p >0.1, a fixed effect model was applied. On the other

hand, given I2 ≥ 50% and p ≤ 0.1, the random effect model was adopted if

articles were considered clinically similar enough. Otherwise, descriptive

analysis was adopted instead of meta-analysis.

We used all time-point meta analysis method of repeated measures to

capture the trend of effectiveness over time, in which each of the time-points

reported in the trials is considered separately [33]. Sub-group analyses were

performed to explore the influence of characteristics of SMPs on effectiveness.

- 14 -
3. Results

3.1. Search Process

Search process was presented in Figure 1. The search of databases

resulted in 1,300 potential articles. Excluded on duplicates, titles, and

abstracts were 1,176 articles, leaving 124 articles requested for full texts. With

the full text of one study not found, 123 articles with full texts were available.

These retrieved articles were subsequently read and evaluated according to

the inclusion criteria, with 111 articles excluded at this stage. Meanwhile,

another one article was found based on the cited reference retrieval. Therefore,

13 studies were passed on to quality critical appraisal [34-46].

3.2. Quality critical appraisal

The risk of bias of the included trials was summarized in Figure 2. Six trials

(6/13) [34-37, 39, 41] had adequate random sequence generation. Two trials

(2/13) [37, 39] described the details of concealment. For performance bias,

one article [38] reported the use of blinding of participants (participants were

not informed of the purpose of the study). For detection bias, 2 trials (2/13) [38,

46] reported the use of assessor blinding. For attrition bias, 7 trials (7/13) [37,

39-41, 44-46] used the approach of intention-to-treat (ITT) analysis, 4 trials

(4/13) [34-36, 42] indicated that the drop-out participants did not differ in

socio-demographic variables from those who completed programs, and one

trial [43] had no drop-out participants. For selective reporting bias, all 13 trials

reported predefined outcomes. Considering other bias, all the 13 trials were

- 15 -
free from baseline imbalance bias. For early stopping, 3 trials reported sample

size or power calculation [39, 41, 46], and none of the 13 trials were stopped in

advance. The sources of funding were mentioned in 10 trials, except three

trials [38, 42, 43]. The sources of funding were academic funds, so we

considered the trials to be free from risk of source of funding bias. Overall, the

included 13 RCTs showed moderate quality.

3.3. Characteristics of eligible RCTs

Totally, 13 RCTs were considered eligible, of which the information was

listed in Table 2. Overall, the included 13 RCTs were from USA (n=5) [36, 39,

40, 44, 46], Germany (n=5) [34, 37, 42, 43, 45], Sweden (n=1) [35], Austria

(n=1) [38], and UK (n=1) [41], respectively.

The 13 RCTs totally allocated 2,188 patients with CLBP, among which

1,076 participants were allocated to SMP group, and 1,112 in control group. Of

them, 5 studies compared SMP to usual care [40, 41, 44-46], 5 studies

compared SMP to waiting-list control [34-36, 39, 42], and 3 studies used other

active controls, including exercise programs [37, 38] and occupational therapy

sessions [43].

3.4. Contents and implementation of SMP

3.4.1. Theoretical frameworks

Of the 13 RCTs, eight studies were theoretically driven, among which six

studies [34-37, 41, 43] used Cognitive Behavioral Therapy (CBT), while two

RCTs [39, 40] adopted Social Cognitive Theory (SCT).

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3.4.2. Education mode of programs

For program setting, 11 trials [35-42, 44-46] were performed in outpatient

settings while two trials [34, 43] were conducted in inpatient settings. For

delivery mode, nine trials [34, 37-39, 41-44, 46] adopted group sessions, three

trials [34,36,40] was individual-based, and one trial [45] used group sessions

combined with individual approach. For channel , eight trials [34, 37-39, 41-43,

46] used face-to-face mode to deliver programs, while the other five trials [35,

36, 40, 45, 46] applied internet-based strategy.

3.4.3. Skill elements and common techniques of programs

All the included RCTs meet the criteria of SM model listed in Table 1. More

specifically, five common interventions were extracted about CLBP

management: aerobic exercise in 11 trials [34, 36-44, 46], cognitive coping

skills training (e.g., coping with negative thoughts and feelings, including worry

and fear-avoidance beliefs) in eight trials [34-36, 39-41, 43, 46], encouraging

pain acceptance and normal activity in eight trials [36, 40-46], progressive

muscle relaxation and imagery in seven trials [34, 37, 39, 40, 42, 45, 46], and

ergonomic and posture training in five trials [34, 37, 40, 42, 44]. The

techniques of pain management were organized and delivered within the

framework of SMP.

3.4.4. Duration and intensity of programs

Eleven RCTs showed explicit information of program duration except two

articles [44, 46]. Eight RCTs (8/13) had an explicit duration shorter than two

- 17 -
months [35, 36, 38-43]. The median of the duration set was six weeks. For

face-to-face group sessions, the numbers of sessions ranged from 3 [43] to 18

[37, 42]. Meanwhile, the lengths of each session ranged from 30 min [42] to

150 min [34, 39].

3.5. Outcome analysis

3.5.1. Effect of SMP on pain intensity

Of the 13 RCTs, nine trials [34-38, 40-43] reported the pain data at

immediate post-intervention. The result showed that I2= 34%, p=0.15,

illustrating that there was a small statistical heterogeneity. Meta analysis

showed that, compared with control group, SMP had a moderate, significant

effect in reducing pain intensity at immediate post-intervention period.

[SMD=-0.29, 95% CI (-0.41,-0.18), p<0.00001] (Figure 3).

Five trials [35, 37, 38, 40, 46] reported the pain intensity data at

three-month follow-up or similar. The result showed that I2= 11%, p=0.34,

illustrating that there was a small statistical heterogeneity. Meta analysis

showed that, SMP had a moderate, significant effect in reducing pain intensity

at short-term follow-up. [SMD=-0.20, 95% CI (-0.33,-0.07), p=0.003] (Figure 3).

Three trials [39, 41, 46] reported the pain intensity data at six-month

follow-up. The result showed that I2=0%, p=0.43, illustrating that there was no

statistical heterogeneity. Meta analysis showed that，compared with control

group, SMP had a moderate, significant effect in reducing pain intensity at

intermediate-term follow-up. [SMD=-0.23, 95% CI (-0.40,-0.07), p=0.006]

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(Figure 3).

Four trials [37, 38, 41, 46] reported the pain intensity data at 12-month

follow-up. The result showed that I2=50%, p=0.11, illustrating that there was a

moderate statistical heterogeneity. Meta analysis showed that, compared with

control group, SMP had a moderate, significant effect in reducing pain intensity

at long-term follow-up. [SMD=-0.25, 95% CI (-0.40,-0.10), p=0.001] (Figure 3).

Due to the lack of specific data on means and standard deviations of pain

intensity, two studies [44, 45] were not included in meta analysis. In the study

of Lorig et al. [44], the mean change data from baseline showed that SMP had

a significant improvement in pain intensity compared with the control group at

12-month follow-up. In the study of Moessner et al. [45], an efficacy figure

demonstrated that SMP did not have a significant difference in pain intensity

compared with the control group.

3.5.2. Effect of SMP on disability

Of the 13 RCTs, nine trials [34-38, 40-43] reported the disability data at

immediate post-intervention. The result showed that I2=0%, p=0.48, illustrating

that there was no statistical heterogeneity. Meta analysis showed that,

compared with control group, SMP had a moderate, significant effect in

reducing disability at immediate post-intervention period [SMD=-0.28, 95% CI

(-0.39,-0.17), p<0.00001] (Figure 4).

Five trials [35, 37, 38, 40, 46] reported the disability data at three-month

follow-up or similar. The result showed that I2=18%, p=0.30, illustrating that

- 19 -
there was a small statistical heterogeneity. Meta analysis showed that,

compared with control group, SMP had a moderate, significant effect in

reducing disability at short-term follow-up [SMD=-0.23, 95% CI (-0.36,-0.11),

p=0.0004] (Figure 4).

Three trials [39, 41, 46] reported the disability data at six-month follow-up.

The result showed that I2=0%, p=0.62, illustrating that there was no statistical

heterogeneity. Meta analysis showed that, compared with control group, SMP

had a small but significant effect in reducing disability at intermediate follow-up.

[SMD=-0.19, 95% CI (-0.36,-0.02), p=0.03] (Figure 4).

Four trials [37, 38, 41, 46] reported the disability data at 12-month

follow-up. The result showed that I2=0%, p=0.52, illustrating that there was no

statistical heterogeneity. Meta analysis showed that, compared with control

group, SMP had a small but significant effect in reducing disability at long-term

follow-up. [SMD=-0.19, 95% CI (-0.34, -0.03), p=0.02] (Figure 4).

Due to the lack of specific data on means and standard deviations of

disability, two studies [44, 45] were not included in meta analysis. The RCT of

Lorig et al.[44] used the data of mean change from baseline to illustrate the

efficacy, while the RCT of Moessner et al. [45] displayed a figure. In both the

studies, SMPs showed significant positive effects in disability compared with

the control groups.

3.5.3. Subgroup Analysis

We performed subgroup analyses to investigate the possible influence of

- 20 -
RCTs’ characteristics on effectiveness. We chose four characteristics for

categorizing subgroups: education modes, use of theory, intensity (duration) of

programs, and control conditions. We focused on the results of immediate

post-intervention follow-up when the numbers of included studies were

relatively large. The results were presented in Table 3.

Specifically, about education mode, both face-to-face SMP subgroup and

internet-based SMP subgroup showed moderate, significant improvements on

pain intensity and disability compared with controls.

About the use of theory, RCTs based on CBT had an ES of -0.27

(p=0.0002) on pain intensity, and an ES of -0.24 (p=0.001) on disability. RCTs

based on SCT had an ES of -0.23 (p=0.002) on pain intensity, and an ES of

-0.29 (p=0.004) on disability. RCTs without theory showed encouraging trends

both in reducing pain (ES=-0.73, p=0.10) and disability (ES=-0.51, p=0.07).

About the intensity of the program, the median, six-week duration, was

selected as the cutoff point to perform sub-group analysis. RCTs with intensive

duration (duration > 6 weeks) had an ES of -0.22 (p=0.004) on pain intensity,

an ES of -0.28 (p=0.0002) on disability, while RCTs with less intensive duration

(duration ≤ 6 weeks) reached an ES of -0.45 (p=0.0008) on pain intensity, an

ES of -0.27 (p=0.001) on disability.

About control condition, subgroup analyses found that, both for the two

outcomes, trials with waiting-list control had the largest ES (ES of pain=-0.37;

ES of disability=-0.45), while in the subgroup with usual care control, ES of

- 21 -
pain was -0.24 and ES of disability was -0.23, which were similar to those of

the subgroup with exercise control (ES of pain=-0.25; ES of disability=-0.27).

3.6. Adverse events

None of the 13 trials reported any major adverse events due to SMP.

4. Discussion and conclusion

4.1. Discussion

4.1.1. Main findings

This study shows that SMP probably has a beneficial effect in improving

pain intensity and disability for CLBP patients. Specifically, the SMP has a

moderate, significant effect in reducing pain intensity across the first year. For

disability, there is a moderate, significant effect in improving the symptom at

immediate post-intervention and short-term follow-up; while intermediate-term

and long-term effects (within the first year) are small but significant. Our

findings are generally consistent with results of the study of Oliveira et al. [6],

and the study of van Tulder et al. [21].

4.1.2. Safety concern

For the safety consideration, none of the 13 trials reported any major

adverse events due to SMP, which means that SMP is a relatively safe strategy

for CLBP. There is insufficient evidence to prove that SMP is not safe for

patients with CLBP.

4.1.3. Subgroup analysis

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 Subgroup analyses were performed to investigate the possible influence of

RCTs’ characteristics on results, which were interpreted from the perspective

of immediate post-intervention follow-up.

For education mode, face-to-face subgroup and internet-based subgroup

had similar moderate effects on pain and disability, which means

internet-based strategy can also be considered as a potential useful strategy to

deliver SMP.

About the use of theory, CBT-based RCTs and SCT-based RCTs had

similar, moderate effects in reducing pain and disability, while trials without

theory had no statistically significant effect on pain or disability, just with

positive trends. Theoretically, Cognitive Behavioral Therapy (CBT) works to

solve current problems and change unhelpful thinking and behavior [47], and

Social Cognitive Theory (SCT), assumes that successful learning will be

achieved if a close identification exists between the observer and the model

and if the observer has a high level of self-efficacy [48]. The two theories are

well-confirmed types of explanations on relationships between psychology and

behavior, so they are scientific and well-founded in guiding the implementation

of SMP. It is believed that the use of a theory as a foundation to education

program can contribute to the success of the patient education process [49].

For the intensity of the program, we found that RCTs of intensive duration

(duration > 6 weeks) had a similar effect on disability (ES=-0.28) compared

with that (ES=-0.28) of RCTs of less intensive duration (duration ≤ 6

- 23 -
weeks). More surprisingly, less intensive trials showed a larger ES on pain

(ES=-0.45) compared with that (ES=-0.22) of intensive trials, which was

different from our hypothesis. We speculated that long-term program could

possibly lead to a declined patients’ adherence to intervention, resulting in less

positive outcomes [50]. The result and speculation need further verification

and clarification. Meanwhile, an appropriate duration of SMP is also an

important issue to be explored in future.

For control condition, subgroup with waiting-list control had larger ESs than

subgroups with exercise control or usual care control. From the perspective of

control intensity, waiting-list control equals to blank control, usual care is a

standard control, and exercise means specific active control [51]. It makes

sense that studies with less-intensity control demonstrate a larger effect for

experimental group.

4.1.4. Main innovations of this work

Based on a thorough literature search up to June 2015, RCTs of SMP on

CLBP were systematically collected and analyzed. In this study,

self-management interventions are viewed a holistic “education package”,

which has been considered as an important and effective form to perform

patient education [52].This study also updated the conclusion we have

reached in 2011, when there was insufficient evidence to prove the

effectiveness of SMP on CLBP.

For previous systematic reviews and meta-analyses [6, 23-25], it is a

- 24 -
common under-recognized problem that primary and secondary outcomes

were compared in the review. This method may be fraught with danger

because different primary outcomes may reflect different contents of

interventions and therefore, if these trials are combined together, the pooled

effects are difficult for interpretation [26]. Our study only included trials which

took pain and disability as primary outcomes of interest and focused on

managing pain and minimizing disability in interventions. By this way, all the

included RCTs have similar interventions with the aim of managing pain and

minimizing disability. This measure helps reduce clinical heterogeneity and

reach a more convincing conclusion.

Based on the literature review and previous research, we have proposed

explicit criteria of SMP on pain management. We hope that the criteria can play

some positive roles in developing SMPs in future, such as classifying

dimensions, choosing specific interventions, and distinguishing SM from other

health education models [14].

4.1.5. Adherence to reporting guidelines

To improve the reporting quality of this study, we organized this review

according to the guidelines of Preferred Reporting Items for Systematic

Reviews and Meta-Analyses (PRISMA) [53]. Specifically, about the 27-item

checklist, this review met all other 26 criteria except Item 5 (Protocol and

registration). Concerning the flow diagram, based on the original 4 phases in

the statement, we modified the flow chart by adding the step of quality critical

- 25 -
appraisal before including eligible RCTs, emphasizing that only the trials which

were appropriate enough in quality could be included.

4.1.6. Risks of bias within included trials

Usually, SMP is always multi-dimensional design, involving in many factors

and increasing the difficulty of controlling trials in population. We performed

quality appraisal of included RCTs. Overall, the included RCTs are of moderate

quality with some flaws in design. This consideration made our conclusion

conservative to some extent.

4.1.7. Limitations

There are two limitations. Firstly, for all time-point meta analysis of repeated

measures, there is a concern that maybe only a small number of RCTs are

eligible to perform meta analysis at some of the time points [33]. In our review,

this problem occurs and the numbers of included RCTs for some

meta-analyses were small, and conclusions may have a weak ability for

generalization. Secondly, there was some clinical heterogeneity among the

trials. However, by setting strict inclusion criteria and performing subgroup

analyses, we have tried to reduce and clarify the heterogeneity.

4.2. Conclusion

By integrating the latest RCTs, this study aimed to explore the effect of

SMP on pain intensity and disability of patients with CLBP. For patients with

CLBP, this review concludes that SMP has a moderate effect in alleviating pain

intensity across the first year. The programs also have a moderate effect in

- 26 -
improving disability at immediate and short-term follow-up while the

intermediate-term and long-term effects (within the first year) are small but

significant. Therefore, as a safe option, SMP can play a positive role in

symptom management for patients with CLBP.

4.3. Practice implications

This review highlights the role of SMP in managing pain and disability for

CLBP. With moderate-quality evidence, this SR and meta analysis

demonstrates that, as a safe strategy, self-management program has

moderate effect on pain intensity, and small to moderate effects on disability.

SMP is a favorable option of symptom management for patients with CLBP,

which can evoke their consciousness and enthusiasm of individual’s

responsibility for their own health, and also strengthen their capability of pain

self-management. To achieve a better effect, practitioners are advised to

systematically integrate common pain management interventions into a

self-management program. What’s more, theoretical frameworks, such as CBT

or SCT, should be selected as program foundations, so that the programs can

be developed and delivered more successfully. In addition to traditional

face-to-face sessions, internet-based approach can also be considered as a

useful and effective channel to deliver the program, which can assure more

access and convenience for program-receivers.

- 27 -
Acknowledgment

We wish to thank the three anonymous reviewers for their valuable and helpful

comments and suggestions.

Conflict of interest

The authors have no conflict of interest.

Ethical approval

Not required.

I confirm that the patient/person(s) have read this manuscript and given their

permission for it to be published in PEC.

Funding

This work was supported by grants from Youth Fund of Humanities and

Social Science Research Foundation, Ministry of Education, China, 2014

(Grant Name: Study on the self-management model in patients with chronic

low back pain based on Self-Efficacy Model; Grant No. 14YJCZH024),

Directing Program of Philosophy and Social Science Research

Projects in Institutions of Higher Education, Jiangsu Province, 2014 (Grant

Name: Study on the influencing factors of quality of life of patients with chronic

low back pain: an analysis based on self-efficacy as the mediator variable;

- 28 -
Grant No. 2014SJD140). The research was also sponsored by Qing Lan

Project of Jiangsu Province.

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Pubmed Web of CINAHL Cochrane Elsevier
Science
355 329 84 360 172

Potentially relevant articles identified and screened for retrieval (n=1300)

Excluded due to duplicate (n=350)

Articles retrieved for more detailed evaluation according to title/abstract

(n=950)

Excluded (n=826)
Subject: 286
Intervention: 143
Population: 126
Design: 192
Language: 23
Trial protocols: 50
Commentary: 6

Articles requested for full texts (n=124)

Full text unavailable (n=1)

Articles with full texts for further evaluation according to the inclusion
criteria (n=123)

Excluded (n=111)
Design: 6
Subject: 4
Criteria of self-management program:
34
Pain and disability not as primary
outcomes: 12
Population: 47
Duplicate: 1
Poster or conference abstract: 5
Trial protocols: 2

Eligible trial by cited reference

Studies passed on to quality critical appraisal (n=13,12+1)
retrieval (n=1)

Eligible RCTs included for analysis (n=13)

Figure 1. Flow chart of selection process

- 38 -
 Blinding of participants and personnel (performance bias)

Blinding of outcome assessment (detection bias)

Random sequence generation (selection bias)

Incomplete outcome data (attrition bias)

Allocation concealment (selection bias)

Selective reporting (reporting bias)

Other bias

Basler 1997 + – – – + + +

Buhrman 2004 + – – – + + +

Carpenter 2011 + – – – + + +

Ewert 2009 + + – – + + +

Friedrich 1998 ? – + + – + +

Haas 2005 + + – – + + +

Irvine 2015 ? – – – + + +

Johnson 2007 + – – – + + +

Keller 1997 ? – – – + + +

Linden 2014 ? – – – + + +

Lorig 2002 ? – – – + + +

Moessner 2012 ? – – – + + +

Von Korff 2005 ? – – + + + +

Figure 2. Risk of bias summary: review authors' judgments about each risk of bias
item for each included study.

- 39 -
1. Immediate post-intervention effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Basler 1997 4.08 2.11 36 4.18 2.37 40 6.0% -0.04 [-0.49, 0.41]
Buhrman 2004 34.3 16.8 22 39.6 16.3 29 3.9% -0.32 [-0.87, 0.24]
Carpenter 2011 5.2 1.5 63 5.7 1.7 68 10.3% -0.31 [-0.65, 0.04]
Ewert 2009 1.08 0.93 83 1.3 0.98 86 13.4% -0.23 [-0.53, 0.07]
Friedrich 1998 35.9 25.1 39 44 27.2 36 5.9% -0.31 [-0.76, 0.15]
Irvine 2015 2.23 1.2 199 2.52 1.29 199 31.5% -0.23 [-0.43, -0.04]
Johnson 2007 29.1 24.5 110 35.3 26.7 113 17.6% -0.24 [-0.50, 0.02]
Keller 1997 3.1 2.08 29 5.61 2.08 23 3.4% -1.19 [-1.79, -0.59]
Linden 2014 3.06 1.6 53 4.1 2.2 50 7.9% -0.54 [-0.93, -0.15]

Total (95% CI) 634 644 100.0% -0.29 [-0.41, -0.18]

Heterogeneity: Chi² = 12.03, df = 8 (P = 0.15); I² = 34%
-2 -1 0 1 2
Test for overall effect: Z = 5.22 (P < 0.00001)
Favours [experimental] Favours [control]

2. Short-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Buhrman 2004 36.2 20.4 21 32.6 21.6 26 5.0% 0.17 [-0.41, 0.74]
Ewert 2009 1.06 1.02 83 1.06 0.99 86 18.2% 0.00 [-0.30, 0.30]
Friedrich 1998 32.7 24.3 43 39.8 26.6 41 8.9% -0.28 [-0.71, 0.15]
Irvine 2015 2.11 1.46 199 2.55 1.41 199 42.3% -0.31 [-0.50, -0.11]
Von Korff 2005 4.9 2 119 5.3 1.9 121 25.7% -0.20 [-0.46, 0.05]

Total (95% CI) 465 473 100.0% -0.20 [-0.33, -0.07]

Heterogeneity: Chi² = 4.48, df = 4 (P = 0.34); I² = 11%
-2 -1 0 1 2
Test for overall effect: Z = 3.02 (P = 0.003)
Favours [experimental] Favours [control]

3. Intermediate-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Haas 2005 41.4 28.9 60 42.3 29.3 49 19.8% -0.03 [-0.41, 0.35]
Johnson 2007 26.1 23.5 105 35 28.4 98 36.6% -0.34 [-0.62, -0.06]
Von Korff 2005 4.2 2 119 4.7 2.2 121 43.6% -0.24 [-0.49, 0.02]

Total (95% CI) 284 268 100.0% -0.23 [-0.40, -0.07]

Heterogeneity: Chi² = 1.69, df = 2 (P = 0.43); I² = 0%
-2 -1 0 1 2
Test for overall effect: Z = 2.74 (P = 0.006)
Favours [experimental] Favours [control]

4. Long-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Ewert 2009 1.13 1.04 83 1.08 1.07 86 25.4% 0.05 [-0.25, 0.35]
Friedrich 1998 26.4 22.2 34 41.9 29.6 35 9.9% -0.58 [-1.07, -0.10]
Johnson 2007 27.9 26.1 102 36.4 27.3 94 29.0% -0.32 [-0.60, -0.04]
Von Korff 2005 4 2.3 119 4.7 2.1 121 35.6% -0.32 [-0.57, -0.06]

Total (95% CI) 338 336 100.0% -0.25 [-0.40, -0.10]

Heterogeneity: Chi² = 6.06, df = 3 (P = 0.11); I² = 50%
-2 -1 0 1 2
Test for overall effect: Z = 3.24 (P = 0.001)
Favours [experimental] Favours [control]

Figure 3. Forest of effect of self-management programs on pain intensity for

chronic low back pain

- 40 -
1. Immediate post-intervention effect

Experimental Control Std. Mean Difference Std. Mean Difference

Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Basler 1997 1.63 0.87 36 1.84 0.62 40 6.0% -0.28 [-0.73, 0.17]
Buhrman 2004 3.2 1.4 22 3.5 1.2 29 4.0% -0.23 [-0.79, 0.33]
Carpenter 2011 13.5 5.8 63 16.3 5.2 68 10.1% -0.51 [-0.85, -0.16]
Ewert 2009 0.89 0.81 83 1.15 1 86 13.3% -0.28 [-0.59, 0.02]
Friedrich 1998 22.4 16.3 38 26.6 16.4 36 5.8% -0.25 [-0.71, 0.20]
Irvine 2015 3.27 1.69 199 3.85 2.22 199 31.4% -0.29 [-0.49, -0.10]
Johnson 2007 7.4 5.3 110 8 5.3 113 17.7% -0.11 [-0.38, 0.15]
Keller 1997 2.21 1.68 29 3.62 1.66 21 3.6% -0.83 [-1.42, -0.24]
Linden 2014 19.94 12.21 53 21.14 14.8 50 8.2% -0.09 [-0.47, 0.30]

Total (95% CI) 633 642 100.0% -0.28 [-0.39, -0.17]

Heterogeneity: Chi² = 7.57, df = 8 (P = 0.48); I² = 0%
-2 -1 0 1 2
Test for overall effect: Z = 4.93 (P < 0.00001)
Favours [experimental] Favours [control]

2. Short-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Buhrman 2004 4 1.4 21 3.9 1.6 26 5.0% 0.06 [-0.51, 0.64]
Ewert 2009 0.86 0.92 83 0.87 0.87 86 18.2% -0.01 [-0.31, 0.29]
Friedrich 1998 17.8 15.7 43 24 15.7 41 8.9% -0.39 [-0.82, 0.04]
Irvine 2015 3.03 1.88 199 3.74 2.22 199 42.2% -0.34 [-0.54, -0.15]
Von Korff 2005 10.2 6.3 119 11.5 5.8 121 25.7% -0.21 [-0.47, 0.04]

Total (95% CI) 465 473 100.0% -0.23 [-0.36, -0.11]

Heterogeneity: Chi² = 4.87, df = 4 (P = 0.30); I² = 18%
-2 -1 0 1 2
Test for overall effect: Z = 3.56 (P = 0.0004)
Favours [experimental] Favours [control]

3. Intermediate-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Haas 2005 32.8 29.6 60 35.8 31.7 49 19.7% -0.10 [-0.48, 0.28]
Johnson 2007 6.5 4.7 105 8 5.4 98 36.6% -0.30 [-0.57, -0.02]
Von Korff 2005 9.2 6.6 119 10.1 6.4 121 43.7% -0.14 [-0.39, 0.12]

Total (95% CI) 284 268 100.0% -0.19 [-0.36, -0.02]

Heterogeneity: Chi² = 0.95, df = 2 (P = 0.62); I² = 0%
-2 -1 0 1 2
Test for overall effect: Z = 2.20 (P = 0.03)
Favours [experimental] Favours [control]

4. Long-term effect
Experimental Control Std. Mean Difference Std. Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Ewert 2009 0.83 0.95 83 0.95 0.97 86 25.2% -0.12 [-0.43, 0.18]
Friedrich 1998 16.1 12.6 34 24.1 18.7 35 10.0% -0.49 [-0.97, -0.02]
Johnson 2007 6.7 5.6 101 8 5.5 94 28.9% -0.23 [-0.52, 0.05]
Von Korff 2005 8.4 7 119 9.1 6.3 121 35.8% -0.10 [-0.36, 0.15]

Total (95% CI) 337 336 100.0% -0.19 [-0.34, -0.03]

Heterogeneity: Chi² = 2.25, df = 3 (P = 0.52); I² = 0%
-2 -1 0 1 2
Test for overall effect: Z = 2.40 (P = 0.02)
Favours [experimental] Favours [control]

Figure 4. Forest of effect of self-management programs on disability for chronic low

back pain

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 Table 1. Core skill elements of self-management programs

Core skills Operational definitions

Problem solving Patients are taught basic pain-solving skills, including problem
definition, generation of possible solutions (e.g., the solicitation
of suggestions from friends and health care professionals,
solution implementation), and evaluation of results [14].
Decision making Equipped with necessary knowledge enough, patients are able
to make day-to-day decisions in pain management to meet
common changes in pain condition [14].
Resource utilization Patients should be taught how to find and utilize resources in
detail, e.g., reminding them to contact several potential
resources at the same time [14].
The formation of aFor chronic pain management, the role of the health care
patient-provider provider is that of teacher, partner and professional supervisor.
partnership The patient should be able to report accurately the trends and
tempo of the pain, make informed choices about treatment, and
discuss these with the health care provider [14].
Goal-setting and actionGoal-setting refers to encouraging active participation of the
-planning patient in their management, providing shared outcomes for
clinicians and patients to work towards, and facilitating patients
to become more self-determining [19].
Action planning specifies where, when, and how to act, which
helps to form goals which are very specific (e.g., indicating
what will be done at what time) [20].
Self-tailoring Self-tailoring means that the individuals, based on learning the
principles for changing behaviors and self-management, are led
through structured self-management skills and then they can
choose specific behaviors on their own as appropriate [14].
Interventions which are individualized and tailored to each
individual are more effective than those that are
“one-size-fit-all”.

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 Table 2. Characteristics of included studies
※
Authors, Subjects Women, Duration / Intervention Control E
Year, Country % Follow-up
[Reference]
Basler et al, 76 CLBP patients75.6 12 weeks/ 12 weekly sessions of 150 min each. CBT elements Waiting-list In
1997, Germany with an average age Post-treatment were consisted of education, relaxation, modifyingcontrol G
[34] of 49.3±9.7 thoughts and feelings, pleasant activity scheduling, Fa
EG: n=36; training of posture.
CG: n=40

Buhrman et al, 2004,51 CBLP patients62.5 8 weeks/ Internet-based self-help treatment consisting ofWaiting-list O
Sweden with an average age Post-treatment, 1-week self-monitoring, 6-week treatment, andcontrol In
[35] of 44.6±10.4. 3 months 1-week assessment; Treatments were consisted of In
EG: n=22 education, cognitive skill acquisition, behavioral an
CG: n=29 rehearsal, generalization and maintenance. su

Carpenter et al, 2011,141 CBLP patients83.0 3 weeks/ An interactive online self-help CBT interventionWaiting-list O
USA aged 21 years or Post-treatment consisted of six chapters, and therapeutic contentscontrol In
[36] older. including cognitive therapy, behavioral activation, In
EG: n=70 acceptance and commitment therapy, and
CG: n=71 mindfulness-based stress reduction. EG participants
completed two chapters each week and finished
them over three weeks.

Ewert et al, 183 nurses with 92.3 13 weeks/ A multimodal program consisted of 18 groupGeneral PhysicalO
2009, Germany CLBP with an Post-treatment, sessions; Topics included pain causes andExercise ProgramG
[37] average of 3 months, mechanisms, stress controlling techniques,of 11 one-hourFa
39.5±11.3. 12 months progressive muscle relaxation, communication skills,sessions.
EG: n=92 ergonomic and workplace advices, and segmental
CG: n=91 stabilization exercises.

Friedrich et al, Austria, 93 patients with50.5 10 sessions, and 2.3Exercise program; Exercise programO
[38] CLBP with an sessions per week/ Motivation program: extensive counseling andconsisted of 10G
average of 3.5 weeks after entry, information strategies; reinforcement techniques;sessions. Fa
44.12±10.66 4 months and 12 oral agreement between patients and therapists;
EG: n=44; months posting treatment contract for reminding; writing
CG: n=49 exercise diary.
Table 2. Characteristics of included studies (continued)
Authors, Subjects Women, Duration/ Intervention Control E
Year, Country % Follow-up
[Reference]
Haas et al, 2005, USA 109 community84.4 6 weeks/ A community-based, six 2.5-h weekly CDSMPWaiting-list O
[39] dwelling seniors with 6 months workshop taught by trained lay people; the course control G
CLBP with an was taught from a structural protocol to enhance Fa
average of 77.2±7.7; self-efficacy
EG: n=60;
CG: n=49

Irvine et al., 398 patients with60.6 8 weeks/ Based on self-tailored cognitive-behavioral approach, Usual care O
2015, USA CLBP▼. Post-intervention at 8 FitBack program was a 8-week multiple-visit online In
[40] EG: n=199; weeks; program with app’s responsive design, aiming to In
CG: n=199. Post-intervention at 16 encourage users to adopt appropriate pain
weeks. prevention behaviors. Participants also received 8
program emails with content and prompts related to
CLBP self-management.

Johnson et al., 2007,234 patients with59.8 6 weeks/ The community-based program was comprised of Usual care O
UK CLBP. Post-treatment; eight 2-hour group exercise session over 6 weeks. se
[41] EG:n=116 (mean 6 months; The key features encouraged self-management Fa
age: 47.3±10.9); 12 months post elements of back pain, including problem solving,
CG: n=118 treatment pacing and regulation of activity, challenging
(mean age: distorted cognitions, and helping patients to identify
48.5±11.4) helpful and unhelpful thoughts.

Keller et al., 64 patients with70.3 6 weeks/ The program included 18 2-h group meetings with 3Waiting-list O

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1997, Germany, CBLP in outpatient Post-treatment, times a week, and 18 30-min individualized trainingcontrol se
[42] setting in Germany. 6 months▲ sessions. Elements were as follows: Fa
EG: n=35 (mean Education aiming at a reconceptualization of pain;
age: 46.89±12.25); progressive muscle relaxation and imagery
CG: n= 29 (mean techniques and visualization; pleasant activity
age: 49.10±12.75). scheduling and distraction; training of posture and
Table 2. Characteristics
physical exercise. of included studies (continued
Authors, Subjects Women, Duration/ Intervention Control E
Year, Country % Follow-up
[Reference]
Linden et al., 2014,103 patients with68 2 weeks/ The patients received three 90-min sessions per Unspecific In
Germany CLBP with an Post-treatment week based on CBT, which aimed at problem occupational G
[43] average age of solving, self monitoring, stress reduction, pain therapy sessions Fa
50.8±6.9. management, change in dysfunctional cognitions,
EG: n=53 reduction of avoidance behavior, and wellbeing
CG: n=50 therapy.
Lorig et al., 421 patients from 4939.5 NR/ The program was comprised of three parts: (1) Usual care plus aO
2002, USA states with CLBP. 6 months◆, closed, moderated, e-mailed discussion group; (2) a subscription to aG
[44] EG: n=190 (mean 12 months after copy of The back Pain Helpbook; (3) a videotape non-health-relate In
age:47); baseline which showed how to perform an active life with d magazine of(E
CG: n=231 CLBP. their choice.
(mean age:45)
Moessner et al.,2012,75 patients with56.0 12–15 weeks/ The Internet-based aftercare intervention program for Usual care O
Germany, CLBP. 3 months, patients with CLBP was composed of two modules: In
[45] EG: n=40(mean age: 6 months (1) an individualized self-monitoring module aiming G
45.2 ±10.2); at improving the patients’ self-management; (2) A In
CG: weekly 90-min text-based Internet session, of which
n=35(mean age: the content was the transfer of behaviors learned
46.6 ±7.7) during treatment to daily life.

Von Korff et al., 240 primary CLBP62.5 NR/ A brief, individualized self-management program wasUsual care O
USA, 2005 patients. 2 months, comprised of four in-person visits which addressed G
[46] EG: n=119 (mean 6 months, fear-avoidance beliefs, encouraged activation, set Fa
age: 49.7±9.0); 12 months, goals and developed an action plan to increase
CG: n=121(mean 24 months after activity levels. Subjects also received a book on back
age: 49.8±9.8 ) randomization pain self-management and a 40-min videotape on
back pain self-care.

Abbreviations:
CBT: Cognitive-Behavioral therapy;
CDSMP: Chronic Disease Self-Management Program;
CG: Control group;
CLBP: Chronic low back pain;
DDS: Düsseldorfer Disability Scale;
EG: Experimental group;
MPI: Multidimensional Pain Inventory;
NR: Not reported;
NRS: Numerical Rating Scales;
PDI: Pain Disability Index;
RMDQ: Roland-Morris Disability Questionnaire;
TPB: Theory of Planned Behavior;
VAS: Visual Analogue Scale;
VNS: Visual Numeric Scale.

Notes:

※ For internet-based programs, the duration means the period of time from beginning to
- 44 -
 end for which the program lasts. Participants receive program information via Internet at
regular intervals, and they can start a new phase of programs after they have finished the
former task designated for them. Step by step, the programs can be delivered and
implemented.
* Primary mode for each trial is listed first.

Sub-group Category ES of pain intensity at post-intervention ES of disabilit

ES, 95% CI P value ES, 95%
Education mode Face-to-face program [34, -0.37,[-0.61, -0.13] 0.002 -0.23,[-0.38,
37, 38, 41-43]
Internet-based program -0.26,[-0.42,-0.09] 0.002 -0.34,[-0.50,-
[35, 36, 40]
Theory-based orCBT-based [34-37,41,43] -0.27,[-0.42,-0.13] 0.0002 -0.24,[-0.38,-
not SCT-based [40] -0.23, [-0.43,-0.04] 0.02 -0.29,[-0.49,-
Not theory-based [38, 42] -0.73,[-1.59, 0.14] 0.10 -0.51,[-1.07,

Intensity ofIntensive(duration ＞ 6 -0.22 [-0.37,-0.07] 0.004 -0.28,[-0.43,-

programs weeks）[34,35,37,40]
Less intensive (duration -0.45,[-0.71,-0.19] 0.0008 -0.27,[-0.43,-
≤ 6 weeks）
[36,38,41-43]
Control condition Waiting-list control -0.37,[-0.60,-0.14] 0.001 -0.45,[-0.68,-
[34-36, 42]
Usual care control -0.24,[-0.39,-0.08] 0.003 -0.23,[-0.39,-
[40, 41]
Exercise control -0.25,[-0.51,-0.00] 0.05 -0.27,[-0.53,
[37, 38]
# Self-efficacy theory (SET) is an extension of social cognitive theory (SCT) and a part of
SCT.
▼ This was a 3-arm randomized controlled trial, and we only listed the data of the two
groups: treatment group (the FitBack intervention) and usual care group.
▲ No data of the control group were available.
◆ No data were available at 6-month follow-up period for meta-analysis.
★ The authors had a discussion in the article to explain the possible contribution of
self-efficacy to the positive health status outcomes, although they did not specify the exact
framework and behavioral model of the trial.

Table 3. Sub-group analyses of self-management programs on

pain intensity and disability

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Abbreviations:
CBT: Cognitive-Behavioral therapy;
CI: Confidence interval;
ES: Effect size;
N.A.: Not applicable;
SCT: Social Cognitive Theory.

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