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Journal of Back and Musculoskeletal Rehabilitation -1 (2017) 1–7 1

DOI 10.3233/BMR-169673
IOS Press

The effect of manual therapy and exercise in

patients with chronic low back pain: Double
blind randomized controlled trial
Ozlem Ulger, Aynur Demirel∗ , Müzeyyen Oz and Seval Tamer
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey

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Abstract.
BACKGROUND AND OBJECTIVES: To determine the effects of spinal stabilization exercises (SSE) and manual therapy

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methods on pain, function and quality of life (QoL) levels in individuals with chronic low back pain (CLBP).
METHODS: A total of one-hundred thirteen patients diagnosed as CLBP were enrolled to the study. The patients allocated
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into Spinal Stabilization group (SG) and manual therapy group (MG), randomly. While SSE performed in SG, soft tissue mo-
bilizations, muscle-energy techniques, joint mobilizations and manipulations were performed in MG. While the severity of pain
was assessed with Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Short Form 36 (SF-36) assessments were
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performed to evaluate the functional status and QoL, respectively. All assessments were repeated before and after the treatment.
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Results: Intragroup analyses both treatments were effective in terms of sub parameters of pain, function and life quality (p <
0.05). Inter group analyses, there was more reduction in pain and improvement in functional status in favor of MG (p < 0.05).
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CONCLUSIONS: This study showed that SSE and manual therapy methods have the same effects on QoL, while the manual
treatment is more effective on the pain and functional parameters in particular.
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Keywords: Low back pain, pain, rehabilitation, exercise, quality of life

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1. Background The problems seen in patients with CLBP origi-

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1 13

nated back pain related physical disability. There is 14

2 Many people have experienced low back pain at growing evidence that improvement in QOL and anx- 15
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3 any point in their lives [1] and ongoing low back iety is associated with gaining functional restoration 16

and treating CLBP become important. Surgery, mini- 17

4 pain at least three months defined chronic low back
mally invasive technics and physiotherapy and rehabil- 18
5 pain (CLBP). CLBP effects daily living activities of
itation approaches have been applied in the treatment 19
6 a person ranging from standing up, walking, bending
of CLBP. The most frequently applied physiotherapy 20
7 over, lifting, traveling, social interaction, dressing to
methods reported in the literature are TENS, thermal 21
8 sleeping [2]. While the increased number of people
agents, mobilizations and exercises. Such approaches, 22
9 with CLBP causes economic burden for countries both
also known as conventional approaches, have been 23
10 workforce loss and expensive treatment costs, living treating patients with CLBP, alleviating the severity 24
11 with ongoing pain causes depression, anxiety, deterio- and frequency of the pain, eliminating the functional 25
12 ration in QoL for patients themselves. limitations, contributing positively to the improvement 26

in QoL and avoiding workforce losses [1–7]. 27

∗ Corresponding
Manipulation and manual treatments are the most 28
author: Aynur Demirel, Department of Physio-
therapy and Rehabilitation, Faculty of Health Sciences, Hacettepe
applied methods within physiotherapy approaches in 29

University, Samanpazarı, Ankara 06100, Turkey. Tel.: +90 3123 051 recent years [8]. Through manipulations, manual treat- 30

576/168; E-mail: aynur.demirel@hacettepe.edutr. ment practices and biomechanical loading, the physi- 31

ISSN 1053-8127/17/$35.00
c 2017 – IOS Press and the authors. All rights reserved
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2 O. Ulger et al. / The effect of manual therapy and exercise in patients with CLBP

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Fig. 1. Flow diagram.

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32 ology of the muscle is altered by stimulating the neu- the participation criteria. 53

33 rons within the muscle tissue and the pain is reduced We required 112 patients in a balanced design, or 32 54

34 in a short period by increasing in the joint mobility patients in each group assuming an α level of 0.05, two 55
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35 based on the gate control theory [1–3]. The manipu- tailed test, and a power of 0.80. 56

36 lations have been reported to be an efficient treatment

method in patients suffering from acute and CLBP [1].
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37

38 However the clinical use of manual therapy practices is 4. Method 57

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39 getting popular, evidence based and studies comparing

40 manual methods and exercise therapy still lack [1,3–5]. The study has been conducted on patients diag- 58

41 For this reason, we have conducted the present study nosed with CLBP and who were referred to the 59
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42 with a view to identifying the effects of the spinal sta- Low Back and Neck Health Unit of the Hacettepe 60

43 bilization exercises and manual therapy practices on University, Health Sciences Faculty, Physiotherapy 61

44 pain, function and QoL levels of the patients suffering and Rehabilitation Department. Necessary authoriza- 62

45 from LBP in a comparative manner. tion and permits for this study have been secured 63

from the Non-Entrepreneurial Clinical Studies Eth- 64

ical Board of Hacettepe University, board resolu- 65

46 2. Objectives tion number GO131550-11. Clinical trial number is 66

NCT02696057. Out of 245 patients who had applied 67

47 This study was conducted with the aim of determin-
for a physiotherapy program from various polyclinics, 68
48 ing whether manual therapy or spinal stabilization ex-
197 patients were eligible for this study. Fifty-three re- 69
49 ercise was effective in pain, functional status and QoL.
fused to participate in the study, 29 failed to make time 70

for the study schedule and 2 were excluded from the 71

50 3. Sample size study as they failed to show up for the final assess- 72

ments. Flow diagram is seen in Fig. 1. 73

51 Randomization was performed by drawing lots among This study conducted with 113 patients with CLBP 74

52 the patients who had applied for the treatment and met who were allocated randomized into two groups: spinal 75
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O. Ulger et al. / The effect of manual therapy and exercise in patients with CLBP 3

Inclusion criteria
Diagnosed with CLBP
Pain severity of > 3 as per VAS
Ongoing pain for at least 3 months
Table 1
Inclusion and exclusion criteria
Exclusion criteria
Undergone spine surgery or failed back surgery
Having scoliosis
Having spinal neoplasm or metastatic disease
Having progressive neuropathy or progressive lumbosacral radiculopathy
Having rheumatoid arthritis with advanced joint involvement
Ongoing pharmaceutical medication
Having neurologic disease in addition to CLBP
Having systematic diseases and bladder disinfection

76 stabilization exercise group (SG) and manual ther- Second week: Different positions which included 114

77 apy group (MG). Patients were considered eligible if prone, sitting, standing and crawling positions added. 115

78 they met the following inclusion and exclusion criteria Third week: Side-lying positions and some stretch- 116

79 given in Table 1. ing exercise were added. For example: stretching for 117

hip flexor, back extensor or hamstring muscles. 118

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80 4.1. Randomization and blinding Fourth week: Bilateral movements and closed chain 119

exercises were added.

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120

81 Eligible patients allocated in two groups by us- Fifth week: Alternative movements and resistive 121

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82 ing block randomization method. According to com- band exercise were added. For example: resistive (band 122

83 puter generated random order, the patients were led is chosen according to patient’s strength) wrist exten- 123

84 to different physiotherapist. All the assessments were

done before and after therapy with same therapist who
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sion in crawling position, resistive knee extension in 124

85 crawling position, resistive shoulder flexion in stand- 125

86 was not assigned in treatment sessions. In MG, treat- ing or sitting position. 126
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87 ment was performed under the supervision of the same Sixth week: Exercise ball added to complicate the
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127

88 physiotherapist who practiced manual technics for ten movements. For example: sitting on ball, Mini Squat 128

89 years. In SG, exercise was performed another therapist. with keeping the ball between back and wall. 129
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90 Statistician did not know any personal data about sub- In the MG a series of methods consisting of soft 130

91 jects. Outcome assessor, statistician and physiothera- tissue mobilizations, muscle-energy techniques, joint 131

92 pist who involved in treatment sessions were blinded. mobilization and/or manipulations applied to patients 132
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depending on patient’s medical issue. Soft tissue mo- 133

93 4.2. Interventions bilizations were included myofascial stretching for su- 134
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perficial and deep muscles, transverse friction for inter- 135

94 Individualized spinal stabilization exercises were spinous and supraspinous ligaments. Muscle-energy 136
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95 performed under the supervision of same physiothera- techniques were included post-isometric relaxations 137
96 pist in SG. The program started with elementary/basic for quadratus lumborum and piriformis muscles. For 138
97 level exercises which included diaphragm respira- post-isometric relaxation, target muscle was located in 139
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98 tion and the co-contraction of Transversus Abdominus stretching positon and asked for the patients contract- 140
99 (TA) and core muscles, and moved on to intermedi- ing the muscle softly almost 8 seconds up to 30% of 141
100 ate and advanced level exercises (additional extrem- maximum voluntary contraction. It is repeated accord- 142
101 ity movements with the contraction of TA and Multi- ing to relaxation of muscle. Joint mobilization and ma- 143
102 fidus muscles, trunk stabilization and maintaining bal- nipulation was done according to sacroiliac mobility 144
103 ance over a ball, maintaining balance while standing, test. Sacroiliac mobility was assessed with standing 145
104 etc.) [6,7]. Advancing in SG according to weeks was flexion forward test, Gillet test, Piedallu Sign [9,10]. 146
105 shown in below. In all weeks, it is important to keep According to test results anterior or posterior mobiliza- 147
106 contracting TA and Multifidus muscles. The criteria tion or manipulation were applied. 148
107 moved on to next week is to keep contracting the TA Both groups received totally 18 sessions of therapy 149
108 and Multifidus muscles through ten seconds and be which lasted six weeks with three times in a week. One 150
109 able to repeat it ten times for all exercise of current therapy session was lasting almost sixty minutes. 151
110 step [8].
111 First week: Contracting TA and Multifidus muscles 4.3. Outcomes 152

112 together with diaphragm respiration appropriately in

113 supine position keeping good postural alignment. Demographic characteristics of patients including 153
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4 O. Ulger et al. / The effect of manual therapy and exercise in patients with CLBP

Table 2
154 age, sex, height, weight, and history of physiotherapy Demographic data of subjects
155 interventions were recorded before any therapy. Sen-
Manual therapy Spinal stabilization p
156 sorial loss assessed with Semmes-Weinstein monofil- Group (n = 57) Group (n = 56)
157 aments according to lower extremity dermatomes. Age (year) 41.6 ± 12.9 43.1 ± 14.3 0.45
158 It is known that Semmes-Weinstein monofilaments Sex (F/M) 35/22 32/24 0.37
159 used for gnostic sensory measurements [11,12]. The BMI (kg/m2 ) 26.2 ± 3.5 26.1 ± 4.4 0.89
Sacroiliac (%)26.3 (%)25 0.75
160 monofilament testing applied from 2.83 and higher.
dysfunction
161 The monofilaments applied to the skin three times and Sensorial loss (%)24.6 (%)19.6 0.87
162 if the patient felt stimulus, the point was recorded. BMI: Body Mass Index.
163 For detecting sacroiliac joint dysfunction five sacroil-
164 iac joint provocation tests which consists of FABER, age for Social Sciences Inc. Chicago, IL, USA) was 202
165 Gaenslen, Shear, sacroiliac compression and Sacroil- used for the statistical analysis. The compatibility of 203
166 iac distraction tests. At least three or more positive re- the data with normal distribution was reviewed visually 204
167 sponse of these tests indicated sacroiliac joint dysfunc- (by histogram and probability charts) and through an- 205
168 tion [13,14]. alytical methods. The Mann-Whitney U test was con-

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206
169 Every patient was evaluated according to the follow- ducted to identify the difference between the groups, 207

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170 ing clinical assessments both before and after the ther- while the Wilcoxon test was conducted to determine 208
171 apy by same physiotherapist different from the thera- the changes occurring after the treatment. The statisti-

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209
172 pist who applied interventions. cal significance level was acknowledged as p < 0.05. 210
173 Visual Analog Scale (VAS): The pain severity was ve
174 rated by patients in every sessions of before treatment
175 with VAS where 10-cm-long line’s left side indicates 5. Results 211
‘no pain’ and right side indicates ‘unbearable pain’.
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176
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177 The distance between the point marked by the patient

There were 67 female and 46 male patients with a 212
178 and the 0 point is measured in centimeters and the
mean age of 42.4 ± 13.6 years between the range of 213
value reveals the severity of the pain felt by the pa-
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179
20 and 73 years. The baseline mean scores of ODI 214
180 tient [15].
and VAS were 45 ± 17.6 and 6.4 ± 1.5, respec- 215
181 Oswestry Disability Index (ODI): Turkish version
tively. All participants had similar data in terms of age,
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216
182 of ODI was used to measure perceived functional dis-
body mass index, profession, family history, sensorial 217
183 ability levels due to chronic low back pain. This self-
deficits, sacroiliac joint dysfunction (p > 0.05). Demo- 218
administered, reliable and valid questionnaire consists
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184
graphic characteristics of subjects according to groups 219
185 of 10 items, each having a score of 0 to 5. ODI total
were seen in Table 2. 220
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186 scores ranges from 0 (no disability) to 50 (severe dis-

For both groups there was significant reduction in 221
187 ability) [6,16].
mean pain severity after treatment as to baseline (p < 222
188 Short form 36 (SF-36): Turkish version of SF-36
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0.001) with no significant difference in pain severity 223

189 was used to measure the changes in QoL levels due to
during activity between groups (p > 0.05). There were 224
190 chronic low back pain. This scale consists 36 items and
significant reductions in functional disability scores ac- 225
191 assesses various sub-parameters such as physical func-
cording to ODI both intra group and inter group analy- 226
192 tion, physical role difficulty, pain, general health, en-
ses. Improving in disability scores was higher in the fa- 227
193 ergy, social function, emotional role difficulty, mental
vor of MG (p < 0.05). There were significant improve- 228
194 health, etc. Each sub-parameter is scored on a scale of
ments in QoL levels according to SF-36 after treatment 229
195 0 to 100, where 0 is the lowest and 100 is the highest
as to baseline (p < 0.001), with no significant differ- 230
196 score [17,18].
ence among groups except the “bodily pain” subgroup 231
197 Minimal detectable change/Minimal clinical im-
of SF-36 (p > 0.05). Changes in outcome measures in- 232
198 provement were set at > 20 mm for VAS and 12.8 point
cluding pain severity, ODI and SF-36 were shown in 233
199 for ODI from baseline to the end of treatment [19,20].
Table 3. 234

The frequencies of data which had minimal de- 235

200 4.4. Statistical analysis tectable change were shown in Table 4. MG showed 236

higher effect size in terms of observed changes in pain 237

The SPSS statistical 16.0 software (Statistical Pack- 238

201 severity and functional improvement.
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O. Ulger et al. / The effect of manual therapy and exercise in patients with CLBP 5

Table 3
Changes in outcome measures
Groups Before treatment The end of the treatment P value
VAS (resting) Manual therapy 6.9 ± 1.48 [6.9–1.48] 2.08 ± 1.2 [1.4–3] < 0.001**
Spinal stabilization 5.27 ± 2.55 [2.2–4.6] 2.1 ± 1.6 [0.8–2.2] < 0.001**
P value < 0.003* 0.979 < 0.001**
VAS (activity) Manual therapy 8.26 ± 1.3 [7.5–8.9] 3.63 ± 1.8 [2.6–4.6] < 0.001**
Spinal stabilization 6.69 ± 1.6 [5.9–7.4] 3 ± 2.43 [1.9–4] < 0.001**
P value 0.001** 0.083 0.229
ODI Manual therapy 46.4 ± 18.1 18.9 ± 13.4 < 0.001**
Spinal stabilization 43.5 ± 17.1 23.5 ± 14.2 < 0.001**
P value 0.37 0.8 0.003*
SF-PF Manual therapy 40.8 ± 20.9 69.2 ± 18.7 < 0.001**
Spinal stabilization 36.9 ± 15.6 59.4 ± 15.2 < 0.001**
P value 0.30 0.004* 0.17
SF-RP Manual therapy 24.05 ± 30 58.9 ± 33.7 < 0.001**
Spinal stabilization 29.5 ± 22.1 54.4 ± 23.02 < 0.001**
P value 0.019* 0.22 0.11

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SF-BP Manual therapy 34.9 ± 17.6 59.3 ± 18.4 < 0.001**

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Spinal stabilization 37.1 ± 10.2 54.2 ± 13.2 < 0.001**
P value 0.31 0.096 0.009*

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SF-GH Manual therapy 49.1 ± 12.1 60.2 ± 13.7 < 0.001**
Spinal stabilization 47.1 ± 12.4 56.7 ± 10.6 < 0.001**

SF-VT
P value
Manual therapy
0.17
43.6 ± 14.6
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53.1 ± 16.8
0.675
< 0.001**
Spinal stabilization 43.6 ± 9.9 50.8 ± 10.9 < 0.001**
P value 0.85 0.375 0.591
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SF-SF Manual therapy 45.2 ± 24.2 61.9 ± 20.3 < 0.001**

Spinal stabilization 39.2 ± 14.3 56.6 ± 18 < 0.001**
P value 0.110 0.190 0.964
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SF-RE Manual therapy 42.9 ± 38.7 65 ± 31.5 < 0.001**

Spinal stabilization 45.6 ± 26.7 67.2 ± 24 < 0.001**
P value 0.591 0.766 0.611
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SF-MH Manual therapy 52.6 ± 17.3 61.8 ± 17.8 < 0.001**

Spinal stabilization 44.2 ± 14 57.1 ± 14.1 < 0.001**
P value 0.015* 0.327 0.086
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*p < 0.05, **p < 0.001. VAS: Visual Analog Scale, ODI: Oswestry Disability Index, SF: Short Form 36, PF: Physical Functioning, RP: Role
Physical, BP: Bodily Pain, GH: General Health, VT: Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health.
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Table 4
Minimal detactable change frequencies as to groups
The studies conducted up until 2008 on chronic non- 247

specific LBP suggest that exercise and cognitive train-

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248
Manual therapy Spinal stabilization
(n = 57) (n = 56)
ings as well as manipulation practices offer an inter- 249

n (%) ES n (%) ES mediate level of evidence [21]. Recent systemic re- 250

VAS (resting) 55 (96) 3.5 50 (89) 1.4 views suggested that the exercise should be used in 251

VAS (activity) 57 (100) 2.87 54 (96) 1.72 physiotherapy programs due to their high evidence lev- 252
ODI 49 (85) 1.6 35 (62) 1.26 els [22]. Additionally some studies showed strong ev- 253
ES: Effect size. idence for effectiveness of exercise therapy in chronic 254

239 6. Conclusion stages and moderate evidence for ineffectiveness in 255

acute stages [23]. Systematic reviews focused on ex- 256

240 We investigated the effectiveness of spinal stabiliza- ercise therapy highlighted that exercise programs must 257

241 tion exercise and manual therapy application on pain be individualized and needed regular therapist follow 258

242 functional disability and quality of live in patients with up [24]. Based on this idea, patient-specific posture, 259

243 CLBP. Although both treatments showed effective re- stretching and strengthening exercises included in both 260

244 duction in pain, improvement in function and QoL, groups and spinal stabilization exercises applied with 261

245 manual therapy was found more effective in terms of therapist guide. Stabilization exercises were proved to 262

functional improvement and pain relief. 263

246 be short and long term positive effects by support-
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6 O. Ulger et al. / The effect of manual therapy and exercise in patients with CLBP

264 ing dynamic control to lumbar spine and prevent re- mal detectable change of assessed variables more im- 315

265 injury [25]. proved subjects were detected in manual therapy group 316

266 Due to nature of CLBP, it is difficult to standardize in the present study. There were different cut off points 317

267 the interventions, so the present study conducted with for minimal detectable change for ODI and VAS, the 318

268 the same methods and different direction as to patient’s maximum values shown in recent papers were used 319

269 medical concern. Clinically, manual therapy combined to prevent type 2 error in the present study. Pain ad- 320

270 with exercise for management of pain in patients with versely affects the QoL individuals with LBP. Kosinski 321

271 CLBP so postural, stretching and strengthening exer- et al. [32] reported that the values in all categories of 322

272 cise was included to the present study. SF-36 were found to be low in patients with CLBP; the 323

273 When the studies reporting positive results about the most highlighted ones were physical function, physi- 324

274 effects of manual therapy and spinal stabilization exer- cal role limitation, pain, social function and physical 325

275 cises on the functionality of the patients with LBP are variable scores which were particularly lower than age 326

276 reviewed [22,26,27], it is not surprising to see func- and gender matched healthy individuals. Similarly, an- 327

277 tionality related improvements in both groups as a re- other study conducted with 350 LBP patients found 328

278 sult of this study. The present study and our clinical that 8 sub-scores of SF-36 were poorer than the gen- 329

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279 observations also confirmed that the patients in both eral healthy population. The lowest results were identi- 330

fied in the subscales of physical function, physical role

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331
280 groups were able to move around more comfortably at
281 the end of therapy. It is known that Sacroiliac joint pro- limitation and pain [33]. 332

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282 vide additional motion and by the way it helps L5-S1 Some limitations were noted for this study. Assessed 333

283 function [28]. It is confirmed that the re-functioning of outcome measures were planned to determine only ef- 334

284 the sacroiliac joint and spinal mobility – which were

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fectiveness or superiority of treatments and it is not
enough to make a cost efficiency calculation. Due to
335

336
285 initially evaluated with special tests and found dys-
286 functional – through manual therapy and spinal stabi- outcome measures performed only one assessor, it was 337
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difficult to fit the schedule to the patient. If the present 338
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287 lization exercises interventions had positive results on

288 functional restoration. study set interval assessments which treatment was 339

more effective in lesser time frame, we had more dis- 340

289 Aure et al. applied 8 week manual and general ex-
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cussion and richer results in terms of the controversial 341

290 ercise therapy and found manual therapy was more ef-
manual therapy and different physiotherapy practices. 342
291 fective than exercise therapy in terms of pain and func-
In conclusion, this study suggest that recommenda- 343
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292 tional status [29]. Although treatment period was dif-

tions and exercises intended for low back health as well 344
293 ferent from present study, we reached similar results
as the spinal stabilization exercises and manual treat- 345
294 with 6 week manual therapy and exercise intervention.
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ment methods commonly practiced have the same ef- 346

295 In contrast to Geisser et al. [30], the result of present
fect on pain, function and life quality. On the other 347
study support the notion that manual therapy have sig-
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296
hand, manual treatment is found to be more effective 348
297 nificant improvement in functional disability and pain
particularly in terms of pain and functionality param- 349
298 severity. Rasmussen et al. [31] found that stabilization eters. This study relies on the most frequently used 350
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299 exercise was more effective in terms of functional dis- methods in the literature that offer high evidence val- 351
300 ability than manual therapy in 12 month follow up due ues. We believe that exercise practices are important in 352
301 to exercise therapy was active approach in comparison planning treatments for the patients with chronic LBP 353
302 to the manual therapy. The subjects in manual therapy and that the treatment practices aiming to improve pain 354
303 group of our study performed postural, stretching and relief, clinical and functional conditions of the patients 355
304 strengthening exercise in addition to patient specific will also improve the functionality and life quality. 356
305 manual therapy approaches and it is possible that exer- Moreover, monitoring the functionality and life quality 357
306 cise combined with manual therapy has a greater effect of the patients will also be beneficial in following up on 358
307 on functional disability and pain relief than stabiliza- their response to the treatment. For further studies the 359
308 tion exercise group. long-term follow up and cost effectiveness calculation 360
309 Although the pain severity in manual therapy group is needed to make precise comments. 361
310 was higher than spinal stabilization group at baseline,
311 improvement after treatment was surprisingly higher
312 in manual therapy group. This result was also support Conflict of interest 362

313 the manual therapy was more effective than spinal sta-
bilization in terms of pain relief. According to mini- 363
314 None to report.
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