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Received: 16 July 2019 

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  Accepted: 9 December 2019

DOI: 10.1111/sms.13613

ORIGINAL ARTICLE

Patellofemoral pain: One year results of a randomized trial


comparing hip exercise, knee exercise, or free activity

Alexandra Hott1   | Jens Ivar Brox2,3  | Are Hugo Pripp4  | Niels Gunnar Juel3  |


Sigurd Liavaag5

1
Department of Physical Medicine
and Rehabilitation, Sørlandet Hospital
Objective: Extended follow-up of a randomized trial comparing hip-focused exer-
Kristiansand, Kristiansand, Norway cise, knee-focused exercise, and free physical activity in patellofemoral pain (PFP).
2
Faculty of Medicine, University of Oslo, Methods: A single-blind randomized controlled trial included 112 patients aged
Oslo, Norway
16-40 years (mean 27.6 years) with a clinical diagnosis of PFP ≥3 months (mean
3
Department of Physical Medicine and
39 months) and pain ≥3/10 on a Visual Analog Scale. Patients were randomized to
Rehabilitation, Oslo University Hospital,
Oslo, Norway a 6-week exercise-based intervention consisting of either isolated hip-focused exer-
4
Oslo Centre for Biostatistics and cises (n = 39), traditional knee-focused exercise (n = 37), or free physical activity
Epidemiology, Oslo University Hospital, (n  =  36). All patients received the same patient education. The primary outcome
Oslo, Norway
5
measure was the Anterior Knee Pain Scale (AKPS, 0-100). Secondary outcomes
Department of Orthopedic Surgery,
Sørlandet Hospital Kristiansand, were usual and worst pain, Tampa Scale of Kinesiophobia, Knee Self-Efficacy Score,
Kristiansand, Norway Euro-Qol (EQ-5D-5L), step-down test, and isometric strength. Blinded observers as-
sessed outcomes at baseline, 3, and 12 months. The study was designed to detect a
Correspondence
Alexandra Hott, Department of Physical difference in AKPS >10 at 12 months.
Medicine and Rehabilitation, Sørlandet Results: After 1 year, there were no significant between-group differences in any
Hospital Kristiansand, Norway.
Email: alexandra.hott@sshf.no
primary or secondary outcomes. Between-group differences for AKPS were as fol-
lows: knee versus free physical activity −4.3 (95% CI −12.3 to 3.7); hip versus free
Funding information
This study was funded by The Research
physical activity −1.1 (95% CI −8.9 to 6.7); and hip versus Knee 3.2 (95% CI −4.6
Department of Sørlandet Hospital. to 11.0). The cohort as a whole improved significantly at 3 and 12 months compared
to baseline for all measures except for knee extension strength.
Conclusion: After 1 year, there was no difference in effectiveness of knee exercise,
hip exercise, or free physical activity, when combined with patient education in PFP.

KEYWORDS
anterior knee pain, exercise therapy, hip strengthening, patellofemoral pain syndrome, patient education

1  |   IN T RO D U C T ION Patellofemoral pain is a clinical diagnosis defined by


pain around or behind the patella during loading, in the
Patellofemoral pain (PFP) is a common cause of pain in the absence of other specific pathology. The etiology of PFP
lower extremity. Its estimated annual prevalence is 23% in is incompletely understood. Current theories postulate
the general population and 29% in adolescents, with females that anatomical, biomechanical, psychosocial, and behav-
approximately twice as commonly affected as males.1 ioral factors contribute to PFP.2 Pathomechanics of the
patellofemoral joint, influenced by factors including mus-
Location: This study was performed at the department of Physical cle strength and control, are thought to be important.2,3
Medicine and Rehabilitation, Sørlandet Hospital, Kristiansand, Norway.

Scand J Med Sci Sports. 2020;30:741–753. wileyonlinelibrary.com/journal/sms © 2019 John Wiley & Sons A/S.     741 |
Published by John Wiley & Sons Ltd
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Psychological factors and pain sensitization are likely also 2.2  |  CONSORT statement and flow chart
important in PFP.4,5
Exercise is considered a mainstay in treating PFP.6,7 This trial has been designed and reported in accordance with
Traditionally, exercise for PFP has been knee-focused the CONSORT guidelines for reporting of randomized con-
with emphasis on strength and coordination in quadriceps trolled trials.25
muscles,8 while hip-focused exercise has received increas-
ing attention more recently.8,9 The most recent Cochrane
systematic review concludes with consistent but very 2.3  | Patients
low-quality evidence for exercise as a treatment for PFP,
and insufficient evidence to recommend a specific type of The study was performed at the Department of Physical
exercise.8 Although expert recommendations advocate the Medicine and Rehabilitation at Sørlandet hospital. Patients
combined use of hip and knee exercise, the relative con- anticipated to have PFP were referred by primary care phy-
tributions of the components are unclear.6,7 The results of sicians or by other medical specialists (eg, Orthopedic sur-
studies investigating hip-focused exercises compared to geons, Rheumatologists). Patients were screened with x-ray,
knee-focused exercise are inconsistent, with some studies MRI, and clinical exam by a specialist in physical medicine
reporting superior short- and/or long-term effects of hip and rehabilitation.
exercise compared to knee exercises,10,11 while others re-
port no difference.12,13
Current recommendations also consider patient educa- 2.3.1  |  Inclusion criteria
tion an important component of PFP treatment,6,7 although
a few studies exist. Two studies suggest that patient educa- Eligibility criteria were as follows: age 16-40  years, mini-
tion may be equally effective in reducing pain and function mum 3 months history of PFP, pain score for worst pain in-
as exercise-based interventions for PFP,14,15 while others find tensity during previous week of 3 or more on a Visual Analog
exercise to be superior to education alone.16,17 Factors such Scale (0-10, most pain), reproduced by at least two of the
as kinesiophobia and catastrophizing may be important to following activities: Stair ascent or descent, hopping, run-
address in PFP.4,18,19 Patient education of this type has been ning, prolonged sitting, squatting or kneeling and present on
used successfully in other chronic pain conditions such as at least one of the following clinical tests: Compression of
low back pain,20 but has not been studied in PFP. the patella or palpation of the patellar facets. In patients with
We have previously reported no significant differences in bilateral pain, the worst knee was included.
short-term effectiveness of isolated hip exercise to traditional
knee exercise or a control group performing free physical
activity in PFP.21 Long-term outcomes within PFP are of 2.3.2  |  Exclusion criteria
special interest, as newer surveys suggest higher degrees of
chronicity in PFP than has previously been appreciated.1,22,23 Clinical, x-ray, or MRI findings indicative of other specific
The goal of the present study was therefore to assess the long- pathology including osteoarthritis, meniscal, ligament or
term effectiveness of isolated hip exercises, traditional knee cartilage injury, apophysitis, recurrent patellar subluxation
exercise, or free physical activity, through an extended fol- or dislocation, significant knee joint effusion; hip or back
low-up of a randomized trial for which the 3-month results pain interfering with ability to perform prescribed exercises;
are previously reported.21 Non-steroid anti-inflammatory drug or cortisone use over an
extended period of time; previous surgery to the knee joint;
trauma to the knee joint affecting the presenting clinical
2  |  M AT E R IA L S A N D ME T HODS condition; physiotherapy or other similar exercises for patel-
lofemoral pain syndrome within the previous 3 months.
2.1  |  Study design

This is an extended follow-up of a randomized controlled 2.4  | Randomization


trial approved by the Ethics Committee Health Region
South-East, Norway (reference number: 2013/1860/ The randomization sequence was computer-generated,
REKsør-øst) and registered with the ClinicalTrials.gov stratified by sex, and consisted of blocks of a variable size,
database (reference number: NCT02114294). Recruitment unknown to any of the research team. The sequence was con-
took place between September 2014 and September 2017. cealed in opaque envelopes and stored by an independent
The full-trial protocol and 3-month results have been pub- nurse, who delivered them sequentially to the study physi-
lished previously.21,24 otherapist at randomization.
HOTT et al.   
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2.5  | Blinding adherence to the exercise program was recorded at the weekly
session with the physiotherapist.
The physiotherapists providing the interventions were blinded Patients performed three exercise sessions per week
to baseline measures. All outcome measures were collected by (one supervised and two home sessions) for 6 weeks. Initial
blinded observers. It was not possible to blind the patients or dosage was three sets of 10 repetitions for each exercise,
physiotherapists who provided the interventions. Patients’ ex- progressing to a maximum three sets of 20 repetitions.
pectations about the effectiveness of each intervention were as- Additional resistance thereafter was achieved through
sessed at baseline (Table 1). Statistical analysis was performed weights or elastic tubing depending on the exercise (see
blinded for the 3 month results.21 As the blinding was opened Appendix).21 Dosage was adjusted individually such that
in order to complete the 3-month manuscript, a blinded analysis the last repetitions were difficult while still maintaining
was not possible for the current report of 12-month outcomes. high movement quality throughout the entire program.
To avoid focus on pain, principles of operant condition-
ing were used,29 in which exercise quotas are set below the
2.6  | Interventions patient's limit of tolerance as opposed to training up to the
pain threshold.
2.6.1  |  Exercise dosage

Exercise dosages for hip and knee groups were matched and 2.6.2  |  Hip-focused exercise
were based on previous studies.11,26-28 Details are provided in
the Appendix and in a previous publication reporting the out- The hip-focused exercises were based on previous studies11,27
comes at 3 months.21 Patients received a written, illustrated and consisted of side-lying hip abduction, hip external rota-
manual in addition to personal instruction. Self-reported tion (clamshell), and prone hip extension. These exercises

T A B L E 1   Baseline Characteristics
Group Allocation Knee (n = 37) Hip (n = 39) Control (n = 36)
Age in years, mean (SD) 28.5 (6.2) 27.8 (8.6) 26.3 (7.0)
Gender (Female/male) 24/13 25/14 24/12
BMI, mean (SD) 26.9 (4.6) 25.9 (5.2) 26.4 (5.0)
Unilateral/bilateral 10/27 13/26 8/28
Symptom duration
3-6 mo 2 (5) 1 (3) 5 (14)
6-12 mo 7 (19) 5 (13) 11 (31)
12-24 mo 8 (22) 10 (25) 6 (17)
>24 mo 20 (54) 23 (59) 14 (39)
Higher education (>13 y) 11 (30) 10 (25) 12 (33)
Sick-listed 6 (16) 3 (8) 6 (16)
Regular use of analgetics 5 (14) 6 (15) 8 (22)
Use of insoles 4 (11) 3 (8) 9 (25)
Use of knee support or brace 5 (14) 9 (23) 5 (14)
Emotionally distressed 9 (24) 11 (28) 10 (28)
(HSCL ≥ 1.8)
Kinesiophobia
Normal to mild (13-32) 29 (78) 32 (82) 27 (75)
Moderate to high (33-52) 8 (22) 7 (18) 9 (25)
Expectation of effect (VAS 0 to 10), mean (SD)
for knee training 6.6 (2.3) 7.0 (2.3) 6.8 (2.4)
for hip training 6.6 (2.6) 6.9 (2.5) 6.6 (2.3)
for free activity 5.9 (2.3) 6.9 (2.3) 6.4 (2.6)
Note: Data presented as number (percent) unless otherwise specified.
Abbreviations: BMI, body mass index (kg/m2); EQ-5D, Euro-Qol index; HSCL, Hopkins Symptom Checklist;
n, number of participants; VAS, Visual Analog Scale.
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aimed to maximally isolate the posterolateral hip muscles that this may increase kinesiophobia.20 A shorter version
without stimulating the quadriceps muscles. of the same information (written and oral) was presented
again to all patients at the first meeting with the physi-
otherapist for randomization (approximately 30  minutes).
2.6.3  |  Knee-focused exercise All research personnel were instructed to communicate in
the same way with study patients, and meetings were held
The knee-focused exercise regime was based on previous at several points before and during the study to standardize
studies11,28 and consisted of supine straight leg raises, supine communication.
terminal knee extensions (from 10° flexion to full exten-
sion), and a mini-squat (45° flexion) with the back supported
against the wall (to reduce stabilizing requirements from the 2.7  |  Outcome measures
hip muscles). The exercises aimed to maximally isolate the
quadriceps muscles without stimulating posterolateral hip For this report, outcomes were assessed at baseline, at 3,
muscles. and 12  months after inclusion. Outcomes at 6  weeks and
3  months are previously reported.21 All outcome measures
are explained in detail in the published protocol.24
2.6.4  |  Control group (free physical activity)

At randomization, the control group met with the study 2.7.1  |  Primary outcome measure
physiotherapist and were encouraged by the physiothera-
pist to be physically active in accordance with the patient The main outcome was a forward-backward translated
education component but received no specific exercise and validated version of the Anterior Knee Pain Scale
regime. (AKPS).30 This self-report questionnaire consists of 13
questions assessing pain, symptoms and function, origi-
nally developed by involvement of patients with anterior
2.6.5  |  Patient education knee pain, patellar subluxation, and patellar dislocation.31
The Norwegian version was validated through hypothesis
All patients received the same standardized oral and writ- testing for construct validity in patients with PFP.30 Range
ten information in two sessions: at inclusion and randomi- 0 to 100 (least symptoms). The minimal clinically impor-
zation. The patient education component was intended to tant difference (MCID) of the original version is previously
address kinesiophobia and encourage self-mastery of symp- reported to be 10.32
toms. Previous research suggests potential importance of
these factors.18,19 The main patient education intervention
was delivered at inclusion, when all patients attended an 2.7.2  |  Secondary outcome measures
individual 1-hour consultation with a specialist in physi-
cal medicine and rehabilitation which contained elements Usual pain and worst pain last week were measured using
identified as important to patients in a former study inves- a Visual Analog Scale (VAS) from 0 to 10 (most pain). For
tigating the “good back consultation.”20 These elements these measurements, a MCID of 2 has been reported.32
include reassurance and explanations of pain mechanisms, The Tampa scale for kinesiophobia was used to assess fear
presented in conjunction with thorough patient-centered of movement/re-injury. Range 13 to 52 (most kinesiophobia).33
history and physical examination. Information focused on Self-efficacy (how certain the respondent feels about dif-
the benign nature of PFP as a “loading pain” as opposed ferent activities) was assessed with the Knee Self-Efficacy
to an “injury,” emphasizing that there was no evidence of Score. Range 0 to 10 (highest self-efficacy).34
injury to the structures of the knee. The presumed impor- Euro-Qol-5 Dimensions (EQ-5D-5L) was used to assess
tance of muscle strength and coordination in controlling health-related problems and quality of life.35 The Danish
the kneecap was explained, stressing that it is thought that index value calculator was used (range −0.62 to 1.00, best
exercise is important but it is unknown what type of exer- possible).35 EQ-VAS (0-100, best possible) recorded patients’
cise is best—including whether structured exercise is bet- self-rated overall health.35
ter than free physical activity. Patients were encouraged A step-down test was used to measure function.36 The
to gradually increase physical activity without excessively subject steps forward from a 20 cm step and down toward the
provoking knee pain. Traditional advice to focus on “cor- floor. For one repetition, the heel of the down limb touches
rect” biomechanical positions of the lower extremity or the floor before the up limb returns to full extension. The
avoid certain activities were not given, as we theorized measure is number of repetitions in 30 seconds.
HOTT et al.   
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Isometric strength was measured for hip abduction, hip <0.50 weak, from 0.50 to 0.79 moderate, and ≥0.80 strong.38
external rotation, and knee extension. Positioning external Between-group differences in number of patients seeking ad-
stabilization with straps were used based on validated tech- ditional treatment and analgetic use were tested using Pearson
niques.37 We used portable fixed dynamometry employing a chi-square analysis.
force sensor (MuscleLabTM 6000 ML Force Sensor 300 kg, Missing values in the questionnaires AKPS, TSK, KSES
Ergotest Innovation), which was considered a superior mea- and HSCL were treated as follows: If <25% of items were
surement device to handheld dynamometry. Standardized missing, the values were substituted with the arithmetic mean
procedures are based on existing techniques.37 Measures are of values from the available items.39 If ≥25% of items were
reported in Newtons. missing, the outcome measure was regarded as missing for
We chose a limit of 75% completion of exercise sessions the patient.
(home and supervised) to define full adherence to the proto-
col. Patients in the control group who received supervised
exercise therapy were defined as non-adherent. 3  |  RESULTS
3.1  | Patients
2.8  |  Sample size
317 patients with knee pain were evaluated for inclusion
The power and sample size calculations were based on a su- between September 2014 and September 2017. One hun-
periority trial design. Standard deviation of AKPS and pain dred and twelve patients were included and randomized,
(VAS) was assumed to be 13.5 and 2.25, respectively, based while 205 were excluded. Eighty-eight percent of patients
on previous studies.17 MCID for AKPS and pain were as- completed 12-month follow-up. For details, see flowchart
sumed to be 10 and 2.32 With these assumptions, 27 patients (Figure 1). Demographic and baseline characteristics were
were required in each of the three treatment groups to obtain similar between the groups (Table 1).
80% statistical power with 5% significance level for AKPS
and 19 in each group for pain. To account for possible miss-
ing data or dropouts, we planned to include 35 patients in 3.2  |  Missing data
each group.
There were generally few missing data (<5% for all patient-
reported outcomes), with the exception of muscle strength
2.9  |  Statistical analysis testing at 12  months, which 14 patients (Hip, n  =  6; knee,
n = 3; control, n = 5) were unable to attend and thus only
The main analysis used the principle of intention to treat submitted patient-reported outcomes. Missing data analysis
(ITT) including only cases with available follow-up data. The found no systematic differences between those attending
differences between the three treatment groups at 12 months muscle strength testing compared to those who did not. Thus,
were analyzed with an analysis of covariance model using the no imputation was performed.40
baseline value as a covariate. Assumptions of the model were
checked, and a Bonferroni correction was applied for these
analyses. In addition, repeated measurements were analyzed 3.3  |  Primary outcome
using linear mixed models with subject-specific random in-
tercept to assess the time course and the difference between We found no between-group differences in AKPS at
the groups. The model included the following fixed effects: 12  months by ITT analysis (Table 2 and Table 3). Linear
Outcome measurement of interest at baseline, follow-up time, mixed models analysis detected no significant group or
treatment group, and the interaction terms between follow-up time*group effect for repeated measures. The cohort as a
time and treatment group and between follow-up time and whole continued to improve slightly, and statistically sig-
outcome measure of interest at baseline. P-value ≤ .05 was nificantly, between 3 and 12  months: from 74.8 to 77.5
considered statistically significant. (P  =  .01). The effect size for AKPS improvement from
Post-hoc analyses included a per-protocol analysis com- baseline was 0.81 (large).
prising only patients who had fully adhered to the protocol by
the definition given above, for comparison with ITT analysis.
Improvement from baseline was assessed using paired-sam- 3.4  |  Secondary outcomes
ples t test. Effect size was calculated using Cohen's d for the
paired-samples t test (d = t/√N), where t is the T-statistic and We found no significant between-group differences at
N is the sample size. Effect sizes were interpreted as follows: 12 months for any secondary outcome measures (Table 3). We
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746       HOTT et al.

F I G U R E 1   CONSORT (Consolidated Standards of Reporting Trials) flowchart. n, number

found no significant group effect for any secondary outcomes outlier in the knee group for percent change in knee ex-
in linear mixed models analysis. In general, 3-month improve- tension at 12 months (>8 SD from the mean). Sensitivity
ments were maintained at 12 months (see Table 2 and Figure 2). analysis using non-parametric tests showed no major dif-
The effect size for improvement from baseline to 12 months was ference in result with or without the outlier. Thus, Figure 3
0.66 for usual pain (moderate), 0.70 for worst pain (moderate). is presented with the outlier.
Significant between-group differences in hip abduc-
tion strength and knee extension strength at 3 months were
no longer significant at 12 months (Table 3). The hip and 3.5  | Compliance
knee groups improved significantly for nearly all muscle
strength measures at 3 and 12  months, while the control Compliance was high, with 88% of patients adhering to the
group did not improve significantly on any muscle strength protocol (knee group 84%, hip group 92%, control group 92%).
measures (Table 2 and Figure 3). There was one extreme There were no significant differences in compliance between
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T A B L E 2   Primary and secondary outcomes at baseline, 3, and 12 mo

Outcome Knee (n = 37) Hip (n = 39) Control (n = 36) All (n = 112)


Primary outcome, mean (95% CI)
AKPS (0 to 100)c
Baseline 67.2 (62.7 to 71.7) 64.5 (61.1 to 97.9) 65.3 (61.2 to 69.5) 65.3 (63.0 to 67.6)
a a a
3 mo 74.4 (69.8 to 79.0) 73.1 (69.5 to 76.7) 73.1 (68.2 to 78.0) 73.5 (71.1 to 75.9)a
a a,b a
12 mo 76.6 (70.4 to 83.0) 77.6 (73.4 to 81.8) 78.7 (73.0 to 84.4) 77.7 (74.7 to 80.7)a,b
Secondary outcome, mean (95% CI)
Usual pain (VAS 0 to 10)
Baseline 4.3 (3.6 to 5.0) 4.4 (3.8 to 4.9) 3.7 (3.0 to 4.4) 4.1 (3.8 to 4.5)
3 mo 2.6 (1.8 to 3.4)a 2.9 (2.4 to 3.5)a 3.2 (2.5 to 3.9) 2.9 (2.5 to 3.3)a
a a a
12 mo 2.8 (1.7 to 3.9) 2.8 (2.1 to 3.4) 2.2 (1.4 to 3.0) 2.6 (2.1 to 3.1)a
Worst pain (VAS 0 to 10)
Baseline 6.0 (5.2 to 6.8) 6.5 (5.8 to 7.1) 5.8 (5.1 to 6.5) 6.1 (5.7 to 6.5)
a a
3 mo 4.0 (3.0 to 5.1) 4.9 (4.1 to 5.7) 5.0 (4.1 to 5.9) 4.7 (4.1 to 5.1)a
12 mo 3.7 (2.5 to 4.9)a 4.4 (3.6 to 5.3)a 3.5 (2.4 to 4.6)a,b 3.9 (3.3 to 4.5)a,b
Kinesiophobia (TSK 13 to 52)
Baseline 27.2 (24.9 to 29.5) 26.8 (24.9 to 28.6) 27.2 (25.0 to 29.4) 27.1 (25.9 to 28.2)
3 mo 24.5 (21.8 to 27.1)a 24.5 (22.5 to 26.4)a 25.9 (23.6 to 28.3) 24.9 (23.6 to 26.2)a
12 mo 24.5 (21.7 to 27.3)a 25.1 (22.8 to 27.3) 23.7 (21.3 to 26.1)a,b 24.5 (23.1 to 25.8)a
c
Knee self-efficacy (KSES 0 to 10)
Baseline 6.2 (5.6 to 6.8) 6.2 (5.6 to 6.8) 5.8 (5.1 to 6.3) 6.0 (5.7 to 6.3)
a a a
3 mo 7.1 (6.3 to 7.8) 7.0 (6.5 to 7.6) 6.4 (5.7 to 7.1) 6.8 (6.5 to 7.2)a
a a a,b
12 mo 6.9 (6.1 to 7.1) 6.8 (6.1 to 7.5) 7.1 (6.3 to 8.0) 6.9 (6.5 to 7.4)a
Euro-Qol-5D-5L index (−0.62 to 1.00)c
Baseline 0.75 (0.70 to 0.80) 0.76 (0.73 to 0.80) 0.73 (0.69 to 0.78) 0.75 (0.72 to 0.77)
a
3 mo 0.82 (0.78 to 0.85) 0.80 (0.76 to 0.83) 0.77 (0.73 to 0.82) 0.80 (0.77 to 0.82)a
12 mo 0.80 (0.75 to 0.86) 0.79 (0.75 to 0.83) 0.83 (0.79 to 0.88)a,b 0.81 (0.78 to 0.83)a
c
Euro-Qol VAS (0 to 100)
Baseline 64.3 (58.5 to 70.2) 66.6 (59.4 to 73.7) 62.9 (57.4 to 68.4) 64.6 (61.1 to 68.1)
3 mo 67.0 (60.4 to 73.5) 71.1 (64.3 to 77.9)a 68.7 (62.8 to 74.6)a 69.0 (65.4 to 72.6)a
12 mo 67.0 (60.5 to 75.0) 74.5 (70.1 to 80.6)a 68.7 (61.9 to 75.4)a 70.8 (67.1 to 74.4)a
Step-downd
Baseline 15.6 (13.6 to 17.6) 16.7 (15.2 to 18.2) 16.4 (14.4 to 18.4) 16.2 (15.2 to 17.3)
a a a
3 mo 19.2 (16.8 to 21.6) 19.5 (18.1 to 20.9) 19.2 (16.7 to 21.6) 19.3 (18.1 to 20.5)a
a a a
12 mo 18.9 (16.1 to 21.8) 20.0 (18.4 to 21.6) 19.3 (16.4 to 22.2) 19.4 (18.1 to 20.8)a
Hip abduction strengthe
Baseline 126 (110 to 141) 138 (124 to 152) 138 (122 to 154) 134 (126 to 142)
3 mo 145 (131 to 159)a 149 (134 to 163)a 135 (119 to 151) 143 (135 to 151)a
12 mo 144 (126 to 161)a 153 (137 to 168)a 140 (119 to 161) 146 (136 to 156)a
e
Hip external rotation strength
Baseline 103 (88 to 118) 111 (96 to 125) 114 (97 to 131) 109 (101 to 118)
3 mo 119 (104 to 133)a 123 (110 to 136)a 117 (101 to 133) 120 (112 to 128)a
12 mo 125 (108 to 142)a 127 (112 to 142)a 123 (102 to 144) 125 (115 to 135)a,b
Knee extension strengthe
Baseline 317 (272 to 362) 321 (283 to 358) 337 (289 to 386) 325 (300 to 349)

(Continues)
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T A B L E 2   (Continued)

Outcome Knee (n = 37) Hip (n = 39) Control (n = 36) All (n = 112)


a
3 mo 313 (279 to 357) 342 (307 to 376) 319 (270 to 368) 327 (304 to 350)
a
12 mo 327 (285 to 369) 343 (303 to 384) 335 (280 to 389) 335 (310 to 360)
Note: Unadjusted values are given.
Abbreviations: AKPS, Anterior Knee Pain Score; VAS, Visual Analog Scale.
a
Significant improvement from baseline at the P ≤ .05 level using paired-samples t test.
b
Significant improvement from 3 mo at the P ≤ .05 level using paired-samples t test.
c
Higher value indicates better function.
d
Step-down, number in 30 s.
e
Muscle strength, Newtons.

the groups. Post-hoc per-protocol analyses did not result in 4.1.2  |  Exercise dosage
differing conclusions from the intention-to-treat analyses.
The ideal exercise dosage in PFP is not known.41 To our
knowledge, only one previous study has specifically addressed
3.6  |  Additional treatment the question of dosage in PFP.42 Their results suggested a dose
effect, finding superior results with higher number of repeti-
Additional treatment was sought by 4 (12%) of the knee group, tions than usual (30 repetitions per set vs 10 repetitions per
1 (3%) of the hip group, and 6 (19%) of the free training group set). Based on this and other studies having shown success
(P  =  .1). Analgetic use did not differ significantly between with a similar approach,10,26,27 we chose a higher number of
groups at any point during the study (P > .4 at all time-points). repetitions for the present study. With respect to exercise type,
schedules and dosages in the guided exercise programs in the
current study are comparable to previous studies.10-12,15,26,28,41
4  |   D IS C U S S ION
We found no difference in the long-term effectiveness of either 4.1.3  |  Muscle strength
knee exercise, hip exercise, or free physical activity in patients
with patellofemoral pain. The cohort as a whole improved In the current study, we found that improvements in muscle
in clinical outcomes. The clinical improvements observed at strength for the two guided exercise groups did not trans-
3 months were maintained or further improved at 12 months. late to superior clinical results. Esculier et al15 observed the
The two guided exercise groups experienced superior gains in same phenomenon in their study comparing gait retraining,
muscle strength compared to the control group, but this did not therapist-guided exercise, and patient education for runners.
translate to better clinical outcomes in the short or long term. They found no between-group differences in pain and func-
tion despite superior gains in muscle strength for the exercise
group, and superior gains in step rate for the gait retraining
4.1  |  Comparison to previous studies group. That clinical improvements are not necessarily tied to
improvements in muscle strength is observed in two previous
4.1.1  |  Hip versus knee exercises systematic reviews.9,43 This may suggest that clinical improve-
ments may be moderated by factors other than muscle strength.
Previous studies show conflicting results comparing hip exer-
cises with knee exercises. Two small studies (16-18 patients
per group) have found isolated hip exercises to be more effec- 4.1.4  |  Patient education
tive than knee exercises in the short and/or long term10,11 while
one multi-center RCT including 199 patients found no differ- Previous research regarding patient education compared to exer-
ences in pain and function at 6  weeks12 or 6  months.13 The cise-based intervention in PFP is conflicting. Four studies have
latter is consistent with our lack of between-group differences compared patient education to complex exercise-based interven-
in clinical outcomes between hip- and knee-focused exercise tions. Rathleff et al16 found that the addition of exercise resulted
in the short term or long term. We note that many hip exercise in superior results to education alone in adolescents and that
protocols also stimulate the knee and vice versa, especially ex- better adherence to exercise improved odds of recovery. Van
ercise performed in weight-bearing positions,11 which is likely Linschoten et al17 found exercise superior to education alone for
to influence comparisons between exercise components. patients recruited from general practice and not those recruited
HOTT et al.   
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   749

T A B L E 3   Adjusted mean differences (95% CI) between-group at 3, and 12 mo

Outcome Hip versus Control Knee versus Control Hip versus Knee
Primary outcome, mean (95% CI)
AKPS (0 to 100)a
3 mo 1.0 (−4.6 to 6.6) 0.2 (−5.5 to 6.0) 0.8 (−4.8 to 6.4)
12 mo −1.1 (−8.9 to 6.7) −4.3 (−12.3 to 3.7) 3.2 (−4.6 to 11.0)
Secondary outcome, mean (95% CI)
Usual pain (0 to 10)
3 mo −0.6 (−1.6 to 0.4) −0.9 (−1.9 to 0.2) 0.2 (−0.8 to 1.3)
12 mo 0.2 (−1.1 to 1.5) 0.3 (−1.0 to 1.7) −0.1 (−1.4 to 1.2)
Worst pain (0 to 10)
3 mo −0.4 (−1.8 to 1.1) −1.0 (−2.4 to 0.5) 0.6 (−0.9 to 2.0)
12 mo 0.6 (−1.0 to 2.3) 0.1 (−1.6 to 1.9) 0.5 (−1.2 to 2.2)
Kinesiophobia (13 to 52)b
3 mo −1.0 (−3.8 to 1.7) −1.5 (−4.3 to 1.3) 0.5 (−2.3 to 3.2)
12 mo 1.7 (−1.6 to 5.0) 1.1 (−2.3 to 4.4) 0.6 (−2.6 to 3.8)
a
Knee self-efficacy (0 to 10)
3 mo 0.3 (−0.5 to 1.2) 0.3 (−0.5 to 1.2) 0.0 (−0.8 to 0.8)
12 mo −0.7 (1.8 to 0.4) −0.7 (−1.9 to 0.4) 0.0 (−1.1 to 1.1)
Euro-Qol 5D-5L (−0.62 to 1.00)a
3 mo 0.02 (−0.04 to 0.07) 0.03 (−0.02 to 0.09) −0.02 (−0.07 to 0.03)
12 mo −0.07 (−0.14 to 0.01) −0.05 (−0.13 to 0.03) −0.02 (−0.09 to 0.06)
Euro-Qol VAS (0 to 100)a
3 mo −0.8 (−8.4 to 6.8) −2.2 (−10.0 to 5.6) 1.5 (−6.1 to 9.0)
12 mo 3.7 (−5.4 to 12.9) −2.1 (−11.4 to 7.2) 5.9 (−3.2 to 14.9)
c
Step-down
3 mo −0.2 (−2.3 to 2.0) 0.4 (−1.8 to 2.5) −0.5 (−1.6 to 2.6)
12 mo −0.1 (−3.2 to 3.1) 0.2 (−3.1 to 3.4) −0.2 (−3.3 to 2.9)
Hip abductiond
3 mo 10.9 (−3.7 to 25.5) 17.9 (2.7 to 33.2)* −7.2 (−21.7 to 7.6)
12 mo 8.5 (−9.5 to 26.5) 9.8 (−8.2 to 27.8) −1.3 (−18.9 to 16.2)
d
Hip external rotation
3 mo 8.1 (−6.6 to 22.9) 10.3 (−4.9 to 25.6) −2.2 (−16.8 to 12.4)
12 mo 10.2 (−7.3 to 27.7) 15.2 (−2.6 to 33.0) −5.0 (−22.1 to 12.0)
Knee extensiond
3 mo 34.9 (3.9 to 65.9)* 19.4 (−12.8 to 51.5) 15.6 (−15.1 to 46.2)
12 mo 20.8 (−14.3 to 56.0) 25.2 (−9.9 to 60.3) −4.4 (−38.7 to 29.9)
Abbreviations: AKPS, Anterior Knee Pain Score; VAS, Visual Analog Scale.
a
Higher value indicates better function.
b
Lower value indicates less kinesiophobia.
c
Step-down, number in 30 s.
d
Muscle strength, Newtons.
*P = <0.05.

from sport physicians and that exercise did not improve the rate exercise to patient education based on load modification for
of self-reported recovery compared to education alone. Clark et runners and found no between-group differences in clinical
al14 found no significant difference in pain or function between outcomes. Thus, previous studies have not consistently shown
exercise and patient education, although patients performing ex- additional effect of complex exercise-based interventions over
ercise were more likely to be discharged from care, indicating patient education alone. The content and form of patient edu-
higher satisfaction. As detailed above, Esculier et al15 compared cation, exercise interventions, and patient characteristics varies
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750       HOTT et al.

F I G U R E 2   Time trends for mean values at baseline, 3, and 12 mo. Error bars represent 95% confidence interval. AKPS, Anterior Knee Pain
Scale (0-100, highest function); VASU, usual pain (0-10); VASW, worst pain (0-10)

F I G U R E 3   Percent change in
isometric strength for hip abduction (HAB),
hip external rotation (HER), and knee
extension (KEX) at 3, and 12 mo. Error
bars represent 95% confidence interval.
*Indicates significant change from baseline,
P < .05. Outliers are included

between all of these studies. As such, existing literature does not these factors.4,18,19 Our improvements in kinesiophobia and
support conclusions as to type of educational intervention which self-efficacy are relatively small—though this may partially
can be recommended for patients with PFP. be explained by baseline measures being collected after the
main patient educational component (which was delivered at
inclusion) for logistical reasons. Regardless, we suggest that
4.2  |  Interpretation of the results a more comprehensive cognitive-based intervention might
result in further improvements in kinesiophobia.29
The lack of between-group differences in clinical outcomes in
this study raises the question whether free training might be as
effective as therapist-guided exercises. In interpreting these re- 4.3  |  Implications for future research and
sults, it should be considered that the exercise programs aimed clinical practice
to isolate the muscle groups in question, as opposed to employ-
ing a complex or multimodal exercise-based intervention as is Although our results suggest the importance of patient edu-
most commonly used in PFP.6,7,9 Further, isolated exercises cation in PFP, the design of the present study did not allow
might be more effective if targeted to specific deficits, as theo- us to discriminate between the natural course, placebo and
rized by Selfe et al44 These factors might affect relative effec- nocebo and the control intervention (patient education com-
tiveness of guided exercise compared to the control group. bined with free training). To our knowledge, no study has
To our knowledge, this is the first study to use pa- compared the effectiveness of patient education alone to no
tient education attempting to influence kinesiophobia and treatment or placebo in PFP. Thus, this topic could be of in-
self-mastery in PFP, despite the potential importance of terest for exploration in future studies. Further, a cost-benefit
HOTT et al.   
|
   751

analysis comparing structured therapist-guided exercise to guided exercise groups showed superior improvement in
free training would be of relevance. muscle strength compared to the control group, but this did
not translate to superior clinical outcomes, which may sug-
gest that clinical improvement is mediated by factors other
4.4  |  Strengths of the current study than muscle strength. Our results raise the question whether
free training might be as effective as guided exercise for
The main strengths of the present study were adequate power, PFP. We suggest future randomized studies comparing free
good compliance, low rates of dropout (12%), and few missing training to guided exercise, for example, in a combined ex-
data. All observers collecting outcome measures were blinded ercise strategy as is commonly used in PFP. Further, com-
to group allocation. The physiotherapists who provided the in- paring patient education to no treatment or placebo should
terventions were blinded to baseline measures. Blinding of the be of interest, as no previous studies have investigated this
patients and physiotherapists to group allocation was not pos- question.
sible. Analysis of the 3-month results was performed blinded,
while was not possible for the 12-month results. Standardized ACKNOWLEDGEMENTS
oral and written information presenting all three interventions This study is funded by the Research Department of
as potentially equal aimed to reduce expectation bias. Patient Sørlandet Hospital. All authors declare no competing inter-
expectations to intervention effectiveness were similar between ests. We wish to thank the physiotherapists at the department
groups, suggesting success in this respect. The use of MRI at for Physical Medicine and Rehabilitation, Sørlandet Hospital
inclusion ensured that other knee pathologies were excluded. Kristiansand for performing the interventions and outcome
measures in this trial. We thank Anders Östling for coordi-
nating the intervention and Eirin Fidje Wessman for perform-
4.5  |  Limitations and considerations ing most of the data collection.

The relatively low recruitment rate (35%) may limit external ORCID
validity, although we have no reason to suspect that excluded Alexandra Hott  https://orcid.org/0000-0003-4438-3042
patients differed significantly from those who were included.
The study population has a long pain duration and/or low R E F E R E NC E S
baseline AKPS compared to some other studies,12,17,28,45 per- 1. Smith BE, Selfe J, Thacker D, et al. Incidence and prevalence of
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prognosis, as pain duration is a negative prognostic factor.46
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