Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Taping

Akbas, 2011

Type of study:

RCT

Setting and country:

Hacettepe University,

Department of Orthopaedics and Traumatology, Turkey

Funding and conflicts of interest:
none

Inclusion criteria:

referred to

physiotherapy by an orthopaedic with a

diagnosis of unilateral patellofemoral pain; aged

between 17 and 50 years; female

Exclusion criteria:

tendonitis, Osgood-Schlatter syndrome,

known articular cartilage, meniscus or ligament

damage, history of patellar subluxation or dislocation

and previous knee surgery

N total at baseline:

I: 15
C:16

Important prognostic factors²:

age ± SD:

I: 41.00 ± 11.26
C: 44.88 ± 7.75

Sex:

0% M

BMI ± SD:

I: 25.17 ± 4.80
C: 28.64 ± 5.77

Groups comparable at baseline?
no significant differences reported

Describe intervention (treatment/procedure/test):
Taping + exercises:

kinesio taping at five days

intervals for six weeks + exerxises

Describe control (treatment/procedure/test):

Exercises:

muscle strengthening and soft tissue stretching exercises for six weeks

Length of follow-up:

6 weeks

Loss-to-follow-up (2 weeks):

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

VAS (SD), in rest

p>0.05

Function

Kujala (SD)

p>0.05

Arrebola, 2020

Type of study:

RCT

Setting and country:

orthopaedical specialty outpatient clinic at the

State Public Servant Institute of Sao Paulo, Brazil

Funding and conflicts of interest:
none

Inclusion criteria:

- women between the ages of 18 and

45 years who were irregularly active according to the International

Physical Activity Questionnaire criteria.
- a history of knee pain for at least 3 months
- reported increased pain in at least 3 PFP-related activities, such as

climbing stairs, jumping, kneeling, knee flexion for a long period, or

pain on palpation of the medial or lateral facet of the patella
- a body mass index (BMI) < 29.9 kg/m2

Exclusion criteria:

- knee osteoarthritis
- previous surgery

on the lumbar spine or lower limbs
- patellar or quadriceps

tendinopathy
- patellofemoral instability
- ligament or meniscal

lesion
- sensitivity to the material used in the application of the

KT method®
- attended <85%

of the physical therapy sessions, or if they presented with other

types of pain symptoms not associated with PFP, that interfered

with their performance during the exercise protocol period.

N total at baseline:

Intervention A: 13
Intervention B: 14

Control:16

Important prognostic factors²:

age ± SD:

Ia: 30.38 ± 8.40
Ib: 27.86 ± 9.38

C: 30.31 ± 7.91

Sex:

Ia: 0% M
Ib: 0% M

C: 0% M

BMI ± SD:

Ia: 24.37 ± 2.60
Ib: 23.37 ± 3.60

C: 22.68 ± 2.78

Groups comparable at baseline?
no statistical significant differences on baseline characteristics

Describe intervention (treatment/procedure/test):
Taping + exercises:

The KT® method applications were performed once a week

throughout the 12-week treatment protocol period. As recommended

by the Kinesio Taping® Association International (KTAI), a 3-5-day period of taping was used for maintenance.

A: taping was performed with the initial

anchorage on the suprapatellar region under 0% tension. The

therapeutic zone had a tension of >50% involving the entire lateral

region of the patella. The final anchorage was on the tibial tuberosity

with 0% tension

B: the participant's

lower limb was initially in the lateral rotation position before the

taping application. The initial anchorage was on the posterior superior

iliac spine under 0% tension. The therapeutic zone was in a spiral format throughout the extension of the patients' lower limbs

with tension of <50%. The tape involved the greater trochanter, the

medial femoral condyle, and the lateral region of the leg, ending at

the lateral malleolus region, with the final anchorage placed with

0% tension

Describe control (treatment/procedure/test):

Exercises:

The exercise protocol was based on hip and quadriceps

strengthening exercises. The exercises were performed in

all groups twice a week for 12 weeks by physiotherapists blinded to

the randomization.

1-4 weeks:
Strengthening exercises (80% 1RM): hip abductors,

quadriceps in closed kinetic chain, and triceps

surae (3 sets of 12 repetitions)

Strengthening with elastic resistance: quadriceps in

open kinetic chain and lateral hip rotators (3 sets

of 12 repetitions each)

4-8 weeks:
1-4 weeks strengthening plus motor control

exercises and core training (3 sets of 30 s each of

planks and lateral planks)

8-12 weeks:
1-4 weeks strengthening plus progression of the motor control

exercises to unstable planes and core training (3 sets of 1min

each of planks and lateral planks)

Length of follow-up:

6 weeks, 12 weeks and 24 weeks

Loss-to-follow-up (24 weeks):

Intervention a:

N=7 (54%)

Reasons: unknown

Intervention b:

N=9 (64%)

Reasons: unknown

Control:

N=11 (69%)

Reasons: unknown

In total:
6 weeks: 21%
12 weeks: 35%
24 weeks: 63%

It was hypothesized that the high drop-out ratewas related

to the improvement of pain and function observed at 6 weeks. Also, these patients had a low socioeconomic condition and could not

afford the transportation to the ambulatory clinic where the study took place, through the 12 weeks.

Incomplete outcome data:

Not further reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

NPRS (SD, numerical pain rating scale) at rest:

Between groups: p=0.952

NPRS (SD, numerical pain rating scale) during effort:

Between groups: p=0.404

Function

Kujala anterior knee pain scale (SD):

Between groups: p=0.686

Single jump hop test (meters):

Between groups: p=0.873

Sample size calculation shows that 16 subjects per group were needed.

Begum, 2020

Type of study:

RCT

Setting and country:

Fauji Foundation Hospital Rawalpindi, Islambad, Paikstan

Funding and conflicts of interest:
none

Inclusion criteria:

Not reported, but study was conducted on females with patellofemoral pain up to one year;

Exclusion criteria:

Not reported

N total at baseline:

I: 26
C:25

Important prognostic factors²:

age ± SD:

36.04 ± 7.35

Sex:

0% M

Groups comparable at baseline?
not reported

Describe intervention (treatment/procedure/test):
Taping + exercises:

McConnel Taping combined with strengthening exercises of vastus medialis oblique.

participants received traditional exercises for 4-5 days per week, 30-40 minutes of sessions for 2 weeks along with the McConnell taping

Describe control (treatment/procedure/test):

Exercises:

Strengthening exercises of vastus medialis oblique.

Patients were given exercises for 4 -5 days per week, 30-45 minutes of session for 2 weeks

Length of follow-up:

2 weeks

Loss-to-follow-up (2 weeks):

I: N=5 (19%)

Reasons: not reported

C: N=4 (16%)

Reasons: not reported

Incomplete outcome data:

Not further reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

NPRS (SD, numerical pain rating scale)

Function

LEFI (SD, lower extremity functional index)

Ghourbanpour, 2018

Type of study:

RCT

Setting and country:

Not reported

Funding and conflicts of interest:
none
Funding: Babol Iniversity of Medical Sciences

Conflicts: No

Inclusion criteria:

- 20-50 years
- anterior knee pain for at least one month
- feeling discomfort and pain during palpation of the edges of the medial and lateral side of the patella
- with worsening symptoms during prolonged sitting, climbing stairs, squatting, running, skipping and jumping
- with positive apprehension and clark tests
- feeling pain during resistive knee extension

Exclusion criteria:

- history of dislocation and direct trauma to the patella
- any rheumatologic conditions (osteoarthritis, rheumatoid arthritis)
- diabetes
- any trauma or meniscus injury
- ligamentous instability
- referred pain from the lumbar spine, hip, pelvis and sacroiliac regions
- remarkable knee joint inflammation and effusion
- knee surgery
- knee physiotherapy and steroid injection

N total at baseline:

I: 15
C:15

Important prognostic factors²:

age ± SD:

I: 33.85 ± 10.29
C: 37.15 ± 12.45

Sex:

Not reported

BMI ± SD:

I: 24.70 ± 6.76

C: 28.90 ± 4.99

Groups comparable at baseline?
no significant differences reported

Describe intervention (treatment/procedure/test):
Taping + exercises:

Strengthening exercises for quadriceps muscles with emphasis on

vastus medialis oblique, closed chain exercises, stretching exercises

for hamstring muscles and iliotibial band and patellar mobilization
Patellar taping was done according to the McConnell's method.

Patients were treated for 12 sessions during 4 weeks. New taping was applied in each treatment session

and tape maintained between treatments.

Describe control (treatment/procedure/test):

Exercises:

Strengthening exercises for quadriceps muscles with emphasis on

vastus medialis oblique, closed chain exercises, stretching exercises

for hamstring muscles and iliotibial band and patellar mobilization.

Patients were treated for 12 sessions during 4 weeks.

Length of follow-up:

4 weeks

Loss-to-follow-up (4 weeks):

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

VAS

Function

KOOS, activities of daily life (SD)

Return to sport

KOOS, sports and recreational activities (SD)

Gunay, 2017

Type of study:

RCT

Setting and country:

Department of rehabilitation medicine, Bülent Ecevit University Medical School, Zonguldak, Turkey

Funding and conflicts of interest:
none

Inclusion criteria:

- being within

the age range of 20 to 50 years
- having no limitation in

the range of motion of the knee joint
- having anterior or retropatellar knee pain in at least two activities (i.e., going down the stairs, climbing up the stairs,

squatting, running, jumping, sitting for a long time while the knees are at 90° flexion)
- having early onset anterior knee pain for at least the last six months

Exclusion criteria:

- history of knee trauma, prior knee operation (excluding arthroscopy)
-meniscopathy or lesion in the knee ligaments
- previous effusion and arthritis of the knee
- patellar subluxation

or dislocation
- limited range of motion of the ankle or the knee
- neuromuscular diseases (upper and

lower motor neuron lesions).

N total at baseline:

Ia: 25 knees
Ib: 25 knees
C:25 knees

Important prognostic factors²:

age ± SD:

Ia: 36.0 ± 8.0

Ib: 31.7 ± 8.5

C: 33.8 ± 6.7

Sex:

Ia: 31.3% M

Ib: 50% M
C: 61.5% M

BMI ± SD:

Ia: 25.6 ± 2.6

Ib: 24.2 ± 3.3

C: 25.2 ± 3.9

Groups comparable at baseline?
no statistical differences reported

Describe intervention (treatment/procedure/test):
Ia: Taping + exercises:

Ib: Sham taping + exercises

All three groups were given the same exercise

program during six weeks. Taping was applied twice a

week, 12 times in total during treatment period of six weeks.

Kinesiotape applications were performed according

to the method established by the Kinesio Taping

Association International. 5 cm width Kinesio® Tex

tapes were used for taping. All the taping processes

were performed by a specialist.

Ia: Kinesiotaping was applied with vastus

medialis obliquus facilitation and patellar functional

Ib: Sham taping

Describe control (treatment/procedure/test):

Exercises:

Stretching (quadriceps, hamstring, gastrocnemius

and iliotibial band) and strengthening (quadriceps,

gluteus medius) exercises were applied during six

weeks as two times a week (12 sessions) in the clinic by

the supervision of a physiotherapist. The patients were

informed and encouraged about the daily exercises at

home on the other days. Exercises were done in three sets with 10 times repetition.

Length of follow-up:

6 weeks, 12 weeks

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

VAS (median (min-max)

Function

Kujala patellofemoral score (median (min-max)

According to the power analysis,

66 patients were required (p=0.05, power=0.80, effect

size=0.40).

Bracing

Alsaharani, 2019

Type of study:

RCT

Setting and country:

Loma Linda University, CA, USA

Funding and conflicts of interest:
not reported

Inclusion criteria:

- male or female
- aged 18–45 years
- has exhibited patellofemoral pain

symptoms for more than 1 month
- have a pain level ≥3 on the Numeric Pain Rating Scale (NPRS)
- has experienced pain during at

least 2 functional activities, such as squatting, ascending/descending stairs, and/or running.

Exclusion criteria:

- traumatic injuries to the knee joint or lower-extremity
- displayed signs

or symptoms of a meniscus lesion or ligamentous-related pathology
- had been diagnosed with a neurological disorder, diabetes,

osteoarthritis, osteoporosis, or rheumatoid arthritis
- reported

taking any over-the-counter pain medications during the study

period

N total at baseline:
43 subjects, but 41 analyzed

I: 21
C:20

Important prognostic factors²:

age ± SD:

I: 30.8 ± 5.6
C: 26.7 ± 3.0

Sex:

I: 42.9% M
C: 60% M

BMI ± SD:

I: 24.4 ± 4.2
C: 26.8 ± 4.8

Groups comparable at baseline?
difference in age and lateral step-down test

Describe intervention (treatment/procedure/test):
Knee brace + exercises

Perform warm-up exercises, followed by specific therapeutic exercises that are part of the Protonic therapy program. The system includes a brace set to resist knee flexion and a set of specific exercises to perform daily.

First day of wk 1: 1 session
- Education, wam-up, walking
Wk 1-2: 3 sessions/wk
- walking, hamstring curl in supine, prone and sitting positions
Wk 3-4: 3 sessions/wk
- walking, hamstring curl in standing position

Describe control (treatment/procedure/test):

Sport cord + exercises:

The

same warm-ups and exercises as knee brace group, using the sport cord in the supine,

standing, sitting, and prone positions. The only difference is that subjects were asked to only walk backward instead of forward to avoid activation of the hip-flexor muscle.

Length of follow-up:

2 weeks, 4 weeks

Loss-to-follow-up:

2 participants (group not reported)
Reasons: meniscus lesion (1), personal time constraints (1)

Incomplete outcome data:

Not further reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

NPRS (SD, numerical pain rating scale)

P=0.9

Function

Kujala score (SD)

P=0.39

LSDT (SD, lateral step-down test)

All subjects were able to

perform significantly better on the LSDT postintervention (P <.001). The brace group exhibited a 133.3% improvement in their performance, whereas those in the sport cord group demonstrated

only an 85.3% improvement.

Uboldi, 2018

Type of study:

RCT

Setting and country:

Knee surgery unit of the G. Pini Orthopaedic Institute in Milan and the Orthopaedic Clinic of the University Hospital of Sassari, Italy

Funding and conflicts of interest:
Funding: not reported
Conflict of interest:none

Inclusion criteria:

- age between 16 and 35 years
- a diagnosis of anterior knee pain due to PFP
- a Tegner score of > 3
- a body mass index (BMI) between 18 and 26

Exclusion criteria:

- knee comorbidities, such as ligament, meniscus, or cartilage lesions

N total at baseline:

I: 35 (30 analyzed)
C:35 (30 analyzed)

Important prognostic factors²:

age ± SD:

20 ± 4

Gender:
22% male

BMI (range):

23 (18-26)

BMI

Groups comparable at baseline?
no significant difference reported

Describe intervention (treatment/procedure/test):
bracing + rehabilitation:

Reaction Knee Brace; DJO Global, Vista, California, United States

Describe control (treatment/procedure/test):

Rehabilitation:

The rehabilitation protocol was divided into different phases based on the patient’s progress. The goal of the first phase was to reduce pain and swelling, to

improve the balance between vastus medialis and vastus lateralis of the quadriceps muscle, to restore normal gait, and

to decrease loading of the patellofemoral joint. The second phase included improvement of postural control and coordination

of the lower extremity, increase of quadriceps and

hip muscle strength, and restoration of good knee function. The patients were encouraged to return to sports with a suitable regular physical exercise. The third phase included

functional exercises.

Length of follow-up:

3, 6, 12 months

Loss-to-follow-up (2 weeks):

I: N=5 (14%)

Reasons: no response (4), private reasons (1)

C: N=5 (14%)

Reasons: no response (3), private reasons (2)

Incomplete outcome data:

Not further reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

VAS (SD)

Function

Kujala score (SD)

Petersen, 2016

Type of study:

RCT

Setting and country:

Multicenter, Germany

Funding and conflicts of interest:
funding: not reported
conflicts of interest:
Wolf Petersen, Gert Peter Bru¨ggemann, Raymond

Best, Thore Zantop and Christian Liebau received consultant

fees from Otto Bock. Ingo Rembitzki is employee of Otto Bock. Sven

Scheffler and Mirco Herbort received fees for inclusion of patients

from Otto Bock.

Inclusion criteria:

Inclusion criteria consisted of a patient age between 18

and 50 years and the presence of three of the following

symptoms lasting longer than 2 months but not longer than

2 years: anterior knee pain when running, climbing stairs,

cycling, sitting with a bent knee, or performing squats

Exclusion criteria:

Kellgren-

Lawrence grade 3 to grade 4 osteoarthritis, local grade

3 to grade 4 cartilage damage as noted on magnetic resonance imaging and measured using the Gluckert grading system, subluxation of the patella, a history of

a previous knee injury (such as to the cruciate ligaments),

tendinosis of the patellar tendon, a history or active diagnosis

of Osgood–Schlatter disease, osteochondritis dissecans,

a varus knee with an intercondylar distance greater

than 2 fingerbreadths, and a valgus knee an intermalleolar

distance greater than 3 fingerbreadths

N total at baseline:

I: 78
C:78

Important prognostic factors²:

age ± SD:

I: 28.0 ± 9.4

C: 28.0 ± 8.1

Sex:

I: 34.2%
C: 21.1% M

BMI ± SD:

I: 23.0 ± 1.5

C: 23.0 ± 1.3

Groups comparable at baseline?
no significant differences reported

Describe intervention (treatment/procedure/test):
bracing + exercises:

Patellar brace (Patella Pro).

Patients were instructed to wear the brace over a minimum period of 6 weeks for at least 6 h a day.

Describe control (treatment/procedure/test):

Exercises:

patients entered a supervised exercise

and structured home exercise program (Patella Move program).

Patients were instructed to perform the home

exercises daily for 15 min for a period of 6 weeks. For

supervised exercises, all study participants received a prescription of about 12 sessions of Krankengymnastik am

Gera¨t. The duration of one session is 60 min. The

duration of the supervised exercise program was 6 weeks

(12 units).

Length of follow-up:

6, 12 and 54 weeks

Loss-to-follow-up (2 weeks):

I: N=11 (14%)

Reasons: lack of motivation (6), lost to follow-up (5)

C: N=16 (21%)

Reasons: lack of motivation (11), lost to follow-up (5)

Incomplete outcome data:

Not further reported

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

NAS

No significant group differences could be detected during

walking and at rest after 6, 12, and 54 weeks. Absolute

and percent changes in pain at rest and while walking also did not differ significantly between the brace and non-brace groups.

However, significant lower limb pain was assessed

while climbing stairs or playing sports for the brace group compared to the non-brace group after 6 and 12 weeks. The absolute and percent decrease in reported pain also differed significantly between the brace and non-brace groups in week 6 and 12. After 54 weeks, no significant differences between both treatment groups were noted

Results only reported in figures

Function

Kujala score

A significantly higher mean Kujala score compared with pre-therapy measurements was found for the brace group compared to controls at 6 and 12 weeks.

Results only reported in figures

KOOS

Significantly higher scores in the brace group could be

detected for the pain, symptoms, activities of daily living

(ADL) and quality of life (QoL) sub-scores at the 6- and

12-week time points. For the sports/recreational activities

(Sport/Rec) sub-score, a significantly higher score could

only be found after 12 weeks. After 54 weeks, significant

group differences could only be found in the ADL subscore.

Results only reported in figures

With a potential dropout

rate of about 15 %, approximately 156 patients must be

enrolled in this study to achieve a power of 0.80 and an

alpha of 0.05.

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Taping

Callaghan, 2012

SR and meta-analysis of RCTs

Literature search up to August 2011

A: Clark, 2000

B: Tunay, 2003

C: Whittingham, 2004

Study design:
A: RCT, parallel

B: RCT, parallel

C: RCT, parallel,

Setting and Country:

A: UK
B:Turkey
C:UK, military

Source of funding and conflicts of interest:

SR: University of Manchester, UK; University of Central Lancashire, UK; Department of Health Post-Doctoral Awart, UK; Arthritis Research, UK; no conflicts of interest

A: not reported
B: not reported
C: not reported

Inclusion criteria SR:
- RCT and quasi-randomised controlled trials evaluating patellar taping for adults with patellofemoral pain

- adults, aged 18 and above, diagnosed with patellofemoral pain.
- patellar taping
- outcome: pain; function; activity levels; quality of life
- timing immediately after the completion of a treatment programme/preferably at least six months follow-up when taping is used as part of a treatment programme

Exclusion criteria SR:

- treatment after patella fracture, dislocation or subluxation
- history of recurrent dislocation and subluxation
- concomitant neurological, rheumatological or cardiovascular problems
-outcome measures such

EMG (electromyogram) data, gait analysis, patellar position or

Alignment studied without pain evaluation

5 studies included (3 relevant for this review)

Important patient characteristics at baseline:

N, mean age

A: I: 20, Not reported per group
 C: 20, not reported per group

B: I: 20, Not reported per group
 C: 20, not reported per group

C: age: 18.7 years
Ia: n=10
Ib: n=10
C: n=10

Sex:

A: not reported per group

B: not reported per group

C: 80% Male

Groups comparable at baseline?
not reported

Describe intervention:

A: Patellar taping, exercise & education. Tape was applied from the lateral border of the patella

pulling medially and upwards over the medial femoral condyle. Taping in this way should reduce pain

on the squat test and wall/step down test. If this did not eliminate the pain then the taping was repeated in knee flexion. Type of tape used is not described.
Six treatments over period of 3 months. Length of time of each treatment not stated.

B: Patellar taping, ice and home exercises, treatment for 3 weeks

C:
Ia: Patellar taping + standardised exercise programme; Active taping technique (McConnel): underwrap

and one corrective strip of tape. Correction of patellar malalignments of tilt, rotation or glide as identified by the treating physiotherapist.
Ib: Placebo taping + standardised exercise programme; Placebo taping: underwrap and one strip of tape with no correction of patellar position.

Describe control:

A: Exercise & education
Education: leaflet “Knee pain in young adults” and sessions on (a) an explanation of the nature of anterior knee pain, the anatomy of the patellofemoral joint, and possible causes of anterior knee pain;

(b) footwear and appropriate sporting activities; (c) pain controlling drugs; (d) stress relaxation techniques, ice and massage; (e) diet and weight advice; and (f) prognosis and self-help.

Exercise: stretching to the hamstring, iliotibial band, quadriceps and gastrocnemius muscles. Eccentric, isotonic and isometric strengthening exercises to the lower limb
Six treatments over period of 3 months. Length of time of each treatment not stated.

B: Ice and home exercises, treatment for 3 weeks

C: Exercise programme alone: non–weight-bearing isometric, inner-range isotonic and straight leg raise quadriceps exercises. A variety of weight-bearing exercises (e.g., squats). Stretches for the quadriceps, hamstrings, gastrocnemius, and iliotibial band. No home exercise programme.

End-point of follow-up:

A: 3 months, 12 months

B: 3 weeks

C: 1,2,3,4 weeks

For how many participants were no complete outcome data available?

(intervention/control)

A: "10 patients withdrew from the study and these were included on an intention

to treat basis." Participant flow provided.

B: not reported

C: "All subjects remained in the group to which they were originally assigned."

Outcome measure-1: pain

VAS, after treatment

Effect measure: mean difference (95% CI):

A: 0.81 (-0.44, 2.06)

B: 0.35 (-0.43, 1.13)
C: -1.45 (-1.91, -0.99)

Pooled effect (random effects model:

-0.16 (95% CI -1.67 to 1.34) favoring taping

Heterogeneity (I²): 91.1%

VAS, 12 months

Effect measure: mean difference (95% CI):

A: -0.13 (-1.99, 1.73) (favoring taping

Outcome measure-2: function

FIQ, end of treatment

Effect measure: mean difference (95% CI):

C: 2.5 (-.82, 3.18) (favoring taping

Cincinnati knee activity score, end of treatment

Effect measure: mean difference (95% CI):

B: 8.1 (2.93, 13.27) (favoring taping

WOMAC score, end of treatment

Effect measure: mean difference (95% CI):

A: 1.5 (-6.24, 9.24) (favoring no taping

WOMAC score, 12 months

Effect measure: mean difference (95% CI):

A: -0.8 (-15.24, 13.64) (favoring taping

Facultative:

Brief description of author’s conclusion: the currently available evidence from trials reporting clinically relevant outcomes is low quality and insuLicientto draw conclusions on the eLects of taping, whether used on its own or as part of a treatment programme.

Risk of Bias due to issues regarding blinding and allocation concealment

Bracing

Smith, 2015

SR and meta-analysis of (RCTs / cohort / case-control studies)

Literature search up to May 2015

A: Evcik, 2010

B: Lun, 2005

Study design: RCT A: RCT, parallel
B: RCT, parallel

Setting and Country:
A: single center, Turkey
B: single center, Canada

Source of funding and conflicts of interest:

(commercial / non-commercial / industrial co-authorship)
SR: funding: national institute for health research via Cochrane infrastructure funding to the Cochrane bone, joint and muscle trauma group; conflicts of interest: Benjamin T Drew currently holds a NIHR/HEE Clinical Doctoral Fellowship grant.
A: not reported

B: not reported

Inclusion criteria SR:
- (quasi) randomised controlled trials evaluating knee orthoses for treating patellofemoral pain.
- subjectively reporting pain diagnosed by trial authors as 'patellofemoral pain syndrome',

'patellofemoral pain', 'anterior knee pain syndrome', 'patellar

dysfunction', 'chondromalacia patellae', 'patellar syndrome',

'patellofemoral syndrome' or 'chondropathy'.
- trials evaluating the use of a knee orthosis
- outcome: pain, functional outcomes, quality of life, impact on sporting or occupational participation, resource use/costs of intervention, participant satisfaction, complications of orthoses

Exclusion criteria SR:
- cross-over designs
- asymptomatic or non-pathological patients
- history of fracture, patellar dislocation, patellar tendinopathy, Hoffa’s syndrome, Osgood Schlatter syndrome, Sinding-Larsen-Johansson syndrome, iliotibial band friction syndrome, osteoarthritis rheumatoid arthritis, plica syndromes, or tibiofemoral injury or dysfunction
- trials reporting the use of orthoses following operative interventions
- mixed populations regarding knee pathology

5 studies included (2 relevant for this review)

Important patient characteristics at baseline:

Number of patients; characteristics important to the research question and/or for statistical adjustment (confounding in cohort studies); for example, age, sex, bmi,...

N, mean age

A: I: 41 patients, 42.2 (SD 15.3) yrs
 C: 45 patients, 41.0 (SD 9.3) yrs

B: Ia: 32 patients, 45 knees, 35 (SD11)
 Ib: 31 patients, 44 knees, 35 (SD9) yrs
 C: 34 patients, 44 knees, 35 (SD 11) yrs

Sex:

A: I: 15% Male
 C: 18% Male

B: not reported

Groups comparable at baseline?
not reported

Describe intervention:

A: knee sleeve + exercise therapy
knee sleeve: Altex Patellar

Knee support (Altex Patellar knee support AL-2285C), which is a neoprene sleeve with a patella cut-out.

This was worn whilst performing the exercises as well as during the day for the six-week study period.

The knee support was only removed at night for sleeping.
B-a: exercise and knee brace group
The brace was a Special FX Knee Brace (Generation II Orthotics, Inc, Richmond, BC). It has a Y-shaped inferior patellar buttress pad and an external

stabilisation strap to help control patellar movement

B-b: exercise and knee sleeve group
Knee sleeve constructed with same sleeve material as the patella brace. No hole was made in the sleeve over the patella

Describe control:

A: exercise therapy
Standardised protocol developed by a

physiotherapist. This consisted of isometric and isotonic programmes for quadriceps muscles, performed five times per week. All participants performed 10 repetitions per day for six weeks. All participants provided with an exercise sheet, outlining the programme.

B: exercise group
Structured home rehabilitation programme only. This structured home-rehabilitation programme consisted of a strengthening component, consisting of a 6- stage progression of 2-leg eccentric drop squats, then single leg lunges, and finally 1-leg eccentric drop

squats. The stretching component of the rehabilitation programme consisted of seated spinal rotations, supine hip external rotation, standing quadriceps stretch, and sitting hamstring stretch. Stretches were performed daily prior to and after the strengthening component of the programme. Each

stretch was performed passively 3 times, with each stretch held for 30 seconds

End-point of follow-up:

A: 6 weeks

B: 3, 6 and 12 weeks

For how many participants were no complete outcome data available?

(intervention/control)

A: Results section (page 102): "all patients completed the regular exercise program", therefore none appeared lost to follow-up

B: Separate participant flow not provided for individual groups. Thus group allocation of the 21 withdrawals and 2 cross-overs excluded from the analyses.

Outcome measure-1: pain

Pain during activity 0-10

Knee sleeve:

Effect measure: mean difference (95% CI):

A: -0.5 (-1.6, 0.6), 6 weeks

B: -0.1 (-1.58, 1.38), 12 weeks

Pooled effect (fixed effects model), inclusive Miller 1997:

-0.48 (95% CI -1.31 to 0.35) favoring sleeve

Heterogeneity (I²): 0%

Knee brace:

Effect measure: mean difference (95% CI):

B: -0.2 (-1.68, 1.28), 12 weeks

All braces:
Pooled effect (fixed effects model), inclusive Miller 1997:

-0.46 (95% CI -1.16 to 0.24) favoring brace

Heterogeneity (I²): 0%

All braces, B included with number of knee instead of number of patients
A: -0.5 (-1.6, 0.6), 6 weeks

Ba: -0.2 (-1.43, 1.03), 12 weeks
Bb: -0.1 (-1.33, 1.13), 12 weeks
Pooled effect (fixed effects model), inclusive Miller 1997:

-0.41 (95% CI -1.04 to 0.23) favoring brace

Heterogeneity (I²): 0%

Outcome measure-2, function
functional scores

Effect measure: std. mean difference (95% CI):

A: -0.08 (-0.5, 0.34), womac

Ba: -0.35 (-0.95, 0.24), knee function scale
Bb: -0.47 (-1.07, 0.13), knee function scale
Pooled effect (fixed effects model):

-0.25 (95% CI -0.55 to 0.05) favoring brace

Heterogeneity (I²): 0%

functional scores, B included with number of knee instead of number of patients

Effect measure: std. mean difference (95% CI):

A: -0.08 (-0.5, 0.34), womac

Ba: -0.35 (-0.85, 0.14), knee function scale
Bb: -0.47 (-0.97, 0.05), knee function scale
Pooled effect (fixed effects model):

-0.28 (95% CI -0.55 to -0.01) favoring brace

Heterogeneity (I²): 0%

Facultative:

Brief description of author’s conclusion: very low

quality evidence from clinically heterogeneous trials using different types of knee orthoses (knee brace, sleeve and strap) that using a

knee orthosis did not reduce knee pain or improve knee function in the short-term (under three months) in adults who were also undergoing an exercise programme for treating patellofemoral pain.

Risk of bias: regarding allocation, blinding, incomplete outcome data etc.

GRADE regarding VAS: very low (two levels risk of bias, one level downgraded indirectness)

GRADE regarding functional outcome: very low (two levels risk of bias, one level downgraded imprecision)

Insoles

Hossain, 2011

SR and meta-analysis of RCTs

Literature search up to March 2010

A: Collins, 2008

B: Wiener-Ogilvie, 2004

Study design:
A: RCT, parallel
B: RCT, parallel

Setting and Country:
A: single center within a community setting, Brisbane, Australia

B: single center trial in Winshaw, Lanarkshire, UK

Source of funding and conflicts of interest:

SR: Betsy Cadwaladr University health Board, Bangor, UK; University of Oxford, UK; University hospitals of Birmingham, UK; no conflicts of interest

A: not reported

B: not reported

Inclusion criteria SR:
- randomised or quasi-randomised studies
- skeletally mature adults)aged 18 years or over)
- at least one intervention arm where foot orthoses were compared with not treatment, placebo, analgesia or another orthotic device. Extended to included comparisons of foot orthoses plus another physical therapy intervention versus the same physical therapy intervention on its own and comparisons of foot orthoses versus another physical therapy intervention.
- outcome:
knee pain as quantified by VAS or other method; knee function used knee function score (e.g., WOMAC score, IKSS score); patient satisfaction; patient reported quality of life; use of analgesics/non-steroidal nati-inflammatory drugs; adverse events

Exclusion criteria SR:
- adolescents

3 studies included (2 relevant for current review)

Important patient characteristics at baseline:

N

A: I: 44
 C: 45

B: I: 10
 C: 10

age

A: not reported per group

B: I: 61.8 years
 C: 51 years

Sex:

A: not reported per group

B: not reported per group

Groups comparable at baseline?
not reported

Describe intervention:

A: foot orthoses + physiotherapy:
participants received both orthoses and physiotherapy and had an extra

appointment with the physiotherapist if necessary.

orthoses: received prefabricated, commercially available orthoses fitted to their shoes and customised,

if necessary, to optimise comfort through heat moulding and by adding wedge or heel raises.

The participants were advised to continue exercise and activities that did not provoke their pain.

The foot orthoses group were prescribed additional home exercise programme. Whereas this was prescribed to be performed bilaterally twice daily.

B: foot orthoses + exercises

Patients received supervised treatment over a 4 week period.

Patients receiving foot orthoses

were assessed by the podiatrist once a week for 3 weeks to check for the fitness of the orthoses. Patients were advised to continue to wear the orthoses and perform exercises on their own

accord after 4 weeks.

Foot orthoses group were provided with foot orthoses with a 40° rearfoot post. Rearfoot posts and forefoot posts were adjusted using 20° or 40° additional wedges, if necessary.

Describe control:

A: physiotherapy
physiotherapy consisted of patellar mobilisation, patellar taping, a progressive programme

of vasti muscle retraining exercises with electromyographic biofeedback, hamstring and anterior hip

stretches, hip external rotator retraining, and a home exercise programme.

The participants were advised to continue exercise and activities that did not provoke their pain.

B: exercises
Patients received supervised treatment over a 4 week period. Patients receiving the knee exercise regimen were seen twice a week for two weeks and then once a

week for a further two weeks by a physiotherapist (6 sessions in total).

Patients were advised to continue to perform exercises on their own

accord after 4 weeks.

exercise therapy:
• Isometric quadriceps contractions in full knee and hip extension.

• Isometric quadriceps contractions with hip slightly flexed and knee in full extension.

• Isotonic quadriceps contractions without resistance.

• Isotonic quadriceps contractions with resistance.

• Isotonic hamstring contractions.

• Dynamic stepping exercise.

• Hamstrings stretching exercises.

• Isometric hip adductors contractions.

• Dynamic side stepping.

End-point of follow-up:

A: 6, 12 and 52 weeks

B: 8 weeks

For how many participants were no complete outcome data available?

(intervention/control)

A: I: n=1, lost to follow-up
 C: n=3, lost to follow-up

B: I: n=1, drop out
 C: n=1, drop out due to injury

Outcome measure-1: pain

VAS (worst pain)

Effect measure: mean difference (95% CI):

A: -3.7 (-12.99, 5.59) (6 weeks)

A: -3.4 (-13.52. 6.75) (52 weeks)

No pooled effect calculated

F-36 pain scale (change scores at 8 weeks, positive scores = pain reduction)

Effect measure: mean difference (95% CI):

B: 9.6 (-8.99, 28.19)

Knee pain numbers with global improvement)

Effect measure: RR (95% CI):

8 weeks
A: 0.98 (0.86 – 1.11)

B: 1.33 (0.41, 4.33)

Pooled effect (fixed effects model):

1 (95% CI 0.86 to 1.17)

Heterogeneity (I²): 0%

52 weeks
A: 1.01 (0.82 – 1.23)

Outcome measure-2: function

Functional index questionnaire (FIQ)

Effect measure: mean difference (95% CI):

A: 0.4 (-0.59, 1.39) (6 weeks)

A: -0.4 (-1.51, 0.71) (52 weeks)

No pooled effect calculated

Knee function: anterior knee pain (Kujala anterior knee pain scale)
Effect measure: mean difference (95% CI):

A: 0.2 (-3.72, 4.12) (6 weeks)

A: 3.6 (-0.52, 7.72) (52 weeks)

No pooled effect calculated.

Facultative:

Brief description of author’s conclusion:
Though limited, the

available evidence does not reveal any clear advantage of foot orthoses over simple insoles or physiotherapy for PFJ pain

Included studies show risk of bias due to issues regarding blinding, selective reporting, similarity at baseline and equal treatment of different groups

Study

First author, year

Appropriate and clearly focused question?¹

Yes/no/unclear

Comprehensive and systematic literature search?²

Yes/no/unclear

Description of included and excluded studies?³

Yes/no/unclear

Description of relevant characteristics of included studies?⁴

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?⁵

Yes/no/unclear/notapplicable

Assessment of scientific quality of included studies?⁶

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?⁷

Yes/no/unclear

Potential risk of publication bias taken into account?⁸

Yes/no/unclear

Potential conflicts of interest reported?⁹

Yes/no/unclear

Taping

Callaghan, 2012

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

No

No

Bracing

Smith, 2015

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

Yes

No

Insoles

Hossain, 2011

Yes

Yes

Yes

Yes

Not applicable

Yes

Yes

Yes

No

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Taping

Arrebola, 2020

Sealed envelops

Unlikely

Likely

Likely

Unlikely

Unlikely

Likely

Unclear

Begum, 2020

Not reported

Unclear

Likely

Likely

Unlikely

Unlikely

Unclear

Likely

Ghourbanpour, 2018

Not reported

Unclear

Likely

Likely

Unclear

Unlikely

Unlikely

Unclear

Gunay, 2017

Computerized random numbers

Unclear

Likely

Likely

Unclear

Unlikely

Unclear

Unclear

Akbas, 2011

Random number generator

Unclear

Likely

Likely

Unclear

Unlikely

Unclear

Unclear

Bracing

Alsaharani, 2019

Simple randomization

Unclear

Likely

Likely

Unclear

Unlikely

Unclear

Likely

Uboldi, 2018

Not reported

Unclear

Likely

Likely

Unclear

Likely

Unlikely

Likely

Petersen, 2016

Not reported

Unclear

Likely

Likely

Unclear

Unlikely

Unlikely

Unclear