Study reference

Study characteristics

Patient characteristics

Intervention

Control

Follow-up

Outcome measures and effect size

Comments

Crashaw (2010)

Study design:

Pragmatic randomised clinical trial simple block

randomisation

was performed for seven sites based on a computer generated

randomisation

list.

Setting and Country:

Leeds, London, UK

Source of funding and conflicts of interest:

The study was funded by a project grant 17236 from

Arthritis Research UK. No competing interests declared

by all authors.

Inclusion criteria

Adults aged 40 or over with subacromial impingement

syndrome who reported moderate

or severe shoulder

pain and were referred from primary care.

Exclusion criteria:

Not reported

N total at baseline: 232

Intervention: 117

Control: 115

Important prognostic factors²:

Mean age (year) total study population:

56 (range 40-78 years). Over half were woman. All had shoulder pain for a median of 16 weeks (IQR 12-28 weeks)

Groups comparable at baseline? Unknown

Describe intervention (treatment/procedure/test):

The group (n = 117; average duration of complaints 17 weeks, range 12-28 weeks) only received the combination of exercise therapy and manual therapy. The physiotherapist determined the duration of the treatment

treatment and chose which exercises or mobilization technique(s) were applied (from a list of 23 exercises/mobilization techniques).     

Describe control (treatment/procedure/test):

The group (n = 115) received a corticosteroid injection (20 mg triamcinolone acetonide + 4.5 ml 1% lidocaine) and a combination of exercise therapy and manual therapy (n = 115; average duration of complaints 14 weeks, range 10-26 weeks). The injection could be repeated after 6 weeks for moderate or severe pain.

Length of follow-up:

24 weeks

Loss-to-follow-up: not reported

Intervention:

N (%): 1

Reasons (describe)

Control:

N (%): 20

Reasons (describe)

Incomplete outcome data: not reported

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

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

6 weeks

Pain

Using the SPADI Pain subscale (0-100)

Mean:

I: 44.7

C: mean shoulder pain was 7.7. points less

MD: 7.7, 95% CI 4.5 to 11.0

Function

Using the SPADI subscale disability (0-100)

Mean

I: 36.1 points

C: 7.1 points more compared to the intervention group

MD: 7.1, 95% CI 4.0 to 10.1

Complications

No adverse events were reported in either group.

Risk of recurrence

Not reported

patient satisfaction

not reported

Return to work / active participation

Not reported

12 weeks

Pain

Using the SPADI Pain subscale (0-100)

Mean:

I: 38.7

C: mean shoulder pain was 3.8 points less

MD: 3.8, 95% CI -0.65 to 8.3

Function

Using the SPADI subscale disability (0-100)

Mean

I: 29.7 points

C: 2.9 points more compared to the I

MD: 2.9 (95% CI -1.1 to 6.9)

Complications

No adverse events were reported in either group.

Risk of recurrence

Not reported

patient satisfaction

not reported

Return to work / active participation

Not reported

Comments:

A corticosteroid injection prior to exercise therapy probably has a small, but

insignificant effect on shoulder pain and function after 6 weeks and no effect on pain and shoulder function after 12 weeks compared to exercise therapy without corticosteroid injection.

Trial registration number

ISRCTN 25817033;

Hajivandi (2021)  

Study design:

Randomized clinical trial study

Setting and Country:

patients who had complete rotator cuff rupture in the period of February 2017 to November 2016 were identified and enrolled in the study.

Patients were referred to the orthopedic clinic and assessed after signing the informed consent.

University of Iran

Source of funding and conflicts of interest:

Funding:

Conflict:

Inclusion criteria

patients with an age range of 30 to 70 years who were diagnosed with complete rotator cuff degenerative rupture with MRI and clinical examination and were consciously and cooperatively willing to participate in the study.

Exclusion criteria:

any concomitant shoulder disease such as infection, fracture, and tumor as well as trauma during treatment and therapeutic intervention by other people

N total at baseline: 96 patients

Intervention: 32

Control: 32

Another group is not included in this summery, in this group patients were solely provided steroids.

Important prognostic factors²:

For example

Mean age (year):

Gender

More than 80% of patients in each group were female.

I: 84.4% female

C: 81.3% female

Mean age

I: 51.78 ± 7.37

C: 50.87 ± 5.65

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

The first group underwent 12 sessions of physiotherapy in the form of massage, rotator cuff and scapular muscle stretching exercises, strengthening exercises and modalities including laser, transcutaneous electrical nerve stimulation (TENS), and ultrasound (US) twice a week for 6 weeks with a duration of 45 minutes per session including 30 minutes of electrotherapy and 15 minutes of manual therapy training.

Describe control (treatment/procedure/test):

The group was injected with 8 mg of methylprednisolone and 1 ml of lidocaine 2% and, two days later, underwent 6 sessions of physiotherapy by a rehabilitation specialist twice a week for 3 weeks. The duration of each session was 45 minutes, including 30 minutes of electrotherapy and 15 minutes of manual therapy training; after 6 sessions of physiotherapy at the end of the third week, the injection was performed, and the other 6 sessions of physiotherapy twice a week for 2 weeks were performed with a duration of 45 minutes per session.

All groups were instructed not to use NSAIDs or herbal and home remedies either orally or systemically or topically during the study.

Length of follow-up:

Not reported

Loss-to-follow-up: not reported

Intervention:

N (%):

Reasons (describe)

Control:

N (%):

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

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

Pain

Using the VAS:

Before intervention:

I: 5.53 ± 0.62

C: 5.59 ± 0.66

After intervention:

I: 4.00 ± 0.91

C: 3.56 ± 0.66

Function

Using the DASH:

Before intervention:

I: 57.21 ± 4.15

C: 56.77 ± 3.65

After intervention:

I: 48.77 ± 4.0

C: 45.91 ± 4.12

Complications

Not reported

Risk of recurrence

Not reported

Patient satisfaction

not reported

Return to work / active participation

Not reported

Comments:

This trial is registered with IRCT20200102045987N1.

Conclusion:

In the present study, despite the significant decrease in VAS and DASH scores in all three groups, no significant differences were observed between the two physiotherapy treatment approaches and CSI in the VAS and DASH scores. Instead, people who received both treatments showed significantly lower VAS as well as DASH scores than the other two groups.

Hsieh (2023)

Study design:

Prospective, three-arm randomised controlled trial

Setting and Country:

Patients with chronic subacromial bursitis were recruited from the department of Physical Medicine and Rehabilitation of the Shin Kong Wu Ho-Su Memorial Hospital. Trial was conducted from 1

 August 2018 through 31 July 2020.

Source of funding and conflicts of interest:

The study was financially supported by the National Science and Technology Council

 of Taiwan (no. NSTC 107-2314-B-341-002 and NSTC 108-2314-B-341-002).

Conflict:

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Inclusion criteria

Patients with chronic subacromial bursitis.

 (1) shoulder pain for more than 3 months, (2) age ≥20 years old, (3) pain on shoulder abduction or internal rotation with a pain visual analogue scale

 (VAS) score ≥4, (4) a painful arc of motion or pain on range of motion of shoulder (particularly abduction or internal rotation) with an empty or soft end feel, (5) positive shoulder impingement

 test (Neer’s test and/or Hawkin’s test) and (6) pain reduction ≥40% on active shoulder abduction or internal rotation at the terminal range after a

 diagnostic block (ultrasound-guided injection of 3 mL of 1% lidocaine into the subacromial

subdeltoid bursa).

Exclusion criteria:

(1) a history of

 Uncontrolled systemic diseases, for example,

 blood dyscrasia, malignant neoplasms, and serious infection; (2) previous fracture, dislocation or surgery of the affected shoulder; (3) evidence of

 a rotator cuff tear or tendinopathy, demonstrated by

 positive resistive tests and/or ultrasonographic findings; (4) calcification of the rotator cuff, demonstrated by X-ray or ultrasonographic findings; (5)

 the presence of arthritis (or >30% limitation of

 passive range of motion on shoulder abduction or

 external rotation) or instability of the affected shoulder; (6) the presence of cervical radiculopathy

 or myelopathy; and (7) having received a corticosteroid subacromial or shoulder joint injection in the past 3 months.

N total at baseline:

Patients were divided into corticosteroid injection (N=36), physiotherapy (N=40) and

 combined (N=35) groups. Two corticosteroid subdeltoid injections in corticosteroid group, 8-week phys

ical therapy emphasising on therapeutic exercise in physiotherapy group, and combined both treatments in

 combined group

total: 96 patients

Intervention: 28

Control: 32

Important prognostic factors²:

For example

Mean age (year):

I: 56.9 years

C: 54.2 years

Gender, Female

I: 25 (62%)

C: 23 (66%)

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

physical therapy (physiotherapy

 group); received 8-week physical

 therapy programme.

The physiotherapy programme consisted of hot pack, interferential therapy, and exercise programme, which includes stretch exercise, mobilisation of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilisation exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. Regarding scapular stabilisation exercise, the first step was guiding patients to find the scapular neutral position. It was the mid-position between their available range of scapular upward and down ward rotation, protraction and retraction, posterior

 and anterior tilt. Patients were instructed to maintain the neutral position by visual, auditory or kinaesthetic cues, and were consequently be taught to find the neutral position themselves. Patients were then asked to maintain scapular neutral position when doing shoulder flexion, abduction, internal and external rotation to the full range. Once scapular control was improved, resistance exercises of the rotator cuff and muscles related to scapular control (serratus anterior, middle and lower trapezius muscles, etc.) were added to the programme. The physiotherapy programme was supervised by a senior physical therapist and was conducted 3 times/week, for 8

 weeks.

Describe control (treatment/procedure/test):

corticosteroid injection and

 physiotherapy (combined group): received 8-week physical therapy programme and received 8-week physical therapy programme. I

If symptoms completely subsided

 after the first injection, the second injection was held.

2 mL triamcinolone (1 mL/10 mg) and 3 mL 1%xylocaine were injected into the affected subacromial-subdeltoid bursa under ultrasound guidance. The injection was administered with a

 22-gauze, 1.5-inch needle via a lateral approach with the patient sitting up. Injections were repeated after 2 weeks. Two injections with this interinjection interval were selected due to the size of the bursa and possibility of adhesions, requiring multiple injections. If patients were symptom-free after the first injection, no more injections would be given. All of the injections were administered by a senior physician who was a board-qualified physiatrist and ultrasonographer in musculoskeletal medicine.

Length of follow-up:

8 weeks

Loss-to-follow-up:

Intervention:

N (%): 1

Reasons (describe)

Control:

N (%): 20

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

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

8 weeks postop

Pain

using SPADI

I: 32.7 (22.4)

C: 37.5 (26.6)

VAS at rest

I: 13.1 (18.4)

C: 14.1 (21.5)

Function

using SPADI

I: 24.8 (21.7)

C: 28 (23.8)

Using WORC

I: 592.3 (485.7)

C: 647.4 (547.5)

Complications

Risk of recurrence

Recurrence of symptoms in 24 weeks, Yes

I: 3 (7%)

C: 6 (17%)

Patient satisfaction

Patients evaluation

I: 3.1 (1.7)

C: 3.7 (1.1)

Return to work / active participation

Not reported

Comments:

The study was registered on ClinicalTrials. gov (no. NCT03871465)

Conclusion:

Corticosteroid subdeltoid injection, or combined with physiotherapy, was superior to

 physiotherapy alone, but the recurrence rate was least in the physiotherapy group.

The pain VAS score,

 one of the commonly used measures of pain intensity, was obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating most imaginable pain.

The SPADI, a self-administered questionnaire used to assess the pain and disability associated with shoulder diseases,

 consists of 13 items that are divided into 2 subclasses, with 5 items for pain and 8 items for disabilities. The total SPADI score ranges between 0 and 100, with a higher score indicating a worse condition.

The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The final score ranges between 0 (no disability) and 100 (the worst situation). The minimal clinical important difference of SDQ is unknown.

Patient’s evaluation of the treatment effect

 included the answer to one question: ‘Is the treatment effective?’ scored on a Likert scale (very effective =1, effective=2, no change=3, worse =4, much worse=5).

Recurrence was defined as a new episode of

 moderate shoulder pain lasting more than 1 day following a period of at least 1 week pain free (pain intensity 0 or 1) or as an episode of care seeking for the same problem.

Raeeshi (2022)

Study design:

Double-blind, parallel Randomized Controlled Trial (RCT)

Setting and Country:

The trial was carried out in a primary care-based physiotherapy service run by specialist practitioners that treat patients with a range of musculoskeletal conditions – a physiotherapist specializing in shoulder conditions for more than five years. An orthopaedist undertook clinical assessments of recruited patients according to eligibility criteria. Patients with SAPS symptoms, recruited from various sources, were referred to an orthopaedic shoulder specialist to be identified whether they had the criteria to enter the study.

Source of funding and conflicts of interest:

Funding:

AcknowledgementThis study is part of MSc thesis of Mr. Javad Raeesi. Special thanks to Mashhad University of Medical Sciences (MUMS) for the support [Master thesis grant no: 981570]. Also, we acknowledge the staff of the Rehabilitation section of the Ghem Hospital, MUMS, IR; especially Mr Zarandi, who provided valuable assistance in sample collection. This work was supported by a MSc thesis grant from Mashhad University of Medical Sciences (MUMS), Mashhad, Iran [Master thesis grant no: 981570].

Conflict:

None of the authors has any financial or other interests relating to the manuscript to be submitted for publication in the Journal of Disability and Rehabilitation.

Inclusion criteria

(1) were Persian native speakers; (2) were aged 18–70; (3) Confirmed to have SAPS using the clinical cluster testing (more than three positive tests out of five): painful-arc motion during flexion or abduction, Hawkins-Kennedy test (shoulder elevation to 90 degrees, elbow flexed to 90 degrees, then passively internally rotate the humerus) , pain or weakness on resisted lateral rotation or abduction, Neer impingement test, and Empty can (Jobe) test, (4) have shoulder pain for more than 4 weeks, with the severity of more than three points (moderate or severe) based on the Visual Analog Scale (VAS). (corticosteroid injection is not routinely used for mild pain).

Exclusion criteria:

(1) Red flags as stated in the BESS guideline; (2) Previous shoulder surgery, dislocation, or fracture; (3) Bilateral shoulder pain, concomitant cervical radicular pain, or shoulder pain referred from the cervical spine that can be provoked by active neck movement; (4) Clinical signs of full-thickness rotator cuff tear; (5) Other shoulder disorders (e.g., frozen shoulder and/or severe degenerative joint disease); (6) Systematic pathologies including arthritis or neurological disease affecting the shoulder; (7) History of receiving corticosteroid injections or any physiotherapy intervention for shoulder pain within the last 6 months; (8) Contraindications to corticosteroid injection including pregnancy.

N total at baseline:

Intervention: 22

Control: 21

Important prognostic factors²:

For example

Mean age (SD):

I: 45.27 (13.09)

C: 50.62 (12.49)

Gender, Female (n, %)

I: 9 (41%)

C: 13 (62%)

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

Physiotherapy group with a program including an individually tailored exercise and manual therapy program prescribed and supervised by a physiotherapist, involving up to 12 face-to-face sessions over 4 weeks (n=25);

patients in the physiotherapy group started their program immediately after randomization. Both groups received a handout pamphlet about managing their symptomatic shoulder and were discouraged, but not prohibited, from seeking additional care during the study period.

Describe control (treatment/procedure/test):

Combined group with the same treatment program, preceded by corticosteroid injection (n=25).

The corticosteroid, composed of 1cc triamhexal mixed with 2cc lidocaine, was injected using an anterolateral approach with a 20mm needle (Sterican, B. Braun Melsungen AG) and a 5cc syringe.

Patients in the combined group received one landmark-guided injection in the shoulder subacromial bursa by an orthopedic surgeon. Patients were advised to take care of their shoulders and avoid heavy lifting for 48 hours post-injection. Patients in the combined group started their physiotherapy program between 4 and 7days after the injection. Both groups received a handout pamphlet about managing their symptomatic shoulder and were discouraged, but not prohibited, from seeking additional care during the study period.

Length of follow-up:

6 months

Loss-to-follow-up:

Intervention:

N (%): 1

Reasons (describe)

Control:

N (%): 20

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

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

3 months follow-up

Pain

Using the VAS (Mean, SD)

I: 3.05 (2.17)

C: 1.19 (1.36)

Cohen’s d: 1.02, 99% CI 0.35 to 3.35

Function

Using the SPADI

I: 21.79 (13.11)

C: 10.04 (10.49)

Cohen’s d: 0.98, 99% CI 1.92 to 21.55

Using the DASH

I: 23.33 (16.42)

C: 8.70 (9.55)

Cohen’s d: 1.08, 99% CI 3.48 to 25.76

Using the WORC

I: 19.24 (12.99)

C: 12.41 (12.01)

Cohen’s d: 0.54, 99% CI -3.48 to 17.15

6 months follow-up

Pain

Using the VAS (Mean, SD)

I: 2.23 (1.99)

C: 0.62 (0.59)

Cohen’s d: 1.08, 99% CI 0.35 to 3.35.

Function

Using the SPADI

I: 18.18 (16.93)

C: 6.87 (6.97)

Cohen’s d: 0,86, 99% CI 0.54 to 22.07

Using the DASH

I: 19.09 (18.90)

C: 4.26 (5.08)

Cohen’s d: 1.05, 99% CI 3.30 to 26.35

Using the WORC

I: 18.45 (15.70)

C: 6.57 (7.56)

Cohen’s d : 0.95, 99% CI 1.64 to 22.11.

Complications

Not reported

Risk of recurrence

Not reported

Patient satisfaction

not reported

Not reported

Return to work / active participation

Not reported

Not reported

Comments:

Trial registration number: IRCT20201010048980N1

Conclusion: In conclusion, evidence obtained from this study indicates that the effects of physiotherapy plus corticosteroid injection could be more clinically effective and long-lasting than physiotherapy alone in improving pain intensity, disability, quality of life, and treatment effectiveness in patients with SAPS in the medium-term.

The pain intensity was assessed using a Visual Analog Scale (VAS). Patients were asked to determine their pain intensity on a 0–10 points scale in which 0 indicates no pain and 10 indicates the most severe pain experienced.

Disability was assessed using two self-reported questionnaires: The Shortened Disability of the Arm, Shoulder, and Hand (Quick- DASH) questionnaire and the Shoulder Pain and Disability Index (SPADI). The Quick-DASH, which its Persian version has been validated to use in Iran (with a 0.89 ICC score), comprises 11 items that measure upper limb physical disabilities and symptoms. Final scores range from 0 to 100 (“no disability” to “completely disabled”). The SPADI is a 0 to 100-point, 13-item, self-administered questionnaire (lesser scores express poor outcomes) divided into two subscales: a 5-item pain subscale and an 8-item disability subscale. The Persian version of SPADI has been validated to use in Iran and has adequate responsiveness to clinical changes in shoulder disorders [33]. Our primary outcome was SPADI due to prior sample sizing calculation on disability.

Cohen's d of 0.2, 0.5, 0.8 are considered small, medium and large effect sizes respectively

ElGendy (2023)

Study design:

This study was a three-arm parallel-group, assessor, and

 patient-blinded, randomized controlled trial.

Setting and Country:

This study was performed at the physical therapy outpatient

 clinic of El-Safa General Hospital, Damietta, Egypt, between September 2019 and October 2021.

Source of funding and conflicts of interest:

Funding:

Conflict:

Financial disclosure statements have been obtained, and no conflicts of interest have

 been reported by the authors or by any individuals in control of the content of this article.

Inclusion criteria

To be eligible, the individual should present SIS for more than 3 mos without signs of chronic

 inflammation or shoulder degeneration. The included patients

 were diagnosed by an orthopedist with a stage II Neer classification

of unilateral SIS. Two or more of the following provocative

 tests for SIS were positive in the patients: Neer test, painful arc test, Hawkins-Kennedy test, and external rotation test.

Exclusion criteria:

Patients were excluded from the study if they had a body mass index >30 kg/m2, frozen shoulders, rheumatoid arthritis, arthritis of the shoulder, shoulder instability, previous shoulder surgery or trauma, history of dislocation/subluxation of the shoulder, fracture of the shoulder girdle, congenital anomalies

 or internal metallic fixation of the shoulder, gout, cervical

 radiculopathy, full-thickness tear of the rotator cuff, neurologic

 or systemic diseases (as diabetes mellitus), previous LCI or ESWT of the shoulder, systemic lupus erythematosus, radiotherapy to shoulder, tumor of the shoulder, pacemaker, and physiotherapeutic shoulder treatment within the last 3 mos.

N total at baseline: 60

Intervention: 20

Control: 20

Important prognostic factors²:

For example

Mean age (year):

I: 32.72 ± 4.38

C: 30.47 ± 3.69

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Participants in group B received CPT programs only

Describe control (treatment/procedure/test):

Participants allocated to group A received a CPT program for SIS three times per week for 4 wks, plus a dose of LCI applied in the first week of the exercise program. A trained orthopedist applied 40 mg triamcinolone acetonide plus 1% xylocaine to the subacromial space using the posterior approach. The physiotherapy program included shoulder mobilizations, scapular muscle exercises, and rotator cuff strengthening exercises

Length of follow-up:

Up to 12 weeks

Loss-to-follow-up:

Not reported, solely that ‘’63 were randomized to receive the interventions and 60 completed both follow-ups at 4 and 12 wks’’

Intervention:

N (%): 1

Reasons (describe)

Control:

N (%): 20

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

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

4 weeks

Pain

SPADI (0-100), mean ± SD

I: 30.09 ± 19.61

C: 23.28 ± 11.86

Function

Not reported

Complications

Not reported

Risk of recurrence

Not reported

Patient satisfaction

Not reported

Return to work / active participation

Not reported

12 weeks

Pain

SPADI (0-100), mean ± SD

I: 32.23 ± 19.88

C: 22.39 ± 11.08

Function

Not reported

Complications

Not reported

Risk of recurrence

Not reported

Patient satisfaction

Not reported

Return to work / active participation

Not reported

Comments:

The protocol of this study

 was prospectively registered at Pan African Clinical Trial Registry (PACTR201910650013453).

Conclusion: The addition of extracorporeal shock wave therapy to CPT (conventional physiotherapy) induced more noticeable intermediate-term effects than CPT plus

 local corticosteroid injection or CPT alone.

The SPADI is a self-reported, planned, reliable, and valid questionnaire, which contains 13 questions assigned to a five-item pain domain and an eight-item disability domain. Each item was scored on a visual analog scale from

 0 (no problem) to 10 (worst difficulty or pain). The total sum score varies from 0 to 100 (with a higher score indicating greater glenohumeral joint pain and disability).

The physiotherapist responsible for the CPT program asked the participants about the presence of undesired effects such as transient pain, swelling and bruising at the site of application,

 and surface skin redness.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Hajivandi, 2021  

Probably yes

Reason:

Reported in text: ‘’A total of 96 patients were randomly assigned to the study and divided into 3 groups of 32 patients’’

Probably no

Reason:

Concealment of allocation not reported.

Probably no

Reason:

Blinding not reported.

Probably yes

Reason:

Loss to follow-up not reported

Definitely yes

Reason:

All outcome measures reported

Probably yes

Reason:

No other problems noted

Some concerns of bias

Hsieh (2023)

Definitely yes

Reason:

Groups were composed after randomization; The assignment scheme was generated using

 a table of computer-generated random numbers, which was placed into opaque, sealed envelopes. Each patient was allocated to one of the treatment groups according to the randomisation sequence.

Definitely yes

Reason:

Groups were composed after randomization; The assignment scheme was generated using

 a table of computer-generated random numbers,

 which was placed into opaque, sealed envelopes. Each patient was allocated to one of the treatment

 groups according to the randomisation sequence.

Probably yes

Reason:

Solely reported that the outcome assessor was blind to the treatment assignment.

Probably yes;

Reason:

Loss to follow up was not reported overall, however numbers were presented regarding loss to follow up at 28 weeks post intervention when measuring recurrence. In text referred as ‘’Third, a high percentage of loss to follow up in the physiotherapy group might inter fere with data analysis.’’

Definitely yes

Reason:

All outcome measures reported

Probably yes

Reason:

No other problems noted

Low concerns of bias

Raeesi (2022)

Definitely yes

Reason:

patients’ baseline assessment (pre-test outcome) was gathered, and then they were randomly allocated (1:1) to either the combined (physiotherapy plus corticosteroid injection) group or the physiotherapy group to start their intervention protocol.

An independent practitioner randomized patients with a simple, balanced process into two intervention groups using sequentially numbered cards (a computer software program generated sequential numbers) sealed in opaque envelopes to ensure concealed allocation.

Definitely yes

Reason:

An independent practitioner randomized patients with a simple, balanced process into two intervention groups using sequentially numbered cards (a computer software program generated sequential numbers) sealed in opaque envelopes to ensure concealed allocation.

Probably yes

Reason:

Since both intervention programs are prescribed routinely in SAPS’s treatment protocol, patients’ blinding would not violate ethics. However, although each group received intervention on different days (a group on odd days and another on even days) to reduce the biased effect of being acknowledged about having corticosteroid injection or not, the study’s patients were not assessed regarding their blinding, and we cannot completely support our patients’ blinding. The physiotherapist delivering the intervention was not blind to the treatment allocation due to the different treatment methods (Corticosteroid injection in the combined group), but the trial assessor and statistician were blinded to the treatment allocation throughout the study period. Therefore, this study can be considered a double-blind clinical trial with the trial assessor and statistician blinding.

Probably yes

Reason:

Loss to follow up not reported

Definitely yes

Reason:

All outcome measures reported

Probably yes

Reason:

No other problems noted

Some concerns of bias

ElGendy (2023)

Definitely yes

Reason;

An independent physiotherapist (not involved in the trial application and not informed of the study protocol) built a computer list that was used for the randomly allocated sequence in a 1:1 ratio. The physiotherapist placed the names of the patients in closed envelopes to confirm allocation concealment.

 Each envelope was opened by a nurse before the first treatment session. Patients were randomly assigned to receive conventional

 physiotherapy plus LCI (group A, n = 20), conventional physiotherapy alone (group B, n = 20), or conventional physiotherapy plus ESWT (group C, n = 20).

Definitely yes

Reason;

An independent physiotherapist (not involved in the trial application and not informed of the study protocol) built a computer list that was used for the randomly allocated sequence in a 1:1 ratio. The physiotherapist placed the names of the patients in closed envelopes to confirm allocation concealment.

 Each envelope was opened by a nurse before the first treatment session. Patients were randomly assigned to receive conventional

 physiotherapy plus LCI (group A, n = 20), conventional physiotherapy alone (group B, n = 20), or conventional physiotherapy plus ESWT (group C, n = 20).

Probably yes

Reason:

Patients were blinded before assignment to their corresponding groups (i.e., the patients were not aware of the interventional procedures of all groups). The assessor responsible for evaluating the participants’ outcomes was also unaware of the participants’ group allocation.

Probably yes

Reason:

Loss to follow-up occurred minimally

Definitely yes

Reason:

All outcome measures reported

Probably yes

Reason:

No other problems noted

Low concerns of bias