Leclaire 1991.
Methods |
Design: Parallel group, two‐arm, triple blind randomised controlled trial (Canada) Interventions: Pulsed electromagnetic field therapy (PEMF) plus hot pack applications plus passive manual stretching and pulley exercises or placebo electromagnetic field therapy plus hot pack applications plus passive manual stretching and pulley exercises Sample size calculation: Trialists reported that "…the power of this study was 90% to show a change of 37 degrees in mean total range of motion recorded for the placebo group" (pg 286). However, this was reported in the Discussion section and could be a post hoc power calculation Analysis: Intention‐to‐treat analysis Source of funding: Not reported |
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Participants |
Number of participants: 47 (22 and 25 in each respective group) Baseline characteristics: Baseline characteristics by group were not reported Mean (SD) age = 58 (6.9) years; Male:Female = 18:29 Mean (SD) duration of symptoms = 17 (4.1) weeks Inclusion criteria: 1. Shoulder pain for more than two months 2. Limited active and passive shoulder movement 3. Pain on resisted abduction, internal and external rotation, and impaired glenohumeral joint motion 4. Decreased passive range of motion of 20% or more, in at least three movements, according to the American Medical Association guide for the evaluation of permanent impairment, i.e. flexion <144 degrees, extension <32 degrees, abduction <120 degrees, adduction <24 degrees, external rotation <72 degrees, and internal rotation <32 degrees Exclusion criteria: 1. Have arthritis, bone or neurologic disease, unstable heart disease, or haemostatic disorder 2. Have rotator cuff rupture, x‐ray calcification >2mm, or severe adhesive capsulitis defined as a limitation of flexion to 100 degrees, abduction to 90 degrees, or global rotations by 20 degrees or more 3. Currently receiving anticoagulants or anti‐inflammatory drugs, or have received steroid injection in the shoulder previously |
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Interventions |
Pulsed electromagnetic field therapy (PEMF) plus hot pack plus exercise (N=22) Components of intervention: ‐ PEMF: The schedule was: 30 Gauss, 10 Hz for sessions 1 to 6; 40 Gauss, 15 Hz for sessions 7 to 16; and 60 Gauss, 30 Hz for sessions 17 and beyond ‐ Hot pack ‐ Supervised exercise: Passive glenohumeral joint stretching exercises to the participants tolerance plus standardised pulley exercises ‐ Home exercise: Active non‐assisted exercises using a wooden stick Dosage: ‐ PEMF: 30 minutes ‐ Hot pack: 30 minutes ‐ Supervised exercise: 5 minutes (stretching) and 10 minutes (pulley) ‐ Home exercise: 20 minutes Frequency of administration: Three times a week up to a maximum of 12 weeks (36 sessions); home exercises only conducted on the days in which physical therapy was not received Provider: Not reported Placebo electromagnetic field therapy (N=25) Participants received the same interventions as described above except that placebo electromagnetic field therapy was applied |
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Outcomes | Outcomes assessed weekly for 12 weeks. No primary outcome was reported by the trialists 1. Range of motion in flexion, extension, abduction, adduction, external rotation, internal rotation measured at week 4, 8 and 12 (not reported whether passive or active) 2. Pain intensity at rest, on motion, and lying down, using a 4‐point ordinal scale rated as 1=absence of pain, 2=light pain, 3=moderate pain, and 4=severe pain 3. Pain intensity using a 100mm visual analogue scale 4. Disability (interference with daily activities) using a 100mm visual analogue scale 5. Adverse events |
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Notes | Trialists did not report any outcome data for VAS pain and VAS disability. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Consenting participants were then randomised". Comment: No information on how the allocation sequence was generated was reported |
Allocation concealment (selection bias) | Unclear risk | Quote: "A separate individual was provided the randomization code and controlled the concealed switch." Comment: No information on how the allocation sequence was concealed was reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The study used a triple‐blind parallel group design. Subjects received either (1) electromagnetic field therapy or sham therapy…The patient, therapist, and investigator were blind to the procedure. A separate individual was provided the randomization code and controlled the concealed switch." Comment: Participants and personnel were blind to treatment |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Quote: "The patient, therapist, and investigator were blind to the procedure." Comment: Blinded participants self‐reported pain and disability |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "The patient, therapist, and investigator were blind to the procedure." Comment: Range of motion was assessed by blinded a outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "…and all completed the study according to the protocol." Comment: There were no dropouts, exclusions, or losses to follow‐up |
Selective reporting (reporting bias) | High risk | Comment: Outcome data was fully reported for all outcomes specified in the methods section of the publication, except for VAS pain and VAS disability (which appear to have been incompletely reported because there was no statistically significant difference between groups on these outcomes). Also, without a trial protocol it is unclear whether other outcomes were measured but not reported based on the results |
Other bias | Low risk | Comment: No other sources of bias identified |