Leung 2008.
Methods |
Design: Parallel group, three‐arm, single‐blind randomised controlled trial (Hong Kong) Interventions: Continuous short wave diathermy plus stretching exercises or superficial heating (hot pack) plus stretching exercises or stretching exercises alone Sample size calculation: Not reported Analysis: Intention‐to‐treat analysis Source of funding: Not reported |
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Participants |
Number of participants: 30 (10 per group) Baseline characteristics: Duration of symptoms not reported Continuous short wave diathermy plus stretching exercises group: Mean (SD) age = 59.8 (12.87) years; Male:Female = 5:5 Hot pack plus stretching exercises group: Mean (SD) age = 62.5 (12.13) years; Male:Female = 2:8 Stretching exercises alone group: Mean (SD) age = 57.3 (13.1) years; Male:Female = 2:8 Inclusion criteria: 1. Experienced shoulder pain and limited shoulder movement for at least eight weeks Exclusion criteria: 1. History of trauma to the shoulder 2. Acute signs of inflammation over the shoulder 3. Intrinsic shoulder pathology 4. Taking analgesic or anti‐inflammatory drugs 5. Had metal implants 6. Impaired sensation of hot and cold 7. Pregnant 8. Had a cardiac pacemaker |
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Interventions | All participants received four stretching exercises in the following fixed sequence: stretching in external rotation, in flexion, followed by stretching in hand behind the back and cross‐body abduction. Participants were asked to repeat the stretches four times. Each stretch was sustained for 30 seconds, with 10 seconds rest between each stretch. The participants were asked to perform the stretching exercises at home every day for four weeks Continuous short wave diathermy (N=10) Components of intervention: A continuous shortwave diathermy machine (Curapuls 419, Enraf Nonius, the Netherlands) with an operating frequency of 27.12 MHz was used to deliver deep heating treatment. A pair of disc electrodes was placed on the anterior–posterior aspects of the affected glenohumeral joint, separated by a hand's‐breadth from the surface of the body. The intensity of the current was adjusted according to the participants' subjective feeling of comfortable warmth. If the level of perceived heating changed during the application, the machine's output was adjusted to maintain the sensation of comfortable warmth throughout the treatment Dosage: 20 minutes Frequency of administration: Three times a week for four weeks (12 sessions) Provider: Physiotherapist Hot pack (N=10) Components of intervention: An electrical hot pack sized 35.5 x 68.5 cm was used to deliver superficial heating. The temperature was set to 63 degrees Centigrade. The participants were informed that the only purpose of the heating was to produce a feeling of comfortable warmth. If they felt that the heat was excessive, the temperature of the electrical hot pack was adjusted immediately to ensure that the heat remained at a comfortably warm level only throughout the treatment Dosage: 20 minutes Frequency of administration: Three times a week for four weeks (12 sessions) Provider: Physiotherapist Stretching exercises only (N=10) See description of exercises above |
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Outcomes | Outcomes assessed before the intervention at sessions 6 (week 2) and 12 (end of 4 weeks treatment), and at four weeks post‐treatment cessation. No primary outcome was reported by the trialists 1. Shoulder score index, which combines self‐reported scores for pain (using a 10cm visual analogue scale) and function (using a 10‐item questionnaire addressing activities of daily living, each scored on a 4‐point ordinal scale of level of difficulty: 0=unable to do; 1=very difficult to do; 2=somewhat difficult; 3=not difficult). Both the pain and function score were weighted equally (50 points each) and combined for a total score of 100 points, which a higher score indicating better function. This combined score is calculated as (10 – VAS pain score) x 5 + (5/3 x cumulative activities of daily living score) 2. Range of motion in flexion, cross‐body adduction, external rotation with the arm by the side, external rotation with the arm in 90 degrees abduction, and hand‐behind‐back using a goniometer (not reported whether passive or active) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using an online randomization plane (http:/www.randomization.com)" Comment: An adequate method was used to generate the allocation sequence |
Allocation concealment (selection bias) | Unclear risk | Comment: No information about how the allocation sequence was concealed was reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "A single‐blinded, randomized controlled study was conducted. The rater was blinded to the group allocation" Comment: Given the nature of the interventions, participants were not blind to treatment, and may have had different expectations about the benefits of each intervention |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | High risk | Comment: Unblinded participants who may have had different expectations about the benefits of the intervention they received self‐reported pain and function |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "A single‐blinded, randomized controlled study was conducted. The rater was blinded to the group allocation" Comment: Assessors of range of motion were blind to treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "None of the participants in any of the treatment groups dropped out throughout the study period." Comment: Data for the complete sample of randomised participants was reported for each outcome |
Selective reporting (reporting bias) | Unclear risk | Comment: Outcome data was fully reported for all outcomes specified in the methods section of the publication, but it is unclear why pain and function sub‐scores of the shoulder index were not reported, and without a trial protocol it is unclear whether any other outcomes were measured but not reported based on the results |
Other bias | Low risk | Comment: No other sources of bias identified |