Lee 1973.
Methods |
Design: Parallel group, four‐arm randomised controlled trial (United Kingdom) Interventions: Infrared irradiation plus active exercises or intra‐articular injection of hydrocortisone acetate 25 mg (anterior approach, below the coracoid process) plus active exercises or intra‐articular injection of hydrocortisone acetate 25 mg into the synovial sheath surrounding the bicipital tendon of the bicipital groove of the humerus plus active exercises or analgesics only Sample size calculation: Not reported Analysis: Intention‐to‐treat analysis Source of funding: Not reported |
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Participants |
Number of participants: 80 (20 per group) Baseline characteristics: Age, sex, and duration of symptoms not reported Inclusion criteria: 1. Pain in the shoulder associated with limitation of passive movement of the shoulder joint Exclusion criteria: 1. Participants with a known cause of arthritis, bone or neurological disease, determined by full clinical, haematological, and radiographic examination |
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Interventions | All participants received a program of graduated active exercises according to the participants tolerance for six weeks. The exercises were divided into two categories: (1) Free active exercises, which were given to work the flexors and extensors of the shoulder joint, the abductors, and the medial and lateral rotators. A progression was followed using gravity, firstly to assist the movement, then with its effect eliminated, and finally with its effect resisting the action. The participants were asked to practice these exercises three times daily for 10 minutes each session, specifically in the morning, at midday, and in the evening; (2) Manual resistance, using proprioceptive neuromuscular facilitation techniques Infrared irradiation (N=20) Components of intervention: Infrared irradiation to both the anterior and posterior aspects of the shoulder region Dosage: 10 minutes Frequency of administration: Not reported Provider: Physiotherapist Intra‐articular injection of hydrocortisone acetate 25 mg (anterior approach, below the coracoid process) (N=20) Components of intervention: Intra‐articular injection of hydrocortisone acetate 25 mg (anterior approach, below the coracoid process) Dosage: N/A Frequency of administration: Not reported Provider: Rheumatologist Intra‐articular injection of hydrocortisone acetate 25 mg into the synovial sheath surrounding the bicipital tendon of the bicipital groove of the humerus (N=20) Components of intervention: Intra‐articular injection of hydrocortisone acetate 25 mg into the synovial sheath surrounding the bicipital tendon of the bicipital groove of the humerus Dosage: N/A Frequency of administration: Not reported Provider: Rheumatologist Analgesics (N=20) Components of intervention: Analgesics such as paracetamol, aspirin, codeine, or dihydrocodeine Dosage: As required Frequency of administration: Six weeks Provider: N/A |
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Outcomes | Outcomes assessed weekly for six weeks. No primary outcome was reported by the trialists 1. Range of motion (active abduction of the coronal plane, passive abduction of the coronal plane, active lateral rotation with the arm by the side, active medial rotation with the arm by the side) using a goniometer |
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Notes | Trialists reported that since there was high positive correlation between the four range of motion measures, component analysis was used to produce a single measure. The results of this measure were presented in Figure format as means with no measures of variation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Consecutive patients were allocated to one of the four treatment groups according to a randomised plan unknown to the referring clinician" Comment: No information on how the allocation sequence was generated was reported |
Allocation concealment (selection bias) | Unclear risk | Comment: No information on how the allocation sequence was concealed was reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Due to the nature of the trial it was impossible for it to be double blind in construction, but it was strictly controlled" 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) Objective outcomes | High risk | Quote: "Due to the nature of the trial it was impossible for it to be double blind in construction, but it was strictly controlled" Comment: Outcome assessors were not blind to treatment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: No dropouts, losses to follow‐up or exclusions were reported, but it was unclear whether the outcome data reported was based on the total number of randomised participants (as sample sizes were not reported in data tables) |
Selective reporting (reporting bias) | Unclear risk | Comment: Trialists reported that since there was high positive correlation between the four range of motion measures, component analysis was used to produce a single measure. The results of this measure were presented in Figure format as means with no measures of variation. However, it is not clear whether data were incompletely reported based on the statistical significance or magnitude of the results. Also, without a trial protocol, it is unclear whether other outcomes were assessed but not reported based on the results |
Other bias | Low risk | Comment: No other sources of bias identified |