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. 2014 Oct 1;2014(10):CD011324. doi: 10.1002/14651858.CD011324

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
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
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
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
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