Calis 2006.
Methods |
Design: Parallel group, four‐arm randomised controlled trial (Turkey) Interventions: Electrotherapy modalities (ultrasound, transcutaneous electrical nerve stimulation) plus hot pack plus exercises or sodium hyaluronate injection plus exercises or triamsinolone acetonide injection plus exercises or 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: 90 (21, 24, 25 and 20 in each respective group) Baseline characteristics: Duration of symptoms was not reported Electrotherapy modalities (ultrasound, TENS) plus hot pack group: Mean (SD) age = 52.33 (10.1) years; Male:Female = 8:13 Sodium hyaluronate injection group: Mean (SD) age = 59.7 (9.81) years; Male:Female = 10:14 Triamsinolone acetonide injection group: Mean (SD) age = 56.36 (11.3) years; Male:Female = 9:16 Stretching and Codman exercises alone group: Mean (SD) age = 59.25 (6.8) years; Male:Female = 6:14 Inclusion criteria: 1. At least a one‐month history of pain 2. Limited active and passive shoulder movement 3. 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 4. No previous injection in the involved shoulder 5. No history of allergy to local anaesthetics, steroids or sodium hyaluronate 6. Absence of coagulation disease 7. Absence of cervical radiculopathy, fracture, dislocation, and rotator cuff laceration 8. Absence of hematological, infectious, endocrine, neurological, and malignant disease, severe osteoporosis, cardiovascular disease, hepatic, and renal disorders 9. Subacromial impingement injection test negativity Exclusion criteria: See inclusion criteria |
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Interventions | All groups were recommended stretching and Codman exercises to do at home for two weeks Electrotherapy modalities (ultrasound, TENS) plus hot pack group (N=21) Components of intervention: ‐ Electrotherapy: Ultrasonic therapy at 1.5 W/cm2, and TENS at the patient’s tolerance ‐ Other: hot pack Dosage: ‐ Electrotherapy: Ultrasonic therapy for five minutes; TENS for 20 minutes ‐ Hot pack: 20 minutes Frequency of administration: Daily for 10 days (10 sessions) Provider: Physiatrist Sodium hyaluronate injection (N=24) Components of intervention: Sodium hyaluronate 30 mg (Orthovisc 30 mg) was injected into the shoulder joint by the posterior approach. The injection was done with a 22‐gauge needle as follows: while the participant was sitting, the index finger of the operator's free hand was placed on the tip of the coracoid process with the thumb at the angle of the acromion and the spine of the scapula. The needle punctured the skin near operator's thumb and was aimed just laterally to the tip of the index finger Dosage: N/A Frequency of administration: Once a week for two weeks Provider: Rheumatologist Triamsinolone acetonide injection (N=25) Components of intervention: A 40 mg dose of triamsinolone asetonide (Kenakort‐A) was injected into the shoulder joint by the posterior approach. The injection was done with a 22‐gauge needle as follows: while the participant was sitting, the index finger of the operator's free hand was placed on the tip of the coracoid process with the thumb at the angle of the acromion and the spine of the scapula. The needle punctured the skin near operator's thumb and was aimed just laterally to the tip of the index finger Dosage: N/A Frequency of administration: Once Provider: Rheumatologist Stretching and Codman exercises alone (N=20) |
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Outcomes | Outcomes assessed at baseline, day 15, and the third month after the initial visit. No primary outcome was reported by the trialists 1. Pain using a horizontal visual analogue scale (scale units not reported) 2. Passive range of motion in abduction and external rotation using a goniometry 3. Constant score (0‐100 scale where a higher score indicates better functional ability) |
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Notes | One participant in the electrotherapy modalities group, three in the sodium hyaluronate injection group, and one in the triamsinolone asetonide injection group had bilateral adhesive capsulitis and contributed both shoulders to the trial. The unit of analysis reported was shoulders, not participants. Trialists did not report adjusting for the bilateral involvement, or how bilateral shoulders were randomised (i.e. whether both shoulders received the same or different interventions is unclear). As a conservative estimate of the treatment effect, we entered the number of participants per group as the sample sizes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated to one of the four treatment groups" Comment: No information about how the allocation sequence was generated was reported |
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 | 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 some components of the Constant score |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "The same specialist (MC) determined the diagnosis and treatment protocol in all patients. All the patients were evaluated by another physiatrist (SU) who was blinded to groups" Comment: The outcome assessor of range of motion was blind to treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: No dropouts or losses to follow‐up reported, and the analyses are reported as being based on the total number of randomised shoulders |
Selective reporting (reporting bias) | Unclear risk | Comment: No numerical outcome data was reported for pain. Instead, mean endpoint values (with no measures of variation) were presented in Figure format. 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 |