Authors
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Rangan, Amar -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2014
INTERVENTION: Participants will be randomly allocated into one of three groups: 1. Evidence based, early structured physiotherapy (ESP) for 12 weeks (' active control') based on national clinical guidelines for management of frozen shoulder. Core elements of this are education, reassurance and advice; instruction on exercises from gentle active, gentle pendular movements in comfortable range to stretches of the tightened capsule augmented by hands‐on mobilisation techniques, applied by the physiotherapist and intra‐articular (into the joint) steroid injection is a core option for pain relief. 2. Manipulation under anaesthesia (MUA) without arthroscopic capsular release (ACR) within 18 weeks from randomisation. This is a day case procedure which involves controlled manipulation of the affected shoulder whilst the patient is under general anaesthesia. The manipulation stretches and tears the tight capsule restoring range of motion to the shoulder. This is not preceded by any formal surgical release of the tight structures. Steroid injection into the joint is provided for pain relief. 3. Manipulation under anaesthesia (MUA) with arthroscopic capsular release (ACR) within 18 weeks from randomisation. This typically is done as a day case procedure, where the contracted and tight shoulder capsule is released using arthroscopic (keyhole) techniques, followed by manipulation to confirm restoration of range of motion in the shoulder. Steroid injection is generally avoided following key hole surgery, as the risk of infection is increased in the presence of steroid. Alternative methods of pain relief, which are part of usual care following ACR, will be provided. Additional procedures like posterior capsular release, subacromial decompression and supplementary steroid injections for pain control occur in a minority of patients and will be left pragmatic as a needs based intervention. Following MUA or ACR, patients will undergo a further 12‐week programme of physiotherapy, normally comm CONDITION: Frozen shoulder (adhesive capsulitis) ; Musculoskeletal Diseases ; Adhesive capsulitis of shoulder PRIMARY OUTCOME: Oxford Shoulder Score (OSS) (12‐item condition‐specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 3, 6 and 12 months post randomisation. Primary time point is 12 months after randomisation. OSS will also be collected at pre‐treatment, as well as 6 months post‐treatment INCLUSION CRITERIA: 1. Patients with frozen shoulder, including diabetics, >=18 years old 2. Passive external rotation in the affected shoulder that is <50% of the contralateral shoulder 3. Radiographs to exclude secondary causes e.g. glenohumeral arthritis SECONDARY OUTCOME: 1. Disabilities of Arm Shoulder and Hand (DASH) ‐ The QuickDASH will be measured at baseline, 3, 6 and 12 months. ; 2. Medical Outcomes Study Short Form 36‐item questionnaire (MOS SF‐36) to assess health related quality of life ‐ will be collected at baseline, 3, 6 and 12 months.; 3. The EQ5D‐5L, generic and health economic self‐complete patient‐reported outcome measure ‐ will be collected at baseline, 3, 6 and 12 months.; 4. Pain measured using the Numeric Rating Scale for pain ‐ will be collected at baseline, 3, 6 and 12 months.; 5. Time to resolution‐ a simple subjective global question to be administered at baseline, 3, 6 and 12 months; 6. Complications ‐ All complications will be recorded at 12 months; 7. Adverse events‐ will be collected over 12 months; 8. The economic evaluation to determine the relative cost‐effectiveness of three interventions for the treatment of frozen shoulder‐ at baseline, 3, 6 and 12 months; 9. Qualitative study (Up to 45 patients and 10 to 15 health care professionals) ‐ at 12 months
Epistemonikos ID: b4f6af7fa8bd372b34869a4e2b28910a0257c3fd
First added on: Aug 23, 2024