adhesive capsulitis frozen shoulder
Conditions
Interventions
MUA: Manipulation under anaesthesia is performed by the orthopaedic surgeon at
the recovery room under locoregional anesthesia. If necessary or desired by the
patient, general anesthesia can be adde
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age between 18 and 70 years - Clinical signs of frozen shoulder in phase two being: - Symptoms of pain and stiffness, predominantly in one shoulder, persisting >= 3 months, without preliminary trauma which led to an anatomic abnormality. Characteristically, the pain is most severe at the end of the range of motion. Pain must be diminished compared to the maximum amount of pain in phase one of the condition. - Restriction of passive motion in the glenohumeral joint of >=30° in external rotation and at least a second plane of movement with >=30°restriction (compared to the contralateral side) - Unsuccessful conservative therapy within the previous 3 months
Exclusion criteria
Exclusion criteria: • Numeric Pain Rating Scale at rest >= 7 • Onset of complaints >= 1 year ago • Osteoarthritis of the glenohumeral or acromioclavicular joint, Kellgren-Lawrence osteoarthritis grading scale >= 2 • Previous surgery to the shoulder • Systemic inflammatory joint disease • Evidence of a complete rotator cuff tear on physical examination, ultrasound images or MRI • Neurological disorders upper limb • Therapeutic anticoagulation which can not be interrupted without bridging therapy • Other known shoulder pathology such as infection or tumor • Contra-indication to corticosteroid injection, allergy to contrast or local anaesthetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome parameter/endpoint The main outcome parameter functional outcome, measured by the SPADI at one month. A self-reporting questionnaire which consist of 13 questions divided in two domains: pain (5 items) and disability (8 items). Item responses are responded on a ten point scale. A total SPADI score is calculated by summing and then averaging the 2 subscales. This leads to a score between 0 (best) and 100 (worst). (Roach 1991) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome scores are SPADI at the remainder of follow up moments. The Oxford Shoulder Score. Pain at rest and during activity (Numeric Pain Rating Score). Health related quality of life (EQ-5D). Range of motion. Two PROMS anchor questions regarding the change in pain and in daily functioning, WORQ-UP, single item work ability score and absenteeism last month. The Oxford Shoulder Score is a patient reported outcome measure, which consist of 12 questions related to pain and function of the arm in daily life. Items are responded on a one to five point scale. An OSS is calculated by summing, this leads to a score between 12 (best) and 60 (worst).18 The Numeric Pain Rating Score is a validated ten-point visual analogue score to asses pain which represents a valid measure of acute pain with a good construct validity. The NPRS ranges from zero to ten, in which zero expresses no pain and ten expresses the worst pain possible. The EQ-5D is a standardised health questionnaire scoring on five domains: mobility, self-care, usual activities, pain/discomfort, anxiety and depression. It includes also the EQ-vas, a linear scale from 0 to 100 on which patients rate their health state. Two anchor questions will be asked regarding the amount of change that is experienced since the start of treatment considering pain and daily functioning. This is reported on a seven-point scale. These questions are based on an advice to use them from the division shoulder and elbow from the Dutch Orthopaedic Society. Passive Range of Motion (ROM) is measured by a goniometer. Forward flexion and abduction in the standing position, external rotation measured with the arm held against the chest and the elbow in 90° flexion. Internal rotation is estimated to which height the patient can reach on his back, appointed to the highest vertebral level of the wrist. The ability to work is evaluated by a combination of questionnaires. Single item work ability Index is a single | — |
Countries
Netherlands
Outcome results
None listed