None listed
Conditions
Brief summary
Frozen shoulder is a condition which involves pain and stiffness of the shoulder joint and is often associated with a significant restriction of arm function and quality of life or well-being. We would like to see whether there are treatments that are better at reducing pain and improving the stiffness than our current treatments. The current treatment approach is called a “glenohumeral joint corticosteroid injection”. The glenohumeral joint is the shoulder joint capsule. It involves an injection of a steroid medication and a local anaesthetic agent into the shoulder joint capsule. Physiotherapy exercises are then given. It is thought that the steroid reduces the inflammation and pain around the shoulder joint which then allows the shoulder to be moved more easily with physiotherapy exercises. The newer approach we want to test is called “supra-scapular nerve block”. This has been shown to be safe and helpful in reducing pain for people with other types of shoulder problems. The treatment involves an injection of a steroid medication and a local anaesthetic agent into the tissues over the shoulder blade. This injection temporarily blocks the supra-scapular nerve which transmits the pain associated with frozen shoulder. Like the current treatment approach, once the pain has been reduced it should be easier to get the shoulder moving again with physiotherapy exercises. It is possible to repeat the suprascapular nerve block up to 4 times, at 3 monthly intervals, if the pain and stiffness remain. We think that the rate of recovery from frozen shoulder might be faster when current treatment and repeated supra-scapular nerve blocks are done together. In order to test this, participants will be randomly placed into one of two groups. One group will receive the supra-scapular nerve block injection and the other group will receive the placebo (saline) injection. These injections may be performed up to 4 times over the course of 1 year. In addition to receiving either the supra-scapular nerve block or the placebo injection, participants will receive the current best treatment available (glenohumeral joint injection and physiotherapy). Baseline information will be collected including age, general medical health, current medications, duration of shoulder symptoms, severity of shoulder symptoms and previous treatment for shoulder symptoms. Measures of shoulder range of motion, participant’s pain scores and levels of satisfaction will be measured at 3, 6, 9, 12, 18 and 24 months in order to compare both treatment approaches.
Interventions
Randomised, double blind, placebo controlled trial to evaluate the benefit of adding supra-scapular nerve block to an evidence informed management regime (intra-articular corticosteroid injection plus physiotherapy and oral analgesia as appropriate) for the adhesive capsulitis.
Standard care:
1. Patient education (verbal format) detailing the pathology and self limiting nature of adhesive capsulitis.
2. An initial single delivery Gleno-humeral joint (intra-articular space) injection (20 mg Tr
Randomised, double blind, placebo controlled trial to evaluate the benefit of adding supra-scapular nerve block to an evidence informed management regime (intra-articular corticosteroid injection plus physiotherapy and oral analgesia as appropriate) for the adhesive capsulitis. Standard care: 1. Patient education (verbal format) detailing the pathology and self limiting nature of adhesive capsulitis. 2. An initial single delivery Gleno-humeral joint (intra-articular space) injection (20 mg Triamcinolone acetonide (0.5 ml Kenalog) and 1.5 ml 2% Lidocaine Hydrochloride (Xylocaine)). 3. Physiotherapy intervention including passive shoulder mobilization (20 min sessions, 2 x week, first 3 weeks, then 1 x week, following 3 weeks) and a twice daily 20 min self mobilization program. Physiotherapy program to be repeated with subsequent supra-scapular nerve blocks (up to 4 over a 12 month period). Active arm: Supra-scapular nerve block injection (10ml of 0.5% bupivacaine and 40mg of methylprednisolone) administered by the principal investigator (Rheumatologist) as described by Dangoisse et al (1994). Repeated at 3 monthly intervals over 12 months, should any or all of the following criteria be met: 1. A Patient Perceived Rate of Recovery of less than "good to very good Improved" on the 5 point ordinal scale (including the response categories ‘‘worse’’, ‘‘unchanged’’, ‘‘unsatisfactory improved’’, ‘‘satisfactory improved’’ and ‘‘good to very good improved’’) 2. A self-assessment of ongoing pain greater than 1/10 on the visual analogue scale 3. An ongoing deficit of more than 20% of expected full active shoulder range of motion, as determined by the un-involved or contralateral shoulder range of motion. Adherence will be monitored using the following methods: 1. The principal investigator will record (log) the date of initial and subsequent active or placebo injections 2. The metrologist will record outcome measures at 3, 6, 9, 12, 18 and 24 months. 3. The physiotherapist will record (log) the participant's attendance 4. The participant will record (log) adherence with the home mobilisation program
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with progressive shoulder pain and stiffness in predominantly one shoulder for at least 3 months and of a minimum of 3 on a 10 cm visual analogue scale; restriction of active and passive range of motion greater than 30 degrees in two or more planes of movement (external rotation and abduction), a satisfactory x-ray, and adults aged over 18 years of age.
Exclusion criteria
Patients with systemic inflammatory joint disease; radiological evidence of osteoarthritis of the shoulder or fracture; calcification in the region around the shoulder; clinical signs of a complete rotator cuff tear including, notable weakness of arm elevation, a “positive drop sign”, a high riding humeral head on radiological examination or demonstration of complete rotator cuff tear on ultrasound or MRI; allergy to local anaesthetic or iodinated contrast, pregnancy; likely not to comply with follow up or lack of written informed consent.
Outcome results
None listed