None listed
Conditions
Brief summary
Adhesive capsulitis, otherwise known as periarthritis shoulder or frozen shoulder, causes pain and stiffness of the glenohumeral joint. It affects 2-5% of the population and 20% of diabetics and often takes months or years to resolve, thus adding a significant burden to New Zealand’s health system. Level one evidence points to corticosteroid injections (CSI) as being effective if given early. However, they are short-acting and can cause many adverse effects, particularly hyperglycaemia to those with diabetes, but also infection, facial flushing, avascular necrosis, tendon rupture, chondronecrosis, fat atrophy and skin depigmentation. The use of platelet-rich plasma (PRP) for FS has been studied in four recent randomised controlled trials (RCTs) all demonstrating equal or superior efficacy compared to other nonoperative treatment modalities, including corticosteroid injection, and with less adverse events. However, there is a need for further high-quality evidence as these studies have small sample sizes and various methodological weaknesses including patient selection criteria, blinding technique, lack of ultrasound guidance for the injection and short follow up. The aim of this study is to compare the treatment of frozen shoulder using platelet rich plasma injection (PRPI) and corticosteroid injection (CSI). We hypothesise that PRPI is as effective as CSI in treating and thus may provide a lower risk alternative treatment of this condition.
Interventions
Intra-articular platelet-rich plasma injection
6mL of PRP (centrifuged at 580 g, 2000 RPM for 8 minutes) combined with 0.25mL calcium chloride for platelet activation.
Administered once, except in the case of ongoing pain (>50% baseline pain at 6 weeks) when repeat injection may be offerred up to 12 weeks later. In case of ongoing pain beyond the repeat injection, participants will be offered blinded crossover treatment at 6 months.
Sponsors
Dr Matthew Brick
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients aged 18 years or over living in Auckland region • Specialist-confirmed diagnosis of adhesive capsulitis • Shoulder pain and restricted range of motion in shoulder • Symptoms between 1-12 months • Shoulder radiograph and ultrasound scan. Radiology will document capsular thickness, bursal thickness, prevalence of co-existing calcific tendonitis, rotator cuff tendinopathy/minor tear or joint effusion. These findings are not exclusion criteria.
Exclusion criteria
• Serious orthopaedic or medical co-morbidity including osteoarthritis, fracture, dislocation, massive rotator cuff tear, infection, malignancy, haematological disorder, chronic regional pain syndrome of the shoulder, crystal arthropathy of shoulder confirmed on previous aspirate, previous shoulder injection within 3 months • Participants need to avoid steroids and non-steroidal anti-inflammatories (NSAID) in the week prior and week after their injection. This will be screened for during the consent process and immediately before the procedure. Patients using these medications will be deferred to a later procedure day when they haven’t used them for over one week prior.
Outcome results
None listed