None listed
Conditions
Brief summary
Background Frozen shoulder is a common problem, affecting up to 5% of the population, leaving long-term disability and hence impairing the quality of life of patients. It still remains to be an ill defined term. There have been various methods for the management of ‘frozen shoulders’ namely: analgesia; hydrodilatation;corticosteroid injections; manipulation; and arthroscopic release of contractures. There have been increasing and equivocal evidence with regards to the efficacy of hydrodilatation for the management of adhesive capsulitis. The effects of hydrodilatation have been shown to improve pain and range of movement from the effects of capsular distension in some prospective studies. Previous trials have shown negative results which may have been undermined from an inadequate designed trial or technique. Aims and hypothesis To investigate the clinical significance of the effect of hydrodilatation. This raises our clinical research question as to whether hydrodilatation with corticosteroid injection is the superior form of treatment. Whether the outcome shows superiority of the treatment or not, this would have an impact on the way clinicians manage their patients with frozen shoulders. Above all, the emphasis is on the outcome for patients. Healthcare policies may alter based on the findings. Method Patients will be randomly allocated into two groups. These two groups are patients receiving corticosteroid and local anaesthetic with and without hydrodilatation. Allocation concealment will be ensured. Patients referred to Monash Medical Centre, Clayton rheumatology outpatients department with suspected ‘frozen shoulder’ will be screened. Written and verbal informed consent will be obtained.Inclusion criteria: limitation of shoulder motion with pain at rest or on movement, duration of symptoms over 3 months. Exclusion criteria: Osteoarthritis, systemic inflammatory disorder, previous surgery within 6 months, pregnant, rotator cuff disease, referred pain from spine. Contraindications to the procedure: mental illness, age<18yo. Technique The patient lies down and the overlying skin of the affected shoulder is sterilised The hydrodilatation technique involves the insertion of a needle from the front by a radiologist into the shoulder joint guided by a small infusion of contrast material confirmed on plain Xray. The injection for hydrodilatation,containing normal saline, will continue to be injected until distension is achieved. Post treatment patients will receive a daily self-assisted exercise programme. This will be a double blinded randomization study where patients are not aware of what treatments they are receiving and clinicians evaluating patients at weeks 4,8 and 12 will not know which two groups of patients are being treated.
Interventions
Corticosteroid and local anaesthetic combination injection with and without hydrodilatation. The injection will contain 2mL of 2% lignocaine and 1mL of bethamethasone. The procedure is performed initially by having the patient lie in the supine position. The overlying skin of the affected shoulder is cleaned with anti-septic solution. Sterile gloves are used. The hydrodilatation technique would involve the insertion of a 22G needle of variant length(dependent on patient size) from an anteri
Corticosteroid and local anaesthetic combination injection with and without hydrodilatation. The injection will contain 2mL of 2% lignocaine and 1mL of bethamethasone. The procedure is performed initially by having the patient lie in the supine position. The overlying skin of the affected shoulder is cleaned with anti-septic solution. Sterile gloves are used. The hydrodilatation technique would involve the insertion of a 22G needle of variant length(dependent on patient size) from an anterior approach into the glenohumeral joint guided by a small infusion of radio-opaque contrast material. A 22G smaller needle is used in order to prevent leakage of contrast which may obscure the visualisation of radio opaque material within capsule. The position is then confirmed on imaging intensifier. Normal saline will continue to be injected until arthrographic distension or capsular rupture is achieved with a volume of at least 30mL(used by previous studies). The treatment is only administered once in a brief session of approximately 5 minutes and patients followed up at weeks 4,8 and 12 post-treatment. It is proven that physiotherapy following hydrodilatation is not shown to be beneficial in terms of pain, function and quality of life. We have therefore provided patients with a daily self-assisted exercise programme that many clinicians instruct the patients to follow in order to maintain range of movement post-treatment. This mainly involves passive range of movement exercises such as passive external rotation and pendular exercises for the upper limbs.
Sponsors
Dr.Kishen Narayanasamy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
patients with adhesive capsulitis with a -generalised limitation of glenohumeral motion with pain at rest or on movement in 2 or more planes and with a limited range of movement of less than 30 degrees. -duration of symptoms greater than 3 months
Exclusion criteria
Osteoarthritis, systemic inflammatory disorder – rheumatoid arthritis, previous surgery within 6 months, pregnant, rotator cuff disease, referred pain from cervical spine, contraindications to the procedure: warfarin, contrast allergy, trauma within the last six months of presentation, mental illness, fibromyalgia
Outcome results
None listed