Impact of Glenohumeral joint Hydrodilatation on functional recovery in primary versus post breast cancer adhesive capsulitis. A prospective comparative trail.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
Study Overview
Brief Summary
This prospective comparative study evaluates the effectiveness of glenohumeral joint hydrodilatation in adults with adhesive capsulitis by comparing patients with primary idiopathic adhesive capsulitis and those with secondary adhesive capsulitis following breast cancer treatment after failure of conservative management. Adults aged eighteen to sixty five years with significant shoulder pain and restriction of passive range of motion will undergo image guided hydrodilatation followed by a standardized rehabilitation program. Pain relief functional improvement range of motion and quality of life will be assessed at baseline and at one three and six months after intervention. Shoulder Pain and Disability Index will be used as the primary outcome measure while pain intensity quality of life recovery timelines shoulder dyskinesia scar related restriction and rehabilitation adherence will be evaluated as secondary outcomes. The study aims to determine whether post breast cancer adhesive capsulitis shows a different pattern of recovery compared to primary adhesive capsulitis with the expectation that both groups will improve but primary adhesive capsulitis will demonstrate faster and greater functional recovery due to fewer structural and treatment related tissue changes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age between 18 and 65 years.
- •Clinical diagnosis of adhesive capsulitis with Significant restriction in passive ROM of the shoulder joint.
- •Shoulder pain VAS score greater than or equal to 5 that exacerbated by movement.
- •Symptoms persisted for at least three months.
- •Diagnosis of breast cancer and completed definitive treatment.
Exclusion Criteria
- •1.Systemic or structural disorders that could result in limited ROM or pain, such as major trauma, shoulder surgical history, rotator cuff tear, or inflammatory joint disease.
- •2.Male patients and patients with stage IV breast cancer 3.Neurological conditions affecting the upper limb (e.g., stroke, brachial plexopathy, Radiculopathy).
- •4.Radiographically significant pathology in shoulder except mild osteopenia 5.Known allergy to local anaesthetics or steroids.
- •6.Coagulopathy, current anticoagulant therapy, or local skin infection at injection site.
- •Inability to comply with rehabilitation protocol due to physical or cognitive limitation.
- •8.Active breast cancer under current treatment.
- •9.Severe cognitive impairment or psychiatric illness interfering with consent or follow-up
- •Refusal to provide informed consent or non-compliance with follow-up schedule.
Investigators
Safwana Beegum P M
All India Institute of Medical Sciences, Jodhpur