COMPARISON OF ULTRASOUND GUIDED PULSED RADIOFREQUENCY ABLATION AND BUPIVACAINE BLOCK OF SUPRASCAPULAR NERVE IN REDUCTION OF PAIN AND DISABILITY IN HEMIPLEGIC SHOULDER PAIN: A RANDOMIZED CONTROLLED STUDY
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Regional Institute of Medical Sciences Imphal
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- 2. Shoulder Range Of Motion (ROM)
Overview
Brief Summary
The occurrence of shoulder pain after stroke is quite common in hemiplegia. Shoulder pain can negatively affect rehabilitation outcomes. It may not only interfere with shoulder function, but also interfere with balance, walking, transfers and performance of self-care activities. Many treatment options are available depending on cause of HSP like analgesics, anticonvulsants like (gabapentin or carbamazepine), oral corticosteroids, steroid injection (intra-articular or subacromial or biceps tendon sheath ), stellate ganglion block, manipulation, non-pharmacological modalities like positioning of affected limb, passive range of motion exercises, sling when upright, transcutaneous nerve stimulation, ultrasound, functional electric stimulation.
Pulsed radiofrequency ablation of suprascapular nerve and suprascapular nerve block both have been proved to produce good results in primary care as suprascapular nerve supplies 70 percent sensory supply of the shoulder joint, but there is no comparative study between ultrasound guided radiofrequency ablation of suprascapular nerve and suprascapular nerve block available in literature at present. Therefore a randomized controlled study will be done in the Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences; Imphal to compare the effectiveness between ultrasound guided radiofrequency ablation of suprascapular nerve and suprascapular nerve block in reduction of pain and functional disability in HSP. The outcome variables will be measured before starting intervention (baseline) and at 1, 4, 12 and 24 weeks post-intervention follow up. Data will be analyzed by using SPSS Version 21. To represent descriptive statistics, mean and standard deviation will be used, for analytical statistics independent t test will be used and p-value < 0.05 will be taken as significant.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed as acute stroke within the previous 12 months with hemiplegic shoulder pain.
- •Pain severity with minimum score of 5 based on 10 scale VAS.
- •Willingness to comply with treatment and follow-up assessments.
Exclusion Criteria
- •1.Cognitive deficit that precluded patients from reliably using subjective outcome measures scales [Mini Mental State Examination] 2.Allergy to proposed injection agents (lidocaine and Bupivacaine) 3.Degenerative changes at the glenohumeral joint as shown by a standard anteroposterior radiograph 4.Any recent febrile or infectious disease (systemic & local) 5.History of any malignancy (including hematologic and non-hematologic malignancies) 6.Previous history of systemic inflammatory joint disease like rheumatoid arthritis, gout, etc 7.Metabolic or systemic disease like ischemic heart disease, hepatitis, uncontrolled diabetes mellitus 8.Any trauma, fracture, bony malformation or dislocation of shoulder 9.History of autoimmune and hematological disorders 10.Intra or periarticular steroid injection to shoulder in previous 2 months 11.Platelet counts of less than 150,000 per micro liter 12.Cardiac arrhythmia or a pacemaker 13.Hemorrhagic stroke.
Outcomes
Primary Outcomes
2. Shoulder Range Of Motion (ROM)
Time Frame: At 1st, 4th, 12th and 24th week
1. Visual Analog Scale (VAS)
Time Frame: At 1st, 4th, 12th and 24th week
Secondary Outcomes
- Shoulder Pain And Disability Index (SPADI)(1, 4, 12 and 24 weeks)