Comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis: A Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Deepak Sharma
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- 1.Pain by Visual Analogue Scale (VAS).
Overview
Brief Summary
PURPOSE OF THE STUDY:
There are various studies available which shows the individual efficacy and few comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy in subjects with Adhesive Capsulitis. However, to the best of our knowledge out of those studies, no study has been conducted to find the comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in Indian population with Adhesive Capsulitis Subjects.
So, the purpose of the study is to find out the comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
AIMS:
To compare the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
OBJECTIVES:
1.To find out the efficacy of Radial Shockwave Therapy with Glenohumeral joint mobilization and supervised exercise on pain, range of motion and function in subjects with Adhesive Capsulitis.
2.To find out the efficacy of Ultrasound Therapy with Glenohumeral joint mobilization and supervised exercise on pain, range of motion and function in subjects with Adhesive Capsulitis.
3.To compare the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
HYPOTHESES
NULL HYPOTHESIS (H0): There is no statistically significant difference between the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
ALTERNATIVE HYPOTHESIS (H1): There is statistically significant difference between the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
PROCEDURE
Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All subjects having shoulder pain or diagnosed with Adhesive Capsulitis by the Assessment clinic of National Institute for Locomotor Disabilities (Divyangjan) and referred to the Department of Physiotherapy will be approached with the proposal of the study. Based on the inclusion and exclusion criteria 34 subjects will be included in the study. Subjects meeting the exclusion criteria will not be included. Those fulfilling the inclusion criteria will be explained about the study in details in their communicable language and written informed consent will be taken. Then, the subjects will be randomly divided into 2 groups by block randomization method by computer generated random blocks.
The demographic data and outcome measures for Pain using VAS, active ROM by Universal half circle goniometer and function by SPADI questionnaire will be collected from each subject pre-intervention and post-intervention after 10th sessions at the end of 2 weeks.
In Group-A subjects will be treated with Radial Shockwave Therapy (RSWT) for 4 sessions [2 sessions per week (on 1st, 4th, 7th and 10th day)]. In Group-B subjects will be treated with Ultrasound Therapy for 10 sessions (5 sessions per week for 2 weeks). Glenohumeral joint mobilization, Supervised Exercise Program (5 sessions per week for 2 weeks) and Home Exercise Program will be given in both the groups.
All the rescue medications, prescribed by the physicians will be continued in both the groups along with Physio-therapeutic approach during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Both male and female subjects.
- •2.Age between 40-60 years.
- •3.Subjects with Adhesive Capsulitis stage II and III.
- •4.VAS score between 3-7.
Exclusion Criteria
- •1.Surgical history of shoulder joint or cervical spine.
- •2.Diagnosed cases of musculoskeletal conditions like Rotator cuff tendinitis or injury, fracture around shoulder, Shoulder impingement syndrome, upper limb deformity etc.
- •3.Diagnosed cases of neurological conditions like Stroke, Parkinson’s disease etc.
- •4.Rheumatological diseases like Rheumatoid Arthritis, Ankylosing Spondylitis.
- •5.Red flag sign like Malignancy, Vascular disorders.
- •6.History of oral steroid in last 1 month and intraarticular corticosteroid injection for Adhesive Capsulitis in last 3 months.
- •7.Implanted Pacemaker.[27] 8.Non-cooperative subjects.
Outcomes
Primary Outcomes
1.Pain by Visual Analogue Scale (VAS).
Time Frame: 2 times - on day 0 and after 2 weeks of interventions
2.Active Abduction, External and Internal rotation ROM by Universal half circle goniometer.
Time Frame: 2 times - on day 0 and after 2 weeks of interventions
3.Function by Shoulder Pain and Disability Index (SPADI)
Time Frame: 2 times - on day 0 and after 2 weeks of interventions
Secondary Outcomes
No secondary outcomes reported
Investigators
Deepak Sharma
National Institute for Locomotor Disabilities (Divyangjan)