Comparative Efficacy of Radial Shockwave Therapy and Transcutaneous Electrical Nerve Stimulation on Pain and Function in Upper Trapezius Myofascial Pain Syndrome: A Randomized Clinical Trail
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mansi Pokhriyal
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 1.Pain intensity (by Numerical Pain Rating Scale)
Overview
Brief Summary
PURPOSE:
There are many studies available to show the individual efficacy of Radial Shock Wave Therapy and TENS in Upper Trapezius Myofascial Pain Syndrome separately and both are effective. However, to the best of our knowledge, there are few studies available that compare the efficacy of Radial Shock Wave Therapy and TENS in Upper Trapezius Myofascial Pain Syndrome.
So, the purpose of this study is to compare the efficacy of Radial Shock Wave Therapy and TENS on pain and function in Upper Trapezius Myofascial Pain Syndrome. AIM**:**
To compare the efficacy of Radial Shock Wave Therapy and TENS on pain and function in Upper Trapezius Myofascial Pain Syndrome. OBJECTIVES**:**
1. To find out the efficacy of Radial Shock Wave Therapy with standardized exercises on pain and function in Upper Trapezius Myofascial Pain Syndrome.
2. To find out the efficacy of TENS with standardized exercises on pain and function in Upper Trapezius Myofascial Pain Syndrome.
3. To compare the efficacy of Radial Shock Wave Therapy and TENS on pain and function in Upper Trapezius Myofascial Pain Syndrome. HYPOTHESES:
NULL HYPOTHESIS**(H0):**
There is no statistically significant difference between efficacy of Radial Shock Wave Therapy and TENS on pain and function in the Upper Trapezius Myofascial Pain Syndrome.
ALTERNATIVE HYPOTHESIS**(H1):**
There is a statistically significant difference between efficacy of Radial Shock Wave Therapy and TENS on pain and function in Upper Trapezius Myofascial Pain Syndrome. PROCEDURE:
Institutional Ethical Committee (IEC) approval has been taken. All subjects having neck pain or Upper Trapezius Myofascial Pain Syndrome, referred to the Department of Physiotherapy from the Assessment Clinic (ASC) of NILD, will be approached with the proposal of the study. They will be evaluated and screened according to inclusion and exclusion criteria. Subjects meeting the exclusion criteria will not be included. The aim and procedure of the study will be explained in detail to each subject in their most communicable language. Written informed consent will be obtained from the subjects agreeing to participate. The subjects will be randomly divided into two groups by the Block Randomization method.
Subjects in Group A (n=18) will be treated by Radial Shockwave Therapy for 4 sessions (1st, 4th, 7th, and 10th day) along with standardized exercises for exercises for 10 sessions (5 sessions per week for 2 weeks). Subjects in Group B (n=18) will be treated by TENS along with standardized exercises for 10 sessions (5 sessions per week for 2 weeks). Home Exercise Program with Ergonomic care will be explained to all the subjects in both groups.
The demographic data and outcome measures for Pain Intensity by using Numerical Pain Rating Scale [NPRS], Pain Pressure Threshold by Algometer, and Functional status of Neck by using Neck Disability Index [NDI], will be collected from each subject before the intervention and post-intervention on the day after the 10th session.
Rescue medications duly prescribed by the physician will be continued along with the physiotherapeutic approach in both groups in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Both male and female subjects.
- •2.Age between 20-40 years.
- •3.Unilateral side pain.
- •4.Symptoms present for more than 3 months, but no longer than 2 years.
- •6.Simon and Travells essential criteria for Myofascial Pain Syndrome: a-Palpable taught band.
- •b-Exquisite spot tenderness of active MTrPs nodule in a taut band.
- •3-On application of external pressure, pain on tender nodule.
- •4-Painful limit to full stretch ROM.
Exclusion Criteria
- •1.Subjects diagnosed with fibromyalgia, cervical radiculopathy, myelopathy, and acute trauma.
- •2.Musculoskeletal conditions like cervical and upper limb fractures, neck and upper back deformities, etc.
- •3.Subjects who underwent neck or shoulder surgery.
- •4.Rheumatoid Disorders like Rheumatoid arthritis and Ankylosing spondylitis.
- •5.Any vascular symptoms such as basilar insufficiency, thoracic outlet syndrome.
- •6.Diagnosed with neurological conditions like stroke, neuropathy, etc.
- •7.Presence of red flags i.e. infection, malignancy.
- •8.Metal implants in cervical and shoulder region and cardiac pacemaker.
- •9.Any local Skin disorders like eczema in the area of trapezius.
- •10.Steroid injection past 3 months on cervical region and oral steroid medication previous 1 month.
Outcomes
Primary Outcomes
1.Pain intensity (by Numerical Pain Rating Scale)
Time Frame: 2 times-At day 0 and after 2 weeks(10 sessions)
2.Pain Pressure Threshold (by Algometer)
Time Frame: 2 times-At day 0 and after 2 weeks(10 sessions)
3.Function (by Neck Disability Index)
Time Frame: 2 times-At day 0 and after 2 weeks(10 sessions)
Secondary Outcomes
No secondary outcomes reported
Investigators
Mansi Pokhriyal
Affiliated to West Bengal University of Health Sciences