| CTRI Number |
CTRI/2024/07/071396 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Radial Shockwave and Transcutaneous Electrical Nerve Stimulation on myofascial pain syndrome subjects. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Pokhriyal |
| Designation |
Post Graduate Student |
| Affiliation |
Affiliated to West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata, North Twentyfour Parganas, West Bengal, 700090, India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9315059321 |
| Fax |
|
| Email |
mansipokhriyal37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sourov Saha |
| Designation |
Senior Physiotherapist cum Junior Lecturer |
| Affiliation |
Affiliated to West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata, North Twentyfour Parganas, West Bengal, 700090, India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9433845886 |
| Fax |
|
| Email |
sourov.saha.pht@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Pokhriyal |
| Designation |
Post Graduate Student |
| Affiliation |
Affiliated to West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata, North Twentyfour Parganas, West Bengal, 700090, India
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9315059321 |
| Fax |
|
| Email |
mansipokhriyal37@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Locomotor Disabilities (Divyangjan),BT Road, Bonhooghly, Kolkata, West Bengal, Pin Code-700090 |
|
|
Primary Sponsor
|
| Name |
Mansi Pokhriyal |
| Address |
Room Number 117, Department of Physiotherapy, BT Road, Bonhooghly, Kolkata, West Bengal, Pin Code-700090, North Twentyfour Parganas WEST BENGAL |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansi Pokhriyal |
National Institute for Locomotor and Disabilities (Divyangjan) |
Room Number 117, Department of Physiotherapy, BT Road, Bonhooghly, Kolkata, Pin Code-700090
North Twentyfour Parganas
West Bengal
North Twentyfour Parganas
WEST BENGAL |
9315059321
mansipokhriyal37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute for Locomotor Disabilities (Divyangjan) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radial Shockwave Therapy |
All the subject in this group will be treated by Radial Shockwave Therapy, standardized exercises and HEP. Treatment will be given with dose of 1.2 bar, 5 Hz frequency, and 1000 shocks in Upper Trapezius for 4 sessions (1st, 4th, 7th, and 10th day) and standardized exercises for 10 sessions |
| Comparator Agent |
TENS |
All the subject in this group will be treated by TENS Therapy, standardized exercises and HEP. Treatment will be given for 10 minutes with Burst mode, Frequency: 100 Hz, Pulse Width: 250 msec for 10 sessions |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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.
5.Pain score of 4-8 according to the Numerical Pain Rating Scale (NPRS).
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.
|
|
| ExclusionCriteria |
| Details |
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.
11.Non-cooperative patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain intensity (by Numerical Pain Rating Scale)
2.Pain Pressure Threshold (by Algometer)
3.Function (by Neck Disability Index)
|
2 times-At day 0 and after 2 weeks(10 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|