| CTRI Number |
CTRI/2026/03/105527 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Shockwave Therapy vs Handheld Vibration in Treating Upper Trapezius Trigger Points |
|
Scientific Title of Study
|
comparison of the efficacy of extracorporeal shockwave therapy and handheld vibrator on trigger point of upper trapezius in myofascial pain syndrome: a randomized clinical trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bobby Kumari PT |
| Designation |
Student(pursuing MPT Musculoskeletal Physiotherapy) |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute For Persons with Physical Disabilities |
| Address |
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan) physiotherapy department room no 21
4 Vishnu Digambar Marg New
Delhi
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan) physiotherapy department room no 21
4 Vishnu Digambar Marg New
Delhi 110002 Central DELHI
Central
DELHI
110002
India |
| Phone |
9693725864 |
| Fax |
|
| Email |
bobbykumari463@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mr K Ramprabhu PT |
| Designation |
Assistant Professor (MPT Orthopaedics) |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan) physiotherapy department room no 21
4 Vishnu Digambar Marg New
Delhi 110002
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan) physiotherapy department room no 21
4 Vishnu Digambar Marg New
Delhi 110002
Central
DELHI
110002
India |
| Phone |
919818885324 |
| Fax |
|
| Email |
ramp76@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mr K Ramprabhu PT |
| Designation |
Assistant Professor (MPT Orthopaedics) |
| Affiliation |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan)
4 Vishnu Digambar Marg New
Delhi 110002 Central DELHI
Pt. Deendayal Upadhyaya National Institute For Persons
with Physical Disabilities(Divyangjan)
4 Vishnu Digambar Marg New
Delhi 110002 Central DELHI
Central
DELHI
110002
India |
| Phone |
919818885324 |
| Fax |
|
| Email |
ramp76@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) 4-Vishnu Digamber Marg New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Rehabilitation institute] |
|
|
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 Bobby KumariPT |
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
Department of Physiotherapy Room no.21
4-Vishnu Digamber Marg New Delhi-110002
Central
DELHI |
09693725864
bobbykumari463@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extracorporeal Shockwave Therapy |
Participants will receive extracorporeal shockwave therapy applied to the upper-trapezius trigger point using an electro-pneumatic device (3000 pulses/session; 1.3–1.5 bar; 6–10 Hz). Treatment will be given 2 sessions/week for 3 weeks (6 sessions). All participants will also follow a standardized clinic exercise and home exercise program with ergonomic advice. |
| Comparator Agent |
Vibration Therapy |
Participants will receive localized handheld vibration therapy over the upper-trapezius trigger point at 35–50 Hz for 5 minutes per session. Treatment will be given 3 sessions/week for 3 weeks (9 sessions). The same standardized clinic exercise and home exercise program with ergonomic advice will be provided. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants with a trigger point in the upper trapezius muscle in MPS (diagnosis based on criteria made by 2 physiatrists Travell and Simons. that is a well-defined tender hypersensitive palpable nodule located within a taut band of the upper trapezius muscle typically referred to as pain patterns and LTR(Local Twitch Response ) elicited by snapping palpation of the TrP)
Onset of pain within 3 months
A more painful side will be included in the study (either left or right)
Mild to moderate pain intensity at baseline (VAS pain between 3 and 6)
Subjects who have not received any treatment for their symptoms in the last 1 month
|
|
| ExclusionCriteria |
| Details |
Neurological conditions such as cervical disc disorder (radiculopathy herniation myelopathy) or stroke and Parkinsons disease
Diagnosed cases of musculoskeletal conditions like rotator cuff tendinitis neck and upper back fracture shoulder impingement syndrome and upper limb deformity (fixed contracture or deformities of the shoulder and neck)
Rheumatological diseases like rheumatoid arthritis and ankylosing spondylitis
Heart diseases
Patient with a pacemaker
Pregnant women or breastfeeding women
Any drug therapy or anticoagulant therapy
Presence of skin infection
Has the participant received any local anesthesia
Severe psychiatric problem
Participants with a bleeding tendency
Red flag signs like malignancy and vascular disease
Surgical history of cervical and shoulder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Pressure Threshold Algometer |
Baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogous Scale
Universal Goniometer
Neck Disability Index |
2 Points(baseline and 3 weeks) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
19/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to compare the effectiveness of Extracorporeal Shockwave Therapy (ESWT) and Handheld Vibration Therapy in treating upper trapezius trigger points in individuals with Myofascial Pain Syndrome. Participants will be randomly assigned to either an ESWT group or a vibration therapy group. In ESWT groups will receive treatment two times per week for three weeks and in vibration therapy group will receive treatment three times per week for three weeks along with a common standard exercises home exercise program and ergonomic care.
Pain intensity, pressure pain threshold, cervical range of motion and neck disability index to asses how pain impact on daily activities and overall functional disability will be measured before and after the intervention period. The study seeks to determine which modality is more effective in reducing pain and improving function. Findings from this study may help guide evidence-based, non-invasive physiotherapy management of upper trapezius myofascial pain |