| CTRI Number |
CTRI/2025/07/090219 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Dry Needling and Ultrasound Therapy for Shoulder and Neck Muscle Pain: A Clinical Trial |
|
Scientific Title of Study
|
Dry needling versus ultrasound therapy in upper trapezius muscle: 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 Devanshi Gupta |
| Designation |
Masters of dental surgeon mds oral medicine and radiology |
| Affiliation |
I.T.S Dental college , ghaziabad , muradnagar |
| Address |
Room no. 1, Department of oral medicine and radiology, I.T.S Dental college, ghaziabad, muradnagar, Aslat nagar 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
07078747200 |
| Fax |
|
| Email |
gupta.devanshi4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Rathore |
| Designation |
HOD and professor |
| Affiliation |
I.T.S Dental college , ghaziabad , muradnagar |
| Address |
Room no. 1, Department of Oral Medicine and Radiology, I.T.S Dental College, Ghaziabad, Muradnagar, Aslat Nagar 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9999674543 |
| Fax |
|
| Email |
dr.akshayrathore@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Yadav |
| Designation |
Associate Professor |
| Affiliation |
I.T.S Dental college , ghaziabad , muradnagar |
| Address |
Room no. 1, Department of oral medicine and radiology, I.T.S Dental college, ghaziabad, muradnagar, Aslat nagar 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
09717789413 |
| Fax |
|
| Email |
annuudentalcare011@gmail.com |
|
|
Source of Monetary or Material Support
|
| I.T.S Dental college,Muradnagar Ghaziabad,
Aslat nagar 201206 |
|
|
Primary Sponsor
|
| Name |
Dr Devanshi Gupta |
| Address |
I.T.S Dental college,Muradnagar Ghaziabad, Aslat nagar 201206 |
| 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 Devanshi Gupta |
I.T.S Dental college |
Room no. 1, Department of oral medicine and radiology, I.T.S Dental college, ghaziabad, muradnagar, Aslat nagar 201206
Ghaziabad
UTTAR PRADESH |
07078747200
gupta.devanshi4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S INSTUTIONAL ETHICS COMMITTEE (IIEC) |
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 |
dry needling |
dry needling therapy, where a sterile, filiform needle measuring 23 mm in length and 0.30mm in diameter was inserted into the active myofascial trigger points of the upper trapezius muscle using the Hong’s technique |
| Comparator Agent |
ultasound theraphy |
therapeutic ultrasound therapy, delivered using a continuous mode at 1 MHz frequency and 1 W/cm² intensity, with each trigger point treated for 10 minutes per session for continuous 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study of age 18 to 35 years, who experienced pain in the neck/shoulder girdle region and one or more palpable myofascial trigger points (MTrP) in the upper trapezius.
|
|
| ExclusionCriteria |
| Details |
• Fibromyalgia,
• Chronic Lyme disease,
• Cervical radiculopathy,
• Head/neck/shoulder girdle surgeries,
• New medication or change within 6 weeks
• Current use of acupuncture
• Spinal pathology is eliminated
• Previous cervical fracture
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score, Pressure Pain Threshold, and Range of motion |
1st week, 2nd week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized clinical trial evaluated the efficacy of dry needling versus ultrasound therapy in treating myofascial pain in the upper trapezius muscle. A total of 34 patients were allocated into two equal groups (n = 17 each). Pain and function were measured using three outcome measures: Pressure Pain Threshold (PPT), Tape Measurement for range of motion, and Visual Analog Scale (VAS) for pain, at baseline, 1st week, 2nd week, and 4th week. Both groups exhibited substantial improvements over time; however, the dry needling group showed greater reductions in pain intensity and better enhancements in cervical range of motion by the 4th week. Intergroup analysis indicated statistically significant differences favoring the dry needling group, particularly for VAS and tape measurement outcomes |