| CTRI Number |
CTRI/2025/06/088007 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Dry Needling] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of different types of Needling techniques on muscles near neck in Migraine headache |
|
Scientific Title of Study
|
Comparative effectiveness of Deep, Superficial and Sham Dry Needling on Migraine headache - 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 Priya Sahasrabuddhe PT |
| Designation |
Assistant Professor (Musculoskeletal Physiotherapy) |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Smt Kashibai Navale College of Physiotherapy, near Purnabrahma Hotel, Manaji Nagar, Narhe
Pune
MAHARASHTRA
411041
India |
| Phone |
8888816915 |
| Fax |
|
| Email |
priyasahasrabuddhe.skncopt@sinhgad.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Sahasrabuddhe PT |
| Designation |
Assistant Professor (Musculoskeletal Physiotherapy) |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Smt Kashibai Navale College of Physiotherapy, near Purnabrahma Hotel, Manaji Nagar, Narhe
Pune
MAHARASHTRA
411041
India |
| Phone |
8888816915 |
| Fax |
|
| Email |
priyasahasrabuddhe.skncopt@sinhgad.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Sahasrabuddhe PT |
| Designation |
Assistant Professor (Musculoskeletal Physiotherapy) |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Smt Kashibai Navale College of Physiotherapy, near Purnabrahma Hotel, Manaji Nagar, Narhe
Pune
MAHARASHTRA
411041
India |
| Phone |
8888816915 |
| Fax |
|
| Email |
priyasahasrabuddhe.skncopt@sinhgad.edu |
|
|
Source of Monetary or Material Support
|
| Smt Kashibai Navale General Hospital & College of Physiotherapy,S.No, 49/1, Mumbai Pune Bypass Rd Flyover, Narhe, Pune, Maharashtra 411041. |
|
|
Primary Sponsor
|
| Name |
Dr Priya Sahasrabuddhe PT |
| Address |
S.No. 49/1, Narhe,
Off Mumbai - Pune Bypass,
Pune - 411 041. |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 Priya Sahasrabuddhe PT |
Smt. Kashibai Navale Medical College and General Hospital |
Physiotherapy OPD No 10, Ground Floor, Building No. 13, S.No. 49/1, Off Mumbai - Pune Bypass, Narhe, Pune - 411 041
Pune
MAHARASHTRA |
8888816915
priyasahasrabuddhe.skncopt@sinhgad.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of Smt. Kashibai Navale College of Physiotherapy |
Approved |
| Institutional Ethics Committee, K J Somaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep and Superficial Dry Needling |
Subjects will be divided into 3 groups:
1. Deep Dry Needling + Standard Treatment
2. Superficial Dry Needling + Standard Treatment
3. Sham Dry Needling + Standard Treatment (Comparator/Control group)
Medical treatment of Migraine headache will continue as advised by the Medical Practitioner.
All groups will receive standard treatment for 20 minutes, 3 times a week for 4 weeks
All types of Dry needling techniques will be performed twice a week (approximately 10 min per session) for 4 weeks with minimum 24 hours of gap in between
All groups will receive standard treatment after the dry needling (10 min DN + 20 min Std Treatment)
|
| Comparator Agent |
Sham Dry Needling |
A blunted needle will be poked in the same area without puncturing the skin.
The procedure will be done on the skin over the trigger point.
All groups will receive standard treatment for 20 minutes, 3 times a week for 4 weeks
All types of Dry needling techniques will be performed twice a week (approximately 10 min per session) for 4 weeks with minimum 24 hours of gap in between
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects diagnosed with Episodic Migraine without aura by a Medical Practitioner
2)Subjects of all genders
3)Age between 25-40 years
4)Migraine headache more than 6 months
5)Headache Pain intensity minimum 6 on the Numeric Pain rating Scale (NRS) on average.
5)Minimum 1 episode of migraine headache in previous week.
6)At least one active TrP in minimum 2 of the following muscle – Suboccipetal, Upper Trapezius, Sternocleidomastoid ipsi-laterally over the symptomatic side reproducing their headache symptoms.
|
|
| ExclusionCriteria |
| Details |
1) History of head or neck trauma or surgery
2) Cervical radiculopathy
3) Physiotherapy in the cervical area during the previous 3 months
4) Pregnancy
5) Contraindication to DN
6) Any local or systemic infections
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Headache frequency will be recorded as the number of headache days in the past week.
2. A Numerical pain rating scale will be used to assess average headache intensity in past week.
3. Health-related quality of life will be measured using Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ)
4. Pressure-pain threshold will be measured using a manual Mechanical Algometer over Upper Trapezius and Suboccipital muscle.
|
1. Baseline
2. Post Intervention (4 weeks)
3. After 3 months
4. After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• A Numerical pain rating scale will be used to assess average headache intensity in past week.
• Health-related quality of life will be measured using Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ)
• Pressure-pain threshold will be measured using a manual Mechanical Algometer over Upper Trapezius & Suboccipital muscle.
|
Assessment of outcome measures will be at baseline, post intervention 4 weeks, 3months after 6 months from beginning of treatment. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
24/06/2025 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Migraine is associated with a wide range of comorbidities, which range
from stress and sleep disturbances to suicide. Migraine Headache prevalence is
found to be on the rise due increase in screen time, stress and busy
lifestyle.
Aim of this study is to
assess the short-term and long-term effectiveness of Deep, Superficial and Sham
Dry Needling on headache frequency, intensity, health-related quality of life
and pressure-pain threshold in migraine patients.
Objective is to assess the short-term and long-term effectiveness
of Deep Dry Needling on headache
frequency, intensity, health-related quality of life and pressure-pain
threshold in migraine patients.
Procedure: Baseline assessment will be
done. Subjects will be divided into
3 groups:
- Deep Dry Needling + Standard Treatment
- Superficial Dry Needling + Standard Treatment
- Sham Dry Needling + Standard
Treatment
All types of Dry
needling techniques will be performed twice a week (approximately 10 min per
session) for 4 weeks with minimum 24 hours of gap in between.
A follow up assessment
will be after 4 weeks, and 3 months and 6 months from the start of treatment. |