| CTRI Number |
CTRI/2026/02/103538 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| 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
|
A Study on the Benefit of Muscle Relaxation Therapy and Ultrasound Treatment for Neck-Related Headaches |
|
Scientific Title of Study
|
Effect of Myofascial Release and Phonophoresis on Cervicogenic Headache |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Head of Department and Assistant Professor |
| Affiliation |
Physiotherapy Department Punjabi University Patiala |
| Address |
Physiotherapy Department
Punjabi University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
09417802490 |
| Fax |
|
| Email |
Sandeep.physiotherapy@pup.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Head of Department and Assistant Professor |
| Affiliation |
Physiotherapy Department Punjabi University Patiala |
| Address |
Physiotherapy Department
Punjabi University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
09417802490 |
| Fax |
|
| Email |
Sandeep.physiotherapy@pup.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Harjinder Singh |
| Designation |
Postgraduate Student |
| Affiliation |
Physiotherapy Department Punjabi University Patiala |
| Address |
Physiotherapy Department
Punjabi University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
9082200031 |
| Fax |
|
| Email |
nimratjattana1234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Harjinder Singh |
| Address |
Physiotherapy Department Punjabi University Patiala |
| 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 Sandeep Singh |
Bhai Ghaniya health centre |
Orthopaedic OPD-I Physiotherapy Unit Punjabi University Patiala
PUNJAB
Patiala
PUNJAB |
09417802490
Sandeep.physiotherapy@pup.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial release
Phonophoresis |
Myofascial release for 10 minutes thrice a week for 4 weeks
Phonophoresis for 5 minutes thrice a week for 4 weeks |
| Comparator Agent |
Myofascial release |
Myofascial release for 10 minutes thrice a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with cervicogenic headache as per ICHD criteria as follows
1 The headache started around the same time as onset of cervical disorder (neck pain)
2 Headache has significantly improved or resolved in parallel with improvement of the cervical disorder or lesion.
3 Cervical range of motion is reduced along with headache and headache is made significantly worse by provocative manoeuvres of cervical region.
4 The headache is relieved by relief of pain arising from structures of neck or their nerve supply.
5 Presence of myofascial trigger points on upper neck musculature |
|
| ExclusionCriteria |
| Details |
1 Pregnancy
2 Having history of other types of headaches like tension type headaches or migraine
3 Having history of other musculoskeletal conditions like Ankylosing Spondylitis, Rheumatoid Arthritis, fractures or tumors
4 Individuals who have undergone brain or spinal surgeries
5 Individuals with psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Headache Disability Index
|
At baseline and end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
At baseline and end of 4th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/03/2026 |
| 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
|
Effect of Myofascial Release and Phonophoresis on Cervicogenic Headache
Headache is defined as pain in any area of the head. Headache disorder are among the most
prevalent and disabling condition worldwide and ranked 6th among the leading causes of years
lived with disability(YLDs). Cervicogenic headache (CGH), a secondary headache often linked
to neck musculoskeletal issues and myofascial trigger points, significantly impacts daily
functioning and productivity.
Background
CGH affects around 4.1% of the population, more common in women, and is characterized by
unilateral head pain aggravated by neck movement, with possible symptoms like nausea,
dizziness, and visual disturbances. Trigger points in neck muscles such as the trapezius and
sternocleidomastoid, along with fascial tightness, contribute to CGH. Non-pharmacological
approaches like physiotherapy are preferred due to side effects of long-term drug use.
Interventions
Myofascial Release (MFR): Manual technique applying sustained pressure to relieve muscle
tightness, reduce pain, and improve flexibility.
Phonophoresis: Use of therapeutic ultrasound to enhance topical drug absorption (e.g.,
diclofenac), reducing inflammation and pain at trigger points.
Aim –
To determine the combined effect of MFR and phonophoresis on CGH symptoms and
quality of life.
Objectives
1. Assess effectiveness of MFR alone.
2. Assess effectiveness of MFR with phonophoresis.
3. Compare both interventions in terms of pain relief, disability reduction, and quality of life improvement.Methodology
Design: Experimental study.
Sample:30 participants (24–44 years), diagnosed with CGH, randomized into two groups (n=15 each).
Group A: MFR + phonophoresis, 3 times/week for 4 weeks.
Group B: MFR only, same frequency and duration.
Outcome Measures: Numeric Pain Rating Scale (NPRS), Headache Disability Index (HDI), and SF-36
Quality of Life Survey.
Analysis: Pre- and post-intervention comparisons using statistical methods.
Significance – This research could provide empirical evidence for a combined physiotherapy approach,
potentially enhancing CGH management strategies and expanding non-pharmacological
treatment options in physiotherapy practice.
|