| CTRI Number |
CTRI/2025/02/081009 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| 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
|
Effects of different type of physiotherapy for pain, range of motion and disability in people with headache referred to neck |
|
Scientific Title of Study
|
Efficacy of multimodal physiotherapy on pain, range of motion and functional disability in subjects with cervicogenic headache: A Randomized Controlled 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 |
Jiya Kharbe |
| Designation |
post graduate student |
| Affiliation |
NITTE Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575 018
India |
| Phone |
7020774580 |
| Fax |
|
| Email |
jiya.kharbe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
NITTE Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575 018
India |
| Phone |
917760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
NITTE Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
917760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India
Dakshina Kannada
KARNATAKA
575018 |
|
|
Primary Sponsor
|
| Name |
Jiya Kharbe |
| Address |
NITTE INSTITUE OF PHYSIOTHERAPY, DERALAKATTE, MANGALURU KARNATAKA 575018 |
| 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 Nityal Kumar |
NITTE DEEMED TO BE UNIVERSITY |
A Constituent unit of Nitte (Deemed to be University)
Medical Science Complex, Post Nithyananda Nagar, Deralakatte, Mangaluru - 575 018, Karnataka India
Dakshina Kannada
KARNATAKA |
7760547669
nityalkumar2020@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Nitte institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional therapy |
Participants will receive treatment three times per week for total 4 weeks with session lasting 30 minutes for intervention group.
In this intervention group, patient will receive TENS for 15 minutes with frequency of 100Hz.
.Strengthening exercise for weak muscles like cervical flexors muscle, rhomboid muscle and lower trapezius muscles for 3 sets of 10-15 repetition for each side, and there will be increased in the number of repetition or load progression according to individual tolerance. Exercises: I. Isometric neck flexion (5-7 sec hold/ 10 repetition) II. Chin tucks (10-15 sec hold/ 2 sets) III. Upper trapezius stretching and strengthening (20-30 sec hold/ 3 repetition) IV. Scapular squeeze (10 repetition/ 2 sets) V. Prone Y raise (10 repetition/ 2 sets) VI. Modified side lying external rotation (10 repetition/ 2 sets) |
| Intervention |
multimodal therapy and conventional therapy |
Participants will receive treatment three times per week for total 4 weeks with session lasting 45 minutes for intervention group.
In this intervention group, patient will receive TENS for 15 minutes with frequency of 100Hz.
Cervical SNAG mobilization posterior anterior glide on facet joint of C2 with 10 second hold with 10 repetition followed by 30 second rest period, include 2 sessions per week.
patient education on cervicogenic headache on dos and donts through pamphlet.
4.Strengthening exercise for weak muscles like cervical flexors muscle, rhomboid muscle and lower trapezius muscles for 3 sets of 10-15 repetition for each side, and there will be increased in the number of repetition or load progression according to individual tolerance.
Exercises:
I. Isometric neck flexion (5-7 sec hold/ 10 repetition)
II. Chin tucks (10-15 sec hold/ 2 sets)
III. Upper trapezius stretching and strengthening (20-30 sec hold/ 3 repetition)
IV. Scapular squeeze (10 repetition/ 2 sets)
V. Prone Y raise (10 repetition/ 2 sets)
VI. Modified side lying external rotation (10 repetition/ 2 sets)
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. University students of various institution under Nitte Deemed to be University
2. Age 19-25 years old
3. Pain intensity on NPRS with a score between 3 to 8
4. One episode of pain in last 3 months
5. Flexion rotation test positive if restrictions more than 32 to 33 degrees
6. Headache impact test positive with score of 50 and above
7. Neck disability index with minimum or more than 20 %
8. Who are willing to participate in the given study |
|
| ExclusionCriteria |
| Details |
neuralgia)
2) Vertebrobasilar insufficiency
3) Trauma to neck in past 2 years
4) Surgery in past 2 years
5) History of neurological, cardiovascular and cerebral palsy
6) Long term corticosteroids
7) Severe operation around neck region
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. flexion rotation test
2. numerical pain rating scale |
at baseline, 2nd week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
headache impact test-6
neck disability index |
at baseline, 2nd week & 4th week |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to assess the effectiveness of multimodal physiotherapy in reducing pain, improving cervical range of motion, and decreasing functional disability in individuals with cervicogenic headache through a randomized controlled trial (RCT). Conducted at NITTE Deemed to be University, Mangaluru, the study includes 32 participants, randomized into two groups: the experimental group (receiving multimodal therapy plus conventional therapy) and the control group (receiving only conventional therapy). The intervention spans four weeks with two sessions per week, and assessments are conducted at baseline, week two, and week four by a blinded assessor. The control group undergoes TENS (10 minutes) and strengthening exercises, while the experimental group receives TENS (15 minutes, 100Hz frequency) with electrodes on C4 and C7 spinous processes, cervical SNAG mobilization on C2 facet joint, patient education, and strengthening exercises targeting cervical and scapular muscles. Data will be analyzed statistically to determine whether multimodal therapy provides superior benefits over conventional therapy alone in managing cervicogenic headache. |