| CTRI Number |
CTRI/2025/09/094046 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| 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
|
Can Nerve Stretching Help Reduce Pain and Difficulty in Daily Life for Young People with Tension Type Headache? |
|
Scientific Title of Study
|
Effect of neural mobilization technique on pain and headache related disability among young
adults with tension-type headache: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Huzaifa Yaman Arihole |
| Designation |
Post Graduation Student |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
University Road Deralakatte Mangaluru 575018 Karnataka India Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
08105646132 |
| Fax |
|
| Email |
huzaifayaman000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
University Road Deralakatte Mangaluru 575018 Karnataka India Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Huzaifa Yaman Arihole |
| Designation |
Post Graduation Student |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
University Road Deralakatte Mangaluru 575018 Karnataka India Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
08105646132 |
| Fax |
|
| Email |
huzaifayaman000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical COllege Hospital Deralakatte Mangalore |
| Yenepoya Physiotherapy College Mangalore |
|
|
Primary Sponsor
|
| Name |
Huzaifa Yaman Arihole |
| Address |
University Road Deralakatte Mangaluru 575018 Karnataka India Tel: 0824-2206000 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Lourdhuraj I |
University Road Deralakatte Mangaluru 575018 Karnataka Phone 9940529169 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Huzaifa Yaman Arihole |
Yenepoya Medical College Hospital Mangalore |
7th floor Out-Patient Department of Physiotherapy and Occupational Therapy Yenepoya Medical College Hospital Deralakatte Mangalore
Dakshina Kannada
KARNATAKA |
08105646132
huzaifayaman000@gmail.com |
| Huzaifa Yaman Arihole |
Yenepoya Physiotherapy College |
6th floor Pharmacy Building Yenepoya Physiotherapy College Naringana Mangalore
Dakshina Kannada
KARNATAKA |
08105646132
huzaifayaman000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neural Mobilization Technique (NMT) [15 Min]
• Cranio-cervical flexion mobilization. (5 mins)
• Lateral cervical sliding (5 mins)
• Opening the mouth in cranio-cervical flexion (5 mins)
Relaxation self-massage (5 mins)
|
NMT in accordance with the established protocol, which will be provided twice a week for the first two weeks followed by once in a week for 3rd and 4th week.
Procedure:
Five minutes for each mobilization, the protocol would last fifteen minutes. The following order of techniques will be used:
• Cranio-cervical flexion mobilization: Anterior rotation of the head, will be made to stimulate the meninges. The patient will be then requested to lower and retract their shoulders while gradually extending both elbows to produce mechanical stress in the neurological system.
• Lateral cervical sliding: Elveys method involves sliding the patients cervical region laterally in order to activate the brachial plexus. Shoulder mobility will be permitted for participants. Participants will be instructed to gradually extend their elbows, then supinate their forearms and dorsally bend their fingers and carpal bones in order to increase mechanical stress.
• Opening the mouth in cranio-cervical flexion: Patients will be asked to gradually extend their elbows, followed by forearm supination and dorsal flexion of the carpal and fingers in order to increase mechanical stress. We will passively hold the cranio-cervical flexion with one hand while opening the mouth with the other hand. This will increase deformation of the trigeminal nerve, primarily the mandibular branch.
This will be then followed by Self relaxation massage for 5 minutes making it a 20 minutes intervention session.
|
| Comparator Agent |
Self Relaxation Massage (20 Mins)
1. Self Neck Massage (5 Mins)
2. Self Parieto-Occipital region Massage (5 mins)
3. Self Temporal region Massage (5 Mins)
4. Self Frontal Massage (5 Mins)
|
The SRM will be self-administered by participants, with guidance given by interventionist. It will consist of gentle, superficial pressing actions focused specifically on the tight of tender regions around the head, performed primarily using the fingers for 20 mins.42
The SRM will occur twice a week for first two weeks, followed by once in a week for next two weeks. The interventionist will teach the technique at the first meeting focusing five minutes each for neck, occipital, parietal and frontal and temporal region. The SRM will be then monitored by video call occasionally for each participants on their respective time of treatment. Outcomes will be assessed at baseline, 2nd, 4th and 6th week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Young adults between 18-25 years of age.
2. Patients with any of the two following symptoms of TTH mentioned in the
international classification of headache disorders (ICHD-3).
a. Pain in bilateral location.
b. Pressing or tightening (non-pulsating) quality.
c. Mild or moderate intensity.
d. Not aggravated by daily activities like climbing stairs or walking.
3. Presence of tender points and trigger points in the peri-cranial, neck and upper back region. |
|
| ExclusionCriteria |
| Details |
1. Participants with neurological disorders, fibromyalgia, or systemic conditions that could affect headache or musculoskeletal symptoms.
2. Patients already undergoing TCA medication or any other physiotherapy for Tension type headache.
3. Individuals with significant psychiatric conditions (e.g., severe anxiety or depression) that might interfere with study outcome. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Two tools (a scale and a questionnaire/inventory) will be used to assess the outcome in this study.
1. Numeric Pain Rating Scale (NPRS)
2. Headache Disability Index (HDI)
|
Both NPRS and HDI:
Baseline (0 week)
Post treatment (4 Weeks)
and Follow up (6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale (NPRS)
2. Headache Disability Index (HDI) |
Interim (2nd Week) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2025 |
| 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)
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
|
This randomized controlled trial investigates the effect of the Neural Mobilization Technique (NMT) on pain and disability in young adults with Tension-Type Headache (TTH). Forty participants, aged 18-25, will be randomly assigned to either an NMT group, a self-relaxation massage (SRM) group, or a control group. The NMT group will receive specific cranio-cervical and mandibular mobilizations combined with self-relaxation techniques. The control group will be taught to perform SRM after initial application. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS) and disability through the Headache Disability Index (HDI). Assessments will occur at baseline, 2nd week (interim), 4 weeks post-intervention, and 6 weeks after. Data analysis will involve both categorical and continuous variables, with the results analyzed using appropriate statistical tests such as ANOVA for repeated measures or the Friedman test for non-parametric data, and independent t-tests or Mann-Whitney U tests where necessary as per the normality. Interim Analysis performed. (Intension to treat analysis specified). The study aims to determine whether NMT can significantly reduce pain and improve headache-related disability, offering a non-pharmacological treatment option for TTH. |