| CTRI Number |
CTRI/2025/05/086133 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Muscle Tension Inhibition technique plus Muscular Relaxation method on Tension Type Headache |
|
Scientific Title of Study
|
EFFECT OF SUB-OCCIPITAL TIOSSUE INHIBITION AND PROGRESSIVE MUSCULE RELAXATION ON TENSION TYPE HEADACHE |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University |
| Address |
Chinar Bagh, Near Punjabi University, (Deptt. of Physiotherapy) Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802490 |
| Fax |
0175 |
| Email |
sandyraina248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ishika Garg |
| Designation |
Post graduate student |
| Affiliation |
From Punjabi University |
| Address |
House no. 1034, near shyam hospital, Prem nagar, Kotkapura , Dist. Faridkot
Faridkot
PUNJAB
151204
India |
| Phone |
8054266631 |
| Fax |
|
| Email |
gargishika918@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University |
| Address |
Chinar Bagh, Near Punjabi University, (Deptt. of Physiotherapy) Patiala
PUNJAB
147001
India |
| Phone |
9417802490 |
| Fax |
0175 |
| Email |
sandyraina248@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sandeep Singh, Assistant professor, Punjabi University, Patiala (147002), INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Singh |
| Address |
(Assisstant Professor in Punjabi University), Chinar Bagh, Patiala 147001, PUNJAB |
| Type of Sponsor |
Other [research guide] |
|
|
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 |
Punjabi University, Out patient department, |
dept. of physiotherapy, Punjabi University, 147001
Patiala
PUNJAB |
09417802490
sandyraina248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Punjabi University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tension type Headache |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Progressive Muscle Relaxation (APMR) |
APMR relieves full body muscle tension and induces relaxation 20 min/day, on alternate days twice a week for 4 weeks |
| Intervention |
Sub Occipital Tissue Inhibition (SOTI) and Abbreviated Progressive Muscle Relaxation (APMR) |
SOTI is a manual release technique for the suboccipital area, APMR is general body relaxation- 15 min /day on alternate days for twice a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
1. Suffering from mild to moderate intensity pain
2. The pain located bilaterally over the temporal region.
3. pressing, non-pulsating type of pain
4. Headache not aggravated by normal physical activity
5. Only one out of photophobia or phonophobia should be present and not both.
6. At least 10 episodes of headache occurring for 1-14days/month on average for >3 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients with infrequent TTH
2. Headache that is aggravated by head movements
3. Previous neck trauma
4. Individuals with history of metabolic or systemic disorders like vertigo, dizziness, hypertension /hypotension.
5. Patients with cardiac devices
6. Neurological alterations or pre diagnosed neurological disease
7. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache Disability Index (HDI)
Visual Analogue Scale (VAS) |
DAY 0 and DAY 28, at baseline and at end of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline
week 4 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/05/2025 |
| 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="0"
Months="3"
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
|
Tension type headache is very prevalent in young adults, mainly caused due to muscular factors or pyschomyogenic factors thus physiotherapy treatment would aim at reducing the tension in the sub occipital musculature and progressive muscle relaxation would help in full body relaxation. The study is aimed to review the effect of sub-occipital tissue musculature and progressive muscle relaxation on individuals with frequent tension type headache |