| CTRI Number |
CTRI/2025/07/091239 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of PNF Therapy on pain and sleep quality in people with cervicogenic headache |
|
Scientific Title of Study
|
Effects of Proprioceptive Neuromuscular Facilitation on Pain, Neck Proprioception, and Sleep Quality in Individuals with Cervicogenic Headache. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Kumar |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No. 1, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA
133207
India |
| Phone |
9472857435 |
| Fax |
|
| Email |
prashant280898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanika |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No. 1, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA
133207
India |
| Phone |
7015597126 |
| Fax |
|
| Email |
kanika.k160@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Neuro OPD, Ground Floor, Room No. 1, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA
133207
India |
| Phone |
7015597126 |
| Fax |
|
| Email |
kanika.k160@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurophysiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Medical Sciences and Research, Maharishi Markandeshwar (deemed to be university), Mullana, Ambala, Haryana 133207 |
|
|
Primary Sponsor
|
| Name |
Prashant Kumar |
| Address |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, Neuro OPD Ground Floor Room NO. 1, MMDU, MULLANA, AMBALA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kanika |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, Neuro OPD Ground Floor Room NO. 1, MMDU, MULLANA, AMBALA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Neuro OPD, Ground Floor, Room No. 1, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana - 133207, India
Ambala
HARYANA |
9472857435
prashant280898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
Proprioceptive Neuromuscular Facilitation (PNF) techniques included diagonal movement specifically included patterns known as D1 and D2 for neck, Alongside these patterns, we will apply techniques such as Hold-Relax (where a muscle is gently held against resistance before being stretched), Contract-Relax (which involves moving the muscle before stretching), and Rhythmic Stabilization (where muscles are challenged to hold steady against gentle pressure from different directions).The total duration of the intervention will be 4 weeks, with sessions conducted 3 times per week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-35 years
Both males and females
Patient having cervicogenic headache as diagnosed by International Study Group Criteria (CHISG)
|
|
| ExclusionCriteria |
| Details |
Subjects with recent history of surgery of Brain
Traumatic Neck Injury
Patient who has undergone physiotherapy intervention within last 3 months
Individuals having headache due to migraine.
Individuals having any fracture of cervical spine, osteoporosis, cervical stenosis, tumor, uncontrolled hypertension, prolonged use of steroid.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache Impact Test-6 (HIT-6)
Cervical Joint Position error test (JPET)
Pittsburg Sleep Quality Index (PSQI) |
Baseline, Post-intervention (6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="8"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Cervicogenic headache, originating from cervical spine dysfunction, significantly impact individuals’ quality of life. Proprioceptive Neuromuscular Facilitation (PNF) is a therapeutic technique that may enhance proprioception, balance, and overall well-being. This study investigates the effects of PNF on pain, neck proprioception, and sleep quality in individuals with cervicogenic headache. To investigate the effects of Proprioceptive Neuromuscular Facilitation (PNF) on Pain, Neck proprioception and sleep quality in individuals suffering from cervicogenic headache. Total 36 patients will be recruited on the basis of inclusion and exclusion criteria. Subjects will be allocated in Experimental group (a single group pre – post design) with purposive sampling technique. Outcome measure will be assessed at two time points: Baseline and Post- Intervention (Immediately after the completion of Six-week PNF treatment). The PNF techniques will include PNF patterns of neck and techniques including rhythmic stabilization, contract-relax and hold-relax, targeting the cervical region and associated musculature. Pain will be assessed by Headache Impact Test-6 (HIT-6), Neck proprioception will be evaluated using a repositioning error test, and sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Participants will undergo PNF treatment for 30 minutes, three times a week for six weeks. |