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CTRI Number  CTRI/2024/05/067419 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
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   Assessing Slump Mobilizations Impact on Pain, Range of Motion and Quality of Life in Cervicogenic Headache: A Randomized Controlled Trial 
Scientific Title of Study   Efficacy of Slump Mobilization in improving pain, range of motion and quality of life in individuals 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  Sukhpreet Kaur 
Designation  MPT Student 
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Room no 06, General OPD, Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be university,mullana, Ambala Haryana 133203

Ambala
HARYANA
133203
India 
Phone  9855923440  
Fax    
Email  supreet.kaur1222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akanksha Saxena 
Designation  Assistant professor 
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Room NO 06, General OPD, Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be university,mullana, Ambala Haryana 133203

Ambala
HARYANA
133203
India 
Phone  7906989678  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr Akanksha Saxena 
Designation  Assistant professor 
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Room no 06, General OPD, Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be university,mullana, Ambala Haryana 133203

Ambala
HARYANA
133203
India 
Phone  7906989678  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Sukhpreet Kaur 
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be university 
Type of Sponsor  Other [Other [Self]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akanksha Saxena  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Room no 06, General OPD
Ambala
HARYANA 		 7906989678

akankshasaxena623@mmumullana.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Science and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G542||Cervical root disorders, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional agent  Myofascial Release: Administered in supine lying position, a towel roll is placed under the patients head. The therapist then applies pressure with three middle fingers just below the nuchal line to release fascia. Each session lasts 3-4 minutes. Sustained Natural Apophyseal Glides (SNAGs): Conducted in a sitting position, the therapist holds the patients head with one hand while using the thenar eminence and ring finger of the other hand to provide a prolonged glide in an upward direction (45 degrees) to the cervical vertebraes spinous process. This is repeated for 3 reps x 5 sets with each hold lasting 3-10 seconds.This treatment is given for 4 days a week for 4 weeks 
Intervention  Slump mobilization and Conventional Treatment  Myofascial Release: Administered in supine lying position, a towel roll is placed under the patients head. The therapist then applies pressure with three middle fingers just below the nuchal line to release fascia. Each session lasts 3-4 minutes. Sustained Natural Apophyseal Glides (SNAGs): Conducted in a sitting position, the therapist holds the patients head with one hand while using the thenar eminence and ring finger of the other hand to provide a prolonged glide in an upward direction (45 degrees) to the cervical vertebraes spinous process. This is repeated for 3 reps x 5 sets with each hold lasting 3-10 seconds. Slump mobilization: Performed in a high sitting position, the patient is asked to sit in a slump position. The therapist extends the patients knee while simultaneously instructing the patient to extend the neck. Then, the therapist passively flexes the knee while the patient flexes the neck. This is repeated for 2 minutes with a rhythm of 30-40 repetitions per session, followed by a one-minute break, and then repeated for two more times. Duration for the treatment: This treatment is given for 3 days a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Age 18 to 45 years
Both males and females
Individuals with Cervicogenic Headache as diagnosed by International Study Group Criteria ( CHISG )
Individuals with Numeric Pain Rating Scale (NPRS) score more than 2
Individuals with Neck Disability Index (NDI) score than 20 percentage 
 
ExclusionCriteria 
Details  Individuals having headache due to migraine.
Individuals having any fracture of cervical spine, osteoporosis, cervical stenosis, tumor, uncontrolled hypertension, prolonged use of steroid.
Individuals with history of whiplash injury.
Past surgical interventions.
Pregnant and breastfeeding individuals with cervicogenic headache.
Individuals who received any chiropractic and physiotherapy treatment within the previous month 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Headache Impact test-6(HIT-6)
Pain Pressure Threshold-Algometer
Universal Goniometer 		 Baseline, 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
SF-36 Questionnaire  Baseline & Post intervention(at end of 4th week) 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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/ Phase 3 
Date of First Enrollment (India)   03/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [supreet.kaur1222@gmail.com].

  6. For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Subjects will be selected based on specific criteria and then assessment will be done by using primary and secondary outcome measures, and participants then randomly assigned to either Group 1 (receiving Slump Mobilization and Conventional treatment) or Group 2 (receiving Conventional treatment only) using computer-based random allocation techniques.

During Myofascial Release, patients lie supine with a towel roll under their head while the therapist applies pressure with three fingers below the nuchal line to release fascia for 3-4 minutes per session. In SNAGs, patients sit while the therapist provides prolonged glides upward to the cervical vertebrae’s spinous process for 3 reps x 5 sets, with each hold lasting 3-10 seconds. Slump mobilization is conducted with patients in a high sitting position, where they are asked to sit in a slump position while the therapist extends and flexes their knee, instructing the patient to correspondingly extend and flex the neck. This is repeated for 2 minutes with a rhythm of 30-40 repetitions per session, followed by a one-minute break, and then repeated for two more times.

 
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