FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/11/059695 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 10/11/2023
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   The Effectiveness Of Dry Needling in Patients With Cervicogenic Headache. 
Scientific Title of Study   The Effectiveness of dry Needling on Pain, Disability, Sleep, Quality of life of patients with Cervicogenic Headache: A Randomized Control 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  Neha Nagar  
Designation  MPT student 
Affiliation  Delhi Pharmaceutical Sciences And Research University 
Address  Room NO-610, School of Physiotherapy, Delhi Pharmaceutical Sciences And Research University Sector-3 Pushp Vihar, M.B. Road, New Delhi

South
DELHI
110017
India 
Phone    
Fax    
Email  nehanaagar860@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Kalra 
Designation  Associate Professor 
Affiliation  Delhi Pharmaceutical Sciences And Research University 
Address  Delhi Pharmaceutical Sciences And Research University Sector-3 Pushp Vihar, M.B. Road, New Delhi-110017

South
DELHI
110017
India 
Phone  9990003410  
Fax    
Email  sheetalkalra@dpsru.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sheetal Kalra 
Designation  Associate Professor 
Affiliation  Delhi Pharmaceutical Sciences And Research University 
Address  Delhi Pharmaceutical Sciences And Research University Sector-3 Pushp Vihar, M.B. Road, New Delhi-110017

South
DELHI
110017
India 
Phone  9990003410  
Fax    
Email  sheetalkalra@dpsru.edu.in  
 
Source of Monetary or Material Support  
Delhi Pharmaceutical Sciences And Research University 
 
Primary Sponsor  
Name  Delhi Pharmaceutical Sciences And Research University  
Address  Delhi Pharmaceutical Sciences And Research University Sector-3 Pushp Vihar, M.B. Road, New Delhi-110017 
Type of Sponsor  Research institution 
 
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 Neha Nagar  Delhi Pharmaceutical Sciences And Research University   Delhi Pharmaceutical Sciences And Research University Sector-3 Pushp Vihar, M.B. Road, New Delhi-110017
South
DELHI 		 09555351335

nehanaagar860@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Students Research Development Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy Treatment  Total duration of Intervention would be 4 weeks, 3 session will be given per week. 
Intervention  Dry Needling  Total duration of Intervention would be 4 weeks, 3 session will be given per week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Both males and females between 18-30 years

2. Unilateral Headache without side shift

3. History of pain triggered by neck movement

4. Ipsilateral neck, shoulder, or arm pain.

5. Intermittent pain with episodes varying in
duration.

6. Patients who understand English and Hindi
languages
 
 
ExclusionCriteria 
Details  1. Use of anti-coagulation medicine (except
low-dose aspirin).

2. Acute or uncontrolled medical illness.

3. Pregnancy and use of any opioids within 6
months.

4. Presence of fever, vomiting, or visual
changes.

5. Fear of needle and needle phobia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain
Disability
Sleep
quality of Life 		 Baseline
2nd week
4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/11/2023 
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)
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.

  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 [nehanaagar860@gmail.com].

  6. For how long will this data be available start date provided 01-10-2023 and end date provided 01-10-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The aim of the study is to find out the effectiveness of  Dry Needling on pain, Disability of the head and neck, sleep, and Quality of life in patients with cervicogenic headache.
Procedure - Subjects will be invited to participate and participants will be explained about the study. subjects fulfilling the inclusion criteria. demographic details and baseline assessment will be taken before treatment, subjects will be asked to fill out the consent, and cervicogenic headache diagnostic criteria which is self-administered questionnaire will filled by the participants. pain assessment will be done by NPRS scale, Disability by NDI and HDI, sleep quality by PSQI and quality of life by EQ-5D-5L, Subjects will be divided into two groups group A  Dry needling with conventional physiotherapy treatment and group B  Conventional physiotherapy treatment and follow up baseline , after 2 weeks and 4th week then data analysis.
 
Close