| CTRI Number |
CTRI/2019/05/019401 [Registered on: 28/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2019 |
| 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
|
A clinical trial to study the effects of dry Needling and manual Therapy for the Management of Patients with Cervicogenic Headache. |
|
Scientific Title of Study
|
Dry Needling and Manual Therapy for the Management o Cervicogenic Headache. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh Chandra Patra |
| Designation |
Ph.D Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University.School Of Physiotherapy and paramedical science, Physiotherapy Department, Block no-3A, Room No-105
Same
Kapurthala
PUNJAB
144411
India |
| Phone |
9653174563 |
| Fax |
|
| Email |
rameshbmc22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Chandra Patra |
| Designation |
Ph.D Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University.School Of Physiotherapy and paramedical science, Physiotherapy Department, Block no-3A, Room No-105
Same
Kapurthala
PUNJAB
144001
India |
| Phone |
9653174563 |
| Fax |
|
| Email |
rameshbmc22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Chandra Patra |
| Designation |
Ph.D Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University.School Of Physiotherapy and paramedical science, Physiotherapy Department, Block no-3A, Room No-105
264, defense colony, Jalandhar, Punjab
Kapurthala
PUNJAB
144411
India |
| Phone |
9653174563 |
| Fax |
|
| Email |
rameshbmc22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jalandhar Delhi GT road,
Out Patient Department (OPD), Department of Physiotherapy, Lovely Professional
University, Phagwara, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Ramesh Chandra Patra |
| Address |
264, defense colony, Jalandhar, Punjab |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Nandini Verma |
Lovely Professional University, Punjab, India. |
School of Physiotherapy and Paramedical sciences, Department of Physiotherapy, Block-3A, Room no- 105.
Kapurthala
PUNJAB |
7807564403
nandini.24453@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTUTUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G894||Chronic pain syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry needling and Manual therapy |
Dry needling: Acupuncture needle was used (15 mm for suboccipital muscle and 40 mm was used for trapezious muscle).Two Sessions per week for four weeks
Manual therapy: C1-C2 Mulligan SNAGs were performed and maintained the glide for 10 second and repeat the procedure for 6-10 times.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Based on the following conditions the individuals are included in the study:
1. Both male and female with the age group of 20-50 years.
2. Persons fulfilling the diagnostic criteria given by IHS (international
headache society.
3. Positive FRT (flexion-rotation test) and restricted ROM. |
|
| ExclusionCriteria |
| Details |
Following participants were excluded from the study:
1. Cervical spine injury, fracture or surgery.
2. Congenital spinal deformity.
3. The participants not meeting age criteria for inclusion.
4. Cervical radiculopathy or presenting neurological deficit.
5. Participants with history of recent trauma.
6. Participants suffering from dizzy spells.
7. Vertebral malignancy.
8. Vertebral-basilar insufficiency.
9. Bone infections.
10 Any participants who were taking anti-inflammatory or muscle relaxant
medication were excluded.
11. Any participants who failed to comply with the consent form were excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective outcome measures:
 Pain (Numerical Pain Rating scale).
Quality of life (QOL Questionnaire)
Headache disability index (HDI questionnaire)
Objective outcome measures:
Tenderness (PPT Algometer)
Cervical range of motion |
Before and After the treatment( duration is 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
NA |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
30/05/2019 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The cause of CGH is
thought to lie in any of the structures that are innervated by the first three cervical
nerves. This study examines about the dry needling and manual therapy for the
management of patient with Cervicogenic Headache. As previous studies fails to
investigate about the dry needling and manual therapy for the management of
patient with Cervicogenic Headache, this study intends to discuss in detail about
the proposed topic and also proposes the model. This study will help the future
researchers to know about how dry needling and manual therapy helps in the
management of patient with Cervicogenic Headache as combined modality.
Analyzing the existing researches, this research aims to provide a clear overview easy
management
of
cervicogenic
headache. Effects of dry
needling and
manual therapy
Improvement in headache
disability index ,Improved range of motion ,Improved quality of life, reduce pain and tenderness for the management of patient with
Cervicogenic Headache. |