| CTRI Number |
CTRI/2024/05/067054 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness Of Joint Mobilization And Kinesiotaping Along With Neck Exercises On Pain, Range Of Motion And Endurance In Patient With Cervicogenic Headache |
|
Scientific Title of Study
|
Effectiveness Of Cervical Mobilization And Kinesotaping Along With Cervical Stabilization Exercises On Pain Range Of Motion And Endurance of Deep Neck Flexors Muscles In Participants With Cervicogenic Headache A Single Blinded 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 |
DrAnushka Rajesh Loharkar |
| Designation |
MPT First year Musculoskeletal sciences |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmednagar
MAHARASHTRA 414111 India Ahmednagar MAHARASHTRA
414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9322218915 |
| Fax |
|
| Email |
anushkaloharkar2831@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anushka Rajesh Loharkar |
| Designation |
MPT First year Musculoskeletal sciences |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmednagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9322218915 |
| Fax |
|
| Email |
anushkaloharkar2831@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Anap |
| Designation |
HOD Musculoskeletal sciences |
| Affiliation |
D V V P Fs College of Physiotherapy |
| Address |
Department of Musculoskeletal physiotherapy basement Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar Ahmednagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of musculoskeltal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
MAHARASHTRA 414111 India |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
Department of musculoskeletal sciences Block 1 basement DVVPFs
college of physiotherapy Oppo Govt Milk Dairy MIDC 414111
Ahmadnagar MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
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 Anushka Loharkar |
D V V P Fs College of Physiotherapy |
Department of Musculo
skeletalsciences Opp
Govt Milk Dairy M I D C
Ahmednagar 414111
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
9322218915
anushkaloharkar2831@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committee Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical Mobilization with Cervical Stabilization Exercises |
Following are the types of exercises given to the patients
1.Chin tucks in supine
2.Chin tuck in supine with shoulder flexion
3.Chin tucks in prone on elbow
4.Chin tucks in quadruped position with alternate shoulder flexion
5.Chin tucks in quadruped position with alternate Shoulder flexion and leg extension
6.Chin tucks in standing with shoulder abduction with TheraBand
7.Small Swiss ball hold against the wall with chin tucks with shoulder flexion with TheraBand
The exercises are given for 10 repetitions / 2 sets / twice a day.
After cervical stabilization exercises, the patients will get Cervical Mobilization.
The patient will be in sitting position and therapist will be standing behind the patient. Examiner will place the thumb on the spinous process of the C1-C2. Therapist then move the spinous process upward towards eyeball direction and maintain this glide and ask the patient to turn (rotation) his head slowly in restricted painful direction, sustain the mobilization until head returns to the midline. Four repetitions of each glide were given and were maintained for 10 seconds at end range or the onset of pain.
|
| Intervention |
Kinesotaping along with Cervical Stabilization |
Following are the types of exercises given to the patients
1.Chin tucks in supine
2.Chin tuck in supine with shoulder flexion
3.Chin tucks in prone on elbow
4.Chin tucks in quadruped position with alternate shoulder flexion
5.Chin tucks in quadruped position with alternate Shoulder flexion and leg extension
6.Chin tucks in standing with shoulder abduction with TheraBand
7.Small Swiss ball hold against the wall with chin tucks with shoulder flexion with TheraBand
The exercises are given for 10 repetitions / 2 sets / twice a day.
The patient will be in sitting position and therapist will be standing behind the patient. Examiner will apply KT on upper fibres of trapezius and deep cervical extensors muscles. The tape will be kept in place and changed weekly. It is applied on deep cervical extensors by measuring the distance between the occipital union and T4/T5 cervical vertebrae; two pieces of the tape is cut in a Y shape equal to this distance. The base will be fixed at T4/T5, and the two strips of the tape will run along the spine, one on the right side and the other on the left side. Patients will be then asked to flex the cervical vertebrae (maximum flexion) while making a heterolateral rotation of the head, and the tape was stretched, and the anchor will fix below the occipital union. We then put pressure by the knuckles on the tape to stimulate its adhesive effect. For the upper fibres of the trapezius, we will measure the distance between the acromion processes and the occipital union. We cut two pieces of tape equal to this distance. We will start by fixing the base of the tape on the origin of upper fibres of the trapezius. Then, the patients will be asked to laterally flex the neck (maximum side bending), and we will fix the anchor at the insertion in the acromion process. We will then put pressure by the knuckles on the tape to stimulate its adhesive effect. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age - 20-40 years,
Unilateral or a side-dominant headache without side shift
Had at least one episode of cervicogenic Heachaches in previous 3 months.
Positive flexion-rotation test and restriction greater than 10°
|
|
| ExclusionCriteria |
| Details |
A headache not of cervical origin.
Physiotherapy or chiropractic treatment in the past 3 months for the same problem
A headache with autonomic involvement, dizziness, or visual disturbance.
Congenital conditions of the cervical spine.
Contraindication to manual therapy.
Inability to tolerate the flexion-rotation test
Unwilling to participate in the study
Any allergies to Kinesotaping
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of motion, Endurance ,Quality of life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of motion, Endurance ,Quality of life |
3 Weeks |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
20/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The study is to see Effectiveness Of Cervical Mobilization And Kinesotaping Along With Cervical Stabilization Exercises On Pain, Range Of Motion And Endurance of Deep Neck Flexors Muscles In Participants With Cervicogenic Headache : A Single Blinded Randomized Control Trial. 14 subjects - 07 in each group will be recruited based on inclusion and exclusion criteria. There will be 2 groups, Cervical Mobilization and Kinesotaping Along With Cervical Stabilization Exercises will be given to each group for 3 weeks. Total treatment protocol will be of 3 weeks. Intervention should be given five times a week upto 3 weeks. Data will be analyzed statistically |