| CTRI Number |
CTRI/2024/11/077197 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| 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 Dural Tube Myofascial Release in Cervicogenic Headache: Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of Dural Tube Myofascial Release on Suboccipital Muscle Thickness,
Cervical Flexion-Rotation Range & Clinical
Metrics For Cervicogenic Headache: 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 |
Aarti Welling |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka, India
KLE Dr. Prabhakar Kore Hospital and MRC, Physiotherapy Department, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka, India
KLE Dr. Prabhakar Kore Hospital and MRC, Physiotherapy Department, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Welling |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka, India
KLE Dr. Prabhakar Kore Hospital and MRC, Physiotherapy Department, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Aarti Welling |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka, 590010, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Aarti Welling |
KLE Dr. Prabhakar Kore Hospital and MRC |
Department of Physiotherapy, Room no 18, Nehru Nagar, Belagavi, Karnataka, 590010, India
Belgaum
KARNATAKA |
9448814569
aartiwell88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dural Tube Release |
Dural Tube release given for a duration of 4 weeks on alternate days followed by SNAGs and Low Load Exercise |
| Comparator Agent |
SNAGs and Low Load exercise |
SNAGs will be given for 4 weeks on alternate days followed by home exercise protocol that is low load exercises for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with CGH based on the CHISG with a mandatory presentation of unilaterality of the head pain without side-shift associated with the neck pain and positive flexion-rotation test less then 33 degrees.31
2.All gender individuals aged 18-50 years.
3.Willingness to participate in the intervention while continuing to follow up for 12 weeks.
|
|
| ExclusionCriteria |
| Details |
1.Primary headache according to ICHD.9
2.Exhibiting any red flags for manual therapy15 like spinal infection, vertebral tumors or fracture, cervical instability, metabolic diseases, rheumatoid arthritis, osteoporosis, dizziness or visual disturbance symptoms, skin inflammatory condition, ulcers or wounds around treatment area.
3.Any medical or surgical conditions that prevents the participants from going in prone position as it is required for the intervention.
4.Taking prescribed analgesics or physiotherapy or any other allied therapies for the treatment of headache/ cervical pain/ or any other condition within 1 month.
5. Radiating pain in the upper extremity/neurological deficits to the upper extremities or known cases of cervical disc condition, arthritis of the cervical spine.
6.History of central nervous system involvement and vestibular dysfunction.
7.History of prior surgery to the head or neck.
8.Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Suboccipital Muscle thickness assessment using ultrasonography
2. Flexion Rotation Test |
Baseline and Post intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intensity, Duration and Frequency
2. Quality of life |
Baseline and Post Intervention (4 weeks, 6 weeks and 8 weeks) |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
18/12/2024 |
| 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="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
Cervicogenic headache (CGH) is commonly linked to physical impairments in the joints, muscles and neural structures of the cervical region, particularly the upper spine. Due to the referral of pain from the neck, CGH is frequently misdiagnosed and overlooked in individuals experiencing neck pain, leading to inadequate treatment. Physiotherapy is a safe and effective alternative, employing manual therapy techniques and highlighting the fascial concept to tackle neuro-musculoskeletal conditions linked to cervicogenic headaches. Various systematic reviews favour the use of sustained natural apophyseal glides (SNAGs) as a part of non-pharmacological management of cervicogenic headache. The clinical practice guidelines suggest that SNAGs and low load cervical exercises can be considered as a standard line of management for cervicogenic headache. However the potential effect of SNAGS and low load exercises on cervical muscle dysfunction visualized based on cervical muscle thickness in relation to the myodural bridge or dura using ultrasonography is seldom studied, there is also lack of supporting evidence considering the carry over effect of these techniques on the clinical metrics of cervicogenic headache. Application of Myofascial release (MFR) techniques like trigger point therapy and suboccipital release in reducing the intensity of CGH has been researched with positive outcomes. However none of these techniques targeted the dural tube that is a potential factor for CGH, that would have an impact on muscle thickness connecting the dural tube. Considering the dural tube being a major contributing factor for CGH which is linked through fascia of suboccipital muscles, the potential effect of fascial techniques like dural tube MFR that are specifically targeting the bridge and dura on clinical metrics (intensity, frequency, duration & severity) and muscle thickness is unknown and not explored. Thus it was hypothetized to determine and compare the effect of dural tube myofascial release with Sham release along with standard physical therapy care on suboccipital muscle thickness, cervical flexion-rotation range and clinical metric of headache in individuals with cervicogenic headache. |