- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249647
Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients
Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cervicogenic headache is a symptomatic headache characterized by chronic, hemi cranial pain syndrome in which pain sensations originates in cervical spine and soft tissues of the neck and basically referred to head. Cervicogenic headache originates in the upper cervical region, and the headache mechanism involves nociceptive structures such as the upper cervical spinal nerves, ganglia, disks, facet joints, muscles, and ligaments. Consequently, the anatomical structures innervated by cervical roots C1-C3 are potential sources of Cervicogenic headache.
Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) with the intention of restoring decrease pain, optimizing length and facilitating the release of fascial restrictions caused by injury, stress, repetitive use, etc. There are some studies about MFR and its effects which include: increase extensibilities of soft tissues, increase ROM, improves joint biomechanics, increases temperature of fascia, increases blood circulation to the muscles and decreases pain and muscles tone significantly.
Although; a lot of remedies such as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache, but sub-occipital MFR for Cervicogenic headache has not been studied specifically. Another technique used for cervicogenic headache includes Fascial Abrasion Technique tool that is a revolutionary tool that can quickly and effectively loosen muscle tissue/fascia. It improves range and quality of movement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sargodha,Punjab,Pakistan
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Sargodha, Sargodha,Punjab,Pakistan, Pakistan, 40100
- Warda Zafar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients having headaches with neck stiffness and pain.
- Headache for the past 3 months at least once per week.
- Positive flexion rotation test and restriction greater than 10°
- Patient aged 18-66 years old.
Exclusion Criteria:
- Headache not of cervical origin.
- Physiotherapy or chiropractic treatment in the past 3 months.
- Headache with autonomic involvement, dizziness and visual disturbance.
- Congenital conditions of Cervical spine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Instrument based fascial abrasion technique
IASTM using tools over Myofascial trigger points of the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes.
Participants were in a comfortable position during treatment.
Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application.
Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place & the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping.
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Participants were in a comfortable position during treatment.
Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application.
Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place & the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping.
Fascial Abrasion tool was washed in alcohol-based sanitizer before and after every treatment session and all norms of COVID-19 precautions were maintained.
Myofascial trigger points were marked with a 1×1 cm piece of tape/under wrap to confirm consistency of subsequent treatments.
Other Names:
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Active Comparator: Myofascial release technique
All participants will get Conventional therapy i.e heating pad for 10 minutes.
For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull.
This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks.
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All participants will get Conventional therapy i.e heating pad for 10 minutes.
For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull.
This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric pain rating scale for pain
Time Frame: 6 weeks
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Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
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6 weeks
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Neck disability index to measure functional status of neck
Time Frame: 6 weeks
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Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform.
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6 weeks
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Medical outcome study( MOS-36) to measure functions of daily living
Time Frame: 6 weeks
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Questionnaire consists of 11 questions regarding functions of daily living
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measuring tape for measuring ranges at cervical region
Time Frame: 6 weeks
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It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Sanaullah, MS, Study Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AH/21/0128/Warda Zafar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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