Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients

December 9, 2022 updated by: Riphah International University

Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache

Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.

Study Overview

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

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sargodha,Punjab,Pakistan
      • Sargodha, Sargodha,Punjab,Pakistan, Pakistan, 40100
        • Warda Zafar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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:
  • Instrument based soft tissue release technique
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.
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:
  • Soft tissue release technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale for pain
Time Frame: 6 weeks
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
6 weeks
Neck disability index to measure functional status of neck
Time Frame: 6 weeks
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform.
6 weeks
Medical outcome study( MOS-36) to measure functions of daily living
Time Frame: 6 weeks
Questionnaire consists of 11 questions regarding functions of daily living
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring tape for measuring ranges at cervical region
Time Frame: 6 weeks
It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Muhammad Sanaullah, MS, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Actual)

July 13, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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