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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05249647
Collaborator
(none)
44
1
2
5.6
7.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Instrument based Fascial abrasion technique
  • Other: Myofascial release technique
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Jul 13, 2022
Anticipated Study Completion Date :
Jul 13, 2022

Arms and Interventions

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.

Other: Instrument based Fascial abrasion technique
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.

    Other: 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.
    Other Names:
  • Soft tissue release technique
  • Outcome Measures

    Primary Outcome Measures

    1. Numeric pain rating scale for pain [6 weeks]

      Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable

    2. Neck disability index to measure functional status of neck [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.

    3. Medical outcome study( MOS-36) to measure functions of daily living [6 weeks]

      Questionnaire consists of 11 questions regarding functions of daily living

    Secondary Outcome Measures

    1. Measuring tape for measuring ranges at cervical region [6 weeks]

      It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warda Zafar Sargodha Sargodha,Punjab,Pakistan Pakistan 40100

    Sponsors and Collaborators

    • Riphah International University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05249647
    Other Study ID Numbers:
    • REC/RCR&AH/21/0128/Warda Zafar
    First Posted:
    Feb 22, 2022
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 22, 2022