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

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Instrument based Fascial abrasion technique
Myofascial release technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Neck and head pain

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warda Zafar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Instrument based fascial abrasion technique

Myofascial release technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measuring tape for measuring ranges at cervical region
It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)

Full Information

First Posted
February 1, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05249647
Brief Title
Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients
Official Title
Effects of Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Patients Having Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Neck and head pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instrument based fascial abrasion technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Myofascial release technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Instrument based Fascial abrasion technique
Other Intervention Name(s)
Instrument based soft tissue release technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release technique
Other Intervention Name(s)
Soft tissue release technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric pain rating scale for pain
Description
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
Time Frame
6 weeks
Title
Neck disability index to measure functional status of neck
Description
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform.
Time Frame
6 weeks
Title
Medical outcome study( MOS-36) to measure functions of daily living
Description
Questionnaire consists of 11 questions regarding functions of daily living
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Measuring tape for measuring ranges at cervical region
Description
It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Sanaullah, MS
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warda Zafar
City
Sargodha
State/Province
Sargodha,Punjab,Pakistan
ZIP/Postal Code
40100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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