NCT05249647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

February 1, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

Neck and head pain

Outcome Measures

Primary Outcomes (3)

  • 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

    6 weeks

  • 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.

    6 weeks

  • Medical outcome study( MOS-36) to measure functions of daily living

    Questionnaire consists of 11 questions regarding functions of daily living

    6 weeks

Secondary Outcomes (1)

  • Measuring tape for measuring ranges at cervical region

    6 weeks

Study Arms (2)

Instrument based fascial abrasion technique

EXPERIMENTAL

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

Myofascial release technique

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Instrument based soft tissue release technique
Instrument based fascial abrasion 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.

Also known as: Soft tissue release technique
Myofascial release technique

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warda Zafar

Sargodha, Sargodha,Punjab,Pakistan, 40100, Pakistan

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadache

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Muhammad Sanaullah, MS

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 22, 2022

Study Start

January 25, 2022

Primary Completion

July 13, 2022

Study Completion

July 13, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations