NCT06197542

Brief Summary

Rationale of this research is to evaluate the outcome of active release technique and Instrument assisted soft tissue mobilization on trigger points in subjects with Migraine. The significance of this study is to identify which technique is superior in alleviating the symptoms of migraine. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of Migraine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 26, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Trigger points,Active release Technique,IATSM

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rate Scale:

    Numeric Pain Rate Scale used to measure pain intensity.

    3rd week

  • Cervical Goniometer

    Cervical Goniometer used to assess cervical ranges.

    3rd week

Secondary Outcomes (1)

  • HIT-6 Headache Impact Test

    3rd week

Study Arms (2)

Active Release Technique

EXPERIMENTAL

Individuals in Group A will be subjected to Heat Therapy over the targeted muscles via hot pack for 5 minutes in every session along with passive stretching for 5 minutes Group A will receive Active release technique on targeted muscles. The participant was comfortably seated and rested the forehead on the forearms .To apply for the release, the active TrP was identified, and sustained and constant pressure was applied. For stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck.The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week.

Other: Active Release Technique

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

Group A will be subjected to Heat Therapy for 5minutes along with Stretching for 5 minutes .Group B will be Subjected to IASTM using M2T blade for approximately 3 minutes per muscle. Lubricant was applied and the tool was cleaned with an alcohol pad.the tool was used to locate soft tissue restrictions in the muscles. Then, the therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin Treatment time was 3 minutes. Cryotherapy was applied for 10 minutes after the session. The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week.

Other: Instrument Assisted Soft Tissue Mobilization

Interventions

active TrP was identified, and sustained and constant pressure was applied .for stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck.

Active Release Technique

The therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin. .

Instrument Assisted Soft Tissue Mobilization

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female 18-30 years Trigger points in Trapezius , Sternocleidomastoid and Sub-occipitals (Identified using Travel and Simmons Criteria) Migraine without Aura Subjects were cognitively capable and competent to follow the instructions

You may not qualify if:

  • Dysfunctions in the temporomandibular joint. Participant with a history of basilar migraine or hemiplegic migraine Fracture of Cervical Spine Currently on Medication for Migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulberg green campus of Riphah International University

Islamabad, Punjab Province, 44000, Pakistan

Location

Related Publications (3)

  • Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.

    PMID: 25600719BACKGROUND
  • Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.

    PMID: 35281991BACKGROUND
  • Garcia-Leiva JM, Hidalgo J, Rico-Villademoros F, Moreno V, Calandre EP. Effectiveness of ropivacaine trigger points inactivation in the prophylactic management of patients with severe migraine. Pain Med. 2007 Jan-Feb;8(1):65-70. doi: 10.1111/j.1526-4637.2007.00251.x.

    PMID: 17244105BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ramsha Tariq, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers who evaluated the participants were not informed of how the participants were grouped. Participants were informed that they would receive one of two different interventions without indicating which group should undergo trunk stability or conventional physiotherapy program.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to the A group or B group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled \"Group A\" or \"Group B.\" Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

April 10, 2023

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations