Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine

NCT ID: NCT06197542

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-11-15

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.

Detailed Description

Migraine is a neurological condition that typically causes painful headache attacks lasting from four to 72 hours that occur with additional symptoms, such as sensitivity to light, sound, smell, or touch. Migraines occur most frequently in the morning, especially upon waking. Migraines can be triggered by stress or hormones. Migraine attacks are debilitating and can hinder the day to day activities and productivity of the patient. The purpose of the study was to evaluate the effects of active release technique and instrument assisted soft tissue mobilization on trigger points. It was a randomized, controlled trial, conducted among migraine patients. Sample size was 54 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope.All participants in both groups were evaluated on baseline and post-intervention.

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Release Technique

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.

Group Type: EXPERIMENTAL

Active Release Technique

Intervention Type: OTHER

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.

Instrument Assisted Soft Tissue Mobilization

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.

Group Type: EXPERIMENTAL

Instrument Assisted Soft Tissue Mobilization

Intervention Type: OTHER

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. .

Interventions

Active Release Technique

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.

Intervention Type: OTHER

Instrument Assisted Soft Tissue Mobilization

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. .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramsha Tariq, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Gulberg green campus of Riphah International University

Islamabad, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 25600719 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35281991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17244105 (View on PubMed)

Other Identifiers

RCRAHS-ISB/REC/MS-PT/015

Identifier Type: -

Identifier Source: org_study_id