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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06197542
Other study ID # RCRAHS-ISB/REC/MS-PT/015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2023
Est. completion date November 15, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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. .

Locations

Country Name City State
Pakistan Gulberg green campus of Riphah International University Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rate Scale: Numeric Pain Rate Scale used to measure pain intensity. 3rd week
Primary Cervical Goniometer Cervical Goniometer used to assess cervical ranges. 3rd week
Secondary HIT-6 Headache Impact Test The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. 3rd week
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