Clinical trial NCT06197542: Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine
Official title: Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Keywords: Trigger points,
Active release Technique,
IATSM
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 \&quot;Group A\&quot; or \&quot;Group B.\&quot; 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rate Scale:
timeFrame: 3rd week
measure: Cervical Goniometer
timeFrame: 3rd week
Secondary outcomes:
measure: HIT-6 Headache Impact Test
timeFrame: 3rd week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Gulberg green campus of Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ramsha Tariq, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.