Clinical trial NCT06504537: Comparative Effects of Theragun Percussion Therapy and Compression Therapy in The Patients With Migraine
Official title: Comparative Effects of Theragun Percussion Therapy and Compression Therapy on Pain, Neck Range of Motion and Quality of Life in The Patients With Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: neck stiffness
headache
PNF
strteching
compression therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of Theragun Percussion therapy and Compression Therapy on pain, neck range of motion and quality of life in the patients with Migraine

Detailed description: Migraine is a type of unilateral headache characterized by recurrent attacks of moderate to severe pulsating pain which common symptoms include increased sensitivity to light, noise, nausea and vomiting. Mechanical scalp compression is the most commonly used for temporary relief of migraine pain that originates from dilated blood vessels in the scalp. Many percussive therapy devices are used for relax and soothe sore muscles as Theragun helps in instant relief migraine pain.

It will be a Single blinded randomized clinical trial. Non-probability convenience sampling technique will be used to recruit 56 participants of 18 to 50 years of age from Riphah Rehabilitation Care Centre and Sir Ganga Ram Hospital, Lahore. The participants will be then randomly assigned into two equal groups through random number generation table. In Group A, Percussion Therapy will be applied by Theragun device for 25 minutes in each session along with Routine Physical Therapy Treatment for 20 minutes. In Group B, the Compression Therapy will be applied by migraine relief Gel Cap which works as Compression device for head for 25 minutes in each session along with Routine Physical Therapy Treatment for 20 minutes. The treatment will be given for 5 times per week for 6 weeks. Outcome measures for pre and post evaluation will be Visual Analogue Scale (VAS) for pain assessment, Migraine Screening Quality of life Questionnaire (MS-Q) for quality of life, Neck Disability Index (NDI) for neck disability, Bubble Inclinometer for neck range of motion. The data will be analyzed using SPSS version 24.

Eligibility criteria: Inclusion Criteria:

1. Both Genders
2. 18 to 65 years' old
3. Migraine without Aura
4. Headache with nausea or vomiting and light/sound sensitivity
5. Unilateral Headache from past 3 months at least once a week
6. ICHD-3 Criteria of migraine

Exclusion Criteria:

1. Congenital Condition of cervical spine
2. Inability of neck to perform flexion-rotation test
3. Meningitis, deep vein thrombosis
4. other-type of headache
5. Headache attributed to trauma or injury to neck

Primary outcomes:
measure: International Classification of Headache Disorders (ICHD-3)
timeFrame: 6 weeks
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 6 weeks
measure: Migraine Screening Quality of Life Questionnaire (MS-Q)
timeFrame: 6 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 6 weeks
Other outcomes:
measure: Bubble Inclinometer
timeFrame: 6 weeks
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: hira jabeen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly DP, Strauss AW. Inherited cardiomyopathies. N Engl J Med. 1994 Mar 31;330(13):913-9. doi: 10.1056/NEJM199403313301308. No abstract available.
citation: Ferrari MD, Goadsby PJ, Burstein R, Kurth T, Ayata C, Charles A, Ashina M, van den Maagdenberg AMJM, Dodick DW. Migraine. Nat Rev Dis Primers. 2022 Jan 13;8(1):2. doi: 10.1038/s41572-021-00328-4.
citation: Andreou AP, Edvinsson L. Mechanisms of migraine as a chronic evolutive condition. J Headache Pain. 2019 Dec 23;20(1):117. doi: 10.1186/s10194-019-1066-0.
citation: Allen SM, Mookadam F, Cha SS, Freeman JA, Starling AJ, Mookadam M. Greater Occipital Nerve Block for Acute Treatment of Migraine Headache: A Large Retrospective Cohort Study. J Am Board Fam Med. 2018 Mar-Apr;31(2):211-218. doi: 10.3122/jabfm.2018.02.170188.
citation: Wanderley D, Valenca MM, de Souza Costa Neto JJ, Martins JV, Raposo MCF, de Oliveira DA. Contract-relax technique compared to static stretching in treating migraine in women: A randomized pilot trial. J Bodyw Mov Ther. 2020 Apr;24(2):43-49. doi: 10.1016/j.jbmt.2019.05.023. Epub 2019 May 22.
citation: Nasb M, Qun X, Ruckmal Withanage C, Lingfeng X, Hong C. Dry Cupping, Ischemic Compression, or Their Combination for the Treatment of Trigger Points: A Pilot Randomized Trial. J Altern Complement Med. 2020 Jan;26(1):44-50. doi: 10.1089/acm.2019.0231. Epub 2019 Oct 3.