Comparative Effects of Theragun Percussion Therapy and Compression Therapy in The Patients With Migraine

NCT ID: NCT06504537

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-30

Brief Summary

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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

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the study would be single blinded as the assessor of the study would be kept blind.

Study Groups

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GROUP A: THERAGUN PERCUSSION THERAPY AND ROUTINE PHYSICAL THERAPY

Patients will receive Theragun Percussion Therapy for 25 minutes along with Routine Physical Therapy Treatment for 20 minutes

Group Type EXPERIMENTAL

THERAGUN PERCUSSION THERAPY

Intervention Type OTHER

In Group A, Patients will receive Theragun Percussion therapy along with routine Physical Therapy Treatment. The range of motion of lateral flexion and forward flexion will take by using a bubble inclinometer. Then the patient will place in a sitting position with the shoulder area exposed. Percussion therapy by using the Theragun device will give by a specific order. Treatment will start with the percussion head applied at the origin and insertion heads of the trapezius, Rhomboid and scalene muscle for 3-4 minutes each. Following this the percussive Theragun applicator will applied with circular strokes along the length of the muscle for 3 minutes. The pressure of application will adjust to the subject's tolerance.

GROUP B: COMPRESSION THERAPY AND ROUTINE PHYSICAL THERAPY

Compression therapy will be administered to the patients by migraine relief gel cap for 25 minutes during migraine attacks along with Routine Physical Therapy Treatment for 20 minutes.

Group Type EXPERIMENTAL

COMPRESSION THERAPY

Intervention Type OTHER

In Group B, Compression therapy will be administered to the patients by migraine relief gel cap for 25 minutes during migraine attacks. The cap will store in a freezer (15-18°C). At the onset of the migraine attacks, patients wore the cap and used it. We will choose 25 minutes as the time for application of the gel cap based on the results of two published studies.(23) Headache severity will measured by Visual Analogue Scale and pain relief will measured on a similar scale. Analgesic treatment will not take within 25 minutes after the onset of cold therapy. If patients did not experience adequate relief from the headache, we will allow them to use analgesics 25 minutes after the onset of cold therapy. The routine physical treatment will be same as in group A.

Interventions

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THERAGUN PERCUSSION THERAPY

In Group A, Patients will receive Theragun Percussion therapy along with routine Physical Therapy Treatment. The range of motion of lateral flexion and forward flexion will take by using a bubble inclinometer. Then the patient will place in a sitting position with the shoulder area exposed. Percussion therapy by using the Theragun device will give by a specific order. Treatment will start with the percussion head applied at the origin and insertion heads of the trapezius, Rhomboid and scalene muscle for 3-4 minutes each. Following this the percussive Theragun applicator will applied with circular strokes along the length of the muscle for 3 minutes. The pressure of application will adjust to the subject's tolerance.

Intervention Type OTHER

COMPRESSION THERAPY

In Group B, Compression therapy will be administered to the patients by migraine relief gel cap for 25 minutes during migraine attacks. The cap will store in a freezer (15-18°C). At the onset of the migraine attacks, patients wore the cap and used it. We will choose 25 minutes as the time for application of the gel cap based on the results of two published studies.(23) Headache severity will measured by Visual Analogue Scale and pain relief will measured on a similar scale. Analgesic treatment will not take within 25 minutes after the onset of cold therapy. If patients did not experience adequate relief from the headache, we will allow them to use analgesics 25 minutes after the onset of cold therapy. The routine physical treatment will be same as in group A.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hira jabeen

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Hira Jabeen

Role: CONTACT

0323-4116506

Rabia Amjad, DPT

Role: CONTACT

0322-7833519

Facility Contacts

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Hira Jabeen

Role: primary

0323-4116506

References

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Kelly DP, Strauss AW. Inherited cardiomyopathies. N Engl J Med. 1994 Mar 31;330(13):913-9. doi: 10.1056/NEJM199403313301308. No abstract available.

Reference Type BACKGROUND
PMID: 8114864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35027572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31870279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29535237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32507151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31580695 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/02100

Identifier Type: -

Identifier Source: org_study_id

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