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NCT Number: NCT06504537

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

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Hira Jabeen

CONTACT

[email protected]

0323-4116506

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Congenital Condition of cervical spine
  • Inability of neck to perform flexion-rotation test
  • Meningitis, deep vein thrombosis
  • other-type of headache
  • Headache attributed to trauma or injury to neck

Treatment and study plan

THERAGUN PERCUSSION THERAPY

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.

Compression Therapy

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.

Primary outcomes

  1. International Classification of Headache Disorders (ICHD-3)

    Time frame: 6 weeks

    Using ICHD-3 can aid first-visit patients by providing extended likely categories and removing the requirement for underlying cause disease remission before headache diagnosis. One of the ICHD-3 criteria for diagnosing migraines is

    • the quality of the pulsating pain.
    • Moderate to severe levels of pain
    • Made worse by day-to-day ordinary activities

Secondary outcomes

  1. Neck Disability Index (NDI)

    Time frame: 6 weeks

    The Neck Impairment Index is the most commonly used questionnaire to evaluate neck pain impairment (NDI) The NDI consists of ten questions: two ask about symptoms, the remaining question concerns concentration, and the other seven center on functional tasks. The 20-item test looks at four areas: activities of daily living, pain severity, emotion/cognition, and neck function. These categories show how a patient's neck pain condition affects their ability to operate both physically and emotionally

  2. Migraine Screening Quality of Life Questionnaire (MS-Q)

    Time frame: 6 weeks

    The five-item migraine screen questionnaire, or MS-Q, was developed for use in research and clinical settings including occupational medicine and the general public as well as occupational medicine practitioners. The questionnaire is based on the diagnostic criteria for migraines published by the International Headache Society (IHS). This structured questionnaire consists of five items, each with a yes/no binary response option.

    For every "NO" response, a score of 0 is given, and for every "YES" response, a score of

    • A cut-off point of ≥4 indicates a migraine case and a total score of 5 indicates this.

  3. Visual Analogue Scale (VAS)

    Time frame: 6 weeks

    The VAS for attention was used to measure the participants' self-reported level of difficulty in maintaining focus. The participants were instructed to write a mark on the line that most accurately expressed their feelings regarding the challenge of paying attention.rating fron 0 to 10. 0 for no pain and 10 for worst pain.

Other outcomes

  1. Bubble Inclinometer

    Time frame: 6 weeks

    Range of-motion is measured with a Bubble Inclinometer. Position the inclinometer near the joint that has to be measured; rotate the dial until the scale reaches zero; proceed to move the joint over its range; and finally, determine the distance traveled directly from the dial.

Study contacts

Contact information is provided by the study sponsor or research team.

Hira Jabeen

CONTACT

[email protected]

0323-4116506

Rabia Amjad, DPT

CONTACT

[email protected]

0322-7833519

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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