NCT06504537

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

July 15, 2024

Conditions

Migraine

Keywords

neck stiffnessheadachePNFstrtechingcompression therapy

Outcome Measures

Primary Outcomes (1)

  • International Classification of Headache Disorders (ICHD-3)

    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

    6 weeks

Secondary Outcomes (3)

  • Neck Disability Index (NDI)

    6 weeks

  • Migraine Screening Quality of Life Questionnaire (MS-Q)

    6 weeks

  • Visual Analogue Scale (VAS)

    6 weeks

Other Outcomes (1)

  • Bubble Inclinometer

    6 weeks

Study Arms (2)

GROUP A: THERAGUN PERCUSSION THERAPY AND ROUTINE PHYSICAL THERAPY

EXPERIMENTAL

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

Other: THERAGUN PERCUSSION THERAPY

GROUP B: COMPRESSION THERAPY AND ROUTINE PHYSICAL THERAPY

EXPERIMENTAL

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.

Other: COMPRESSION THERAPY

Interventions

THERAGUN PERCUSSION THERAPYOTHER

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 A: THERAGUN PERCUSSION THERAPY AND ROUTINE PHYSICAL THERAPY
COMPRESSION THERAPYOTHER

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.

GROUP B: COMPRESSION THERAPY AND ROUTINE PHYSICAL THERAPY

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both Genders
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (6)

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

    PMID: 8114864BACKGROUND

  • 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.

    PMID: 35027572BACKGROUND

  • 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.

    PMID: 31870279BACKGROUND

  • 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.

    PMID: 29535237BACKGROUND

  • 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.

    PMID: 32507151BACKGROUND

  • 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.

    PMID: 31580695BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hira jabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Jabeen

CONTACT

0323-4116506hira.jabeen@riphah.edu.pk

Rabia Amjad, DPT

CONTACT

0322-7833519rabiamughal614@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the study would be single blinded as the assessor of the study would be kept blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

July 16, 2024

Study Start

January 1, 2024

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)