MigraineNCT06504537
Comparative Effects of Theragun Percussion Therapy and Compression Therapy in The Patients With Migraine
A study testing THERAGUN PERCUSSION THERAPY and COMPRESSION THERAPY in people with Migraine, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- THERAGUN PERCUSSION THERAPY and COMPRESSION THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Hira Jabeen, 0323-4116506, hira.jabeen@riphah.edu.pk
About this study
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
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
Read the 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.
- Conditions
- Migraine
- Being tested
- THERAGUN PERCUSSION THERAPY, COMPRESSION THERAPY
- Keywords
- neck stiffness, headache, PNF, strteching, compression therapy
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: COMPRESSION THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
Neck Disability Index (NDI)
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
Measured: 6 weeks
Migraine Screening Quality of Life Questionnaire (MS-Q)
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.
Measured: 6 weeks
Visual Analogue Scale (VAS)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hira jabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504537
- Sponsor's protocol ID
- REC/RCR&AHS/23/02100
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly DP, Strauss AW. Inherited cardiomyopathies. N Engl J Med. 1994 Mar 31;330(13):913-9. doi: 10.1056/NEJM199403313301308. No abstract available.
PubMed 8114864Ferrari 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.
PubMed 35027572Andreou 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.
PubMed 31870279Allen 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.
PubMed 29535237Wanderley 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.
PubMed 32507151Nasb 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.
PubMed 31580695
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06504537
- Acronym / sponsor ID
- REC/RCR&AHS/23/02100
- Conditions
- Migraine
- Keywords
- neck stiffness, headache, PNF, strteching, compression therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A: THERAGUN PERCUSSION THERAPY AND ROUTINE PHYSICAL THERAPY | Experimental | Other: THERAGUN PERCUSSION THERAPYPatients will receive Theragun Percussion Therapy for 25 minutes along with Routine Physical Therapy Treatment for 20 minutes |
| GROUP B: COMPRESSION THERAPY AND ROUTINE PHYSICAL THERAPY | Experimental | Other: COMPRESSION THERAPYCompression 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERAGUN PERCUSSION THERAPYIn 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. | Other | GROUP A: THERAGUN PERCUSSION THERAPY AND ROUTINE PHYSICAL THERAPY |
| COMPRESSION THERAPYIn 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. | Other | GROUP B: COMPRESSION THERAPY AND ROUTINE PHYSICAL THERAPY |
Primary outcome
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
3 secondary outcomes
Neck Disability Index (NDI)
Time frame: 6 weeks
Migraine Screening Quality of Life Questionnaire (MS-Q)
Time frame: 6 weeks
Visual Analogue Scale (VAS)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 8114864Kelly DP, Strauss AW. Inherited cardiomyopathies. N Engl J Med. 1994 Mar 31;330(13):913-9. doi: 10.1056/NEJM199403313301308. No abstract available.
- Background: PubMed 35027572Ferrari 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.
- Background: PubMed 31870279Andreou 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.
- Background: PubMed 29535237Allen 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.
- Background: PubMed 32507151Wanderley 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.
- Background: PubMed 31580695Nasb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hira jabeen principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERAGUN PERCUSSION THERAPY and COMPRESSION THERAPY in people with Migraine, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen (0323-4116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Classification of Headache Disorders (ICHD-3) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504537, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.