Migraine DisordersNCT06197542
Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine
A study testing Active Release Technique and Instrument Assisted Soft Tissue Mobilization in people with Migraine Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
Rationale of this research is to evaluate the outcome of active release technique and Instrument assisted soft tissue mobilization on trigger points in subjects with Migraine. The significance of this study is to identify which technique is superior in alleviating the symptoms of migraine. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Active Release Technique and Instrument Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2023to 15 Nov 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female 18-30 years Trigger points in Trapezius , Sternocleidomastoid and Sub-occipitals (Identified using Travel and Simmons Criteria) Migraine without Aura Subjects were cognitively capable and competent to follow the instructions
Who cannot join
- Dysfunctions in the temporomandibular joint. Participant with a history of basilar migraine or hemiplegic migraine Fracture of Cervical Spine Currently on Medication for Migraine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gulberg green campus of Riphah International University
Islamabad, Punjab Province, 44000
About this study
Rationale of this research is to evaluate the outcome of active release technique and Instrument assisted soft tissue mobilization on trigger points in subjects with Migraine. The significance of this study is to identify which technique is superior in alleviating the symptoms of migraine. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of Migraine.
Read the detailed description
Migraine is a neurological condition that typically causes painful headache attacks lasting from four to 72 hours that occur with additional symptoms, such as sensitivity to light, sound, smell, or touch. Migraines occur most frequently in the morning, especially upon waking. Migraines can be triggered by stress or hormones. Migraine attacks are debilitating and can hinder the day to day activities and productivity of the patient. The purpose of the study was to evaluate the effects of active release technique and instrument assisted soft tissue mobilization on trigger points. It was a randomized, controlled trial, conducted among migraine patients. Sample size was 54 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope.All participants in both groups were evaluated on baseline and post-intervention.
- Conditions
- Migraine Disorders
- Being tested
- Active Release Technique, Instrument Assisted Soft Tissue Mobilization
- Keywords
- Trigger points,, Active release Technique,, IATSM
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Release TechniqueOther
active TrP was identified, and sustained and constant pressure was applied .for stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck.
Instrument Assisted Soft Tissue MobilizationOther
The therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin. .
| Study group | Role | What they receive |
|---|---|---|
| Active Release Technique | Experimental | Individuals in Group A will be subjected to Heat Therapy over the targeted muscles via hot pack for 5 minutes in every session along with passive stretching for 5 minutes Group A will receive Active release technique on targeted muscles. The participant was comfortably seated and rested the forehead on the forearms .To apply for the release, the active TrP was identified, and sustained and constant pressure was applied. For stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck.The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week. Receives: Other: Active Release Technique |
| Instrument Assisted Soft Tissue Mobilization | Experimental | Group A will be subjected to Heat Therapy for 5minutes along with Stretching for 5 minutes .Group B will be Subjected to IASTM using M2T blade for approximately 3 minutes per muscle. Lubricant was applied and the tool was cleaned with an alcohol pad.the tool was used to locate soft tissue restrictions in the muscles. Then, the therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin Treatment time was 3 minutes. Cryotherapy was applied for 10 minutes after the session. The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rate Scale:
Numeric Pain Rate Scale used to measure pain intensity.
Measured: 3rd week
Cervical Goniometer
Cervical Goniometer used to assess cervical ranges.
Measured: 3rd week
Secondary outcomes (1)
HIT-6 Headache Impact Test
The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start10 Apr 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies 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
- Model description
- Participants were randomly assigned to the A group or B group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled \"Group A\" or \"Group B.\" Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197542
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/015
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482.
PubMed 25600719Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
PubMed 35281991Garcia-Leiva JM, Hidalgo J, Rico-Villademoros F, Moreno V, Calandre EP. Effectiveness of ropivacaine trigger points inactivation in the prophylactic management of patients with severe migraine. Pain Med. 2007 Jan-Feb;8(1):65-70. doi: 10.1111/j.1526-4637.2007.00251.x.
PubMed 17244105
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Release Technique and Instrument Assisted Soft Tissue Mobilization in Patients With Migraine
- ClinicalTrials.gov ID
- NCT06197542
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/015
- Conditions
- Migraine Disorders
- Keywords
- Trigger points,, Active release Technique,, IATSM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 9 Jan 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.
Rationale of this research is to evaluate the outcome of active release technique and Instrument assisted soft tissue mobilization on trigger points in subjects with Migraine. The significance of this study is to identify which technique is superior in alleviating the symptoms of migraine. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of Migraine.
Detailed description
Migraine is a neurological condition that typically causes painful headache attacks lasting from four to 72 hours that occur with additional symptoms, such as sensitivity to light, sound, smell, or touch. Migraines occur most frequently in the morning, especially upon waking. Migraines can be triggered by stress or hormones. Migraine attacks are debilitating and can hinder the day to day activities and productivity of the patient. The purpose of the study was to evaluate the effects of active release technique and instrument assisted soft tissue mobilization on trigger points. It was a randomized, controlled trial, conducted among migraine patients. Sample size was 54 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope.All participants in both groups were evaluated on baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the A group or B group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled \"Group A\" or \"Group B.\" Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.
| Arm | Type | Receives |
|---|---|---|
| Active Release Technique | Experimental | Other: Active Release TechniqueIndividuals in Group A will be subjected to Heat Therapy over the targeted muscles via hot pack for 5 minutes in every session along with passive stretching for 5 minutes Group A will receive Active release technique on targeted muscles. The participant was comfortably seated and rested the forehead on the forearms .To apply for the release, the active TrP was identified, and sustained and constant pressure was applied. For stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck.The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week. |
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationGroup A will be subjected to Heat Therapy for 5minutes along with Stretching for 5 minutes .Group B will be Subjected to IASTM using M2T blade for approximately 3 minutes per muscle. Lubricant was applied and the tool was cleaned with an alcohol pad.the tool was used to locate soft tissue restrictions in the muscles. Then, the therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin Treatment time was 3 minutes. Cryotherapy was applied for 10 minutes after the session. The treatment regimen will span over 3 weeks with a follow up frequency of 2 sessions per week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both male and female 18-30 years Trigger points in Trapezius , Sternocleidomastoid and Sub-occipitals (Identified using Travel and Simmons Criteria) Migraine without Aura Subjects were cognitively capable and competent to follow the instructions
Key exclusion criteria (1 listed)
- Dysfunctions in the temporomandibular joint. Participant with a history of basilar migraine or hemiplegic migraine Fracture of Cervical Spine Currently on Medication for Migraine
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 |
|---|---|---|
| Active Release Techniqueactive TrP was identified, and sustained and constant pressure was applied .for stretching of the SCM muscle, the patient performed contralateral lateral flexion and ipsilateral rotation of the head to achieve stretching, for trapezius the therapist performed lateral flexion of the neck. | Other | Active Release Technique |
| Instrument Assisted Soft Tissue MobilizationThe therapist applied IASTM strokes for 20 seconds parallel to muscle fibers, followed by strokes for 20 seconds perpendicular to muscle fibers with the tool held at a 45° to the skin. . | Other | Instrument Assisted Soft Tissue Mobilization |
Primary outcome
Numeric Pain Rate Scale:
Time frame: 3rd week
Numeric Pain Rate Scale used to measure pain intensity.
Cervical Goniometer
Time frame: 3rd week
Cervical Goniometer used to assess cervical ranges.
1 secondary outcome
HIT-6 Headache Impact Test
Time frame: 3rd week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 25600719Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482.
- Background: PubMed 35281991Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
- Background: PubMed 17244105Garcia-Leiva JM, Hidalgo J, Rico-Villademoros F, Moreno V, Calandre EP. Effectiveness of ropivacaine trigger points inactivation in the prophylactic management of patients with severe migraine. Pain Med. 2007 Jan-Feb;8(1):65-70. doi: 10.1111/j.1526-4637.2007.00251.x.
- 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.
Ramsha Tariq, MS-OMPT 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 Active Release Technique and Instrument Assisted Soft Tissue Mobilization in people with Migraine Disorders, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rate Scale: (time frame: 3rd week). The study lists 2 primary outcomes in all. 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 NCT06197542, which also lists 3 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 9 Jan 2024.