- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05285852
Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine
May 18, 2022 updated by: Riphah International University
The Effects of Triggering Points Dry Needling on Sternocleidomastoid Muscle for Pain and Disability in Migraine
To determine the effects, sequel of dry needling in migraine by resolving MTrPs in sternocleidomastoid muscle.
To determine the possession of dry needling technique to mitigate the frequency, intensity and duration of headache.
To determine the effectiveness of dry needling in the disability hindrance in migraine patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized control study of 60 volunteers with migraine induced by myofacial triggers in sternocleidomastoid muscle.
The migraine will be diagnosed by the neurologist and for the evaluation of trigger points and muscle thickness ultrasound will be done.
After the diagnostic procedure and complete history evaluation from the selected population 30 subjects will be subjected to dry needling group and 30 others will be kept in the placebo group.
All the participants will receive six sessions at the myofascial trigger point area there should be the gap of at least 48 hours between two sessions.
As for the assessment details, such as the frequency, intensity and duration of the headaches; the consumption of drugs; the thickness of SCM muscles; the pain pressure threshold and the cervical range motions will be recorded before, immediately following the response, and at the 1-month follow-up
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Submitted with a headache diagnosis by a neurologist.
- Presence of active Trigger points in the Sternocleidomastoid muscle reproducing the symptoms of migraine.
- Active trigger points will be identified if "there is muscle sensitivity that has been activated by pressure and reproduces the patient's referred pain and headache."
- A jump sign the characteristic behavioral response to compression on a trigger point, will be produced.
Exclusion Criteria:
- background of neck trauma
- cervical radiculopathy
- History of head/shoulder surgery
- Diagnosis of other unusual headaches/migraines
- Phobia of pricking
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling
For application of the Dry Needling the individual should be in the supine position.
To facilitate the approach and adhesion of the Sternocleidomastoid Muscle, the person's neck is placed ipsilaterally in the slightly lateral flexed position.
Consequently, the therapist identified the active Trigger Points in the Sternocleidomastoid Muscle and cleansed the surface using an antiseptic solution.
Using the insertion pipe, the dry needle inserted into the muscle.
For the separation of neurovascular structure from muscle belly the needle is carried out in an anterior-posterior direction.
A compression of 90 secs with a cotton swab will be applied at the needling site immediately after removing the needle to reduce the intensity and duration of pain.
The variables will then be measured immediately following the processing session.
Six sessions of Dry Needling will be applied to each patient and there will be a gap of at least 48 hours between each session.
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Dry needling technique is maneuvered by different skilled health practitioners aiming to reduce central sensitization, i.e., the hypersensitivity to pain of the central nervous system.
It is also apprehended to reduce the local and referred pain, and improve the muscle activation patterns leading to improved range of motion.
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Placebo Comparator: Placebo Dry Needling
Following identification of the trigger point in the muscle, the surface would be cleaned with an antiseptic solution.
For placebo Dry Needling, which only causes a pricking sensation, a blunt needle will be applied to the trigger points without penetrating the skin after application of a certain pressure to the skin.
The protocol will be applied six times, with a two-day pause between treatments.
Like the intervention group, the variables will be measured immediately after the processing session.
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Placebo Dry Needling only causes a pricking sensation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 12th Week
|
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
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12th Week
|
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Bubble Inclinometer
Time Frame: 12th Week
|
Bubble Inclinometer is a simple to use device for measuring range of motion in patients.
The inclinometer can be used to measure range of motion in the neck, the hip, the elbow, the knee, the shoulder, the spine, the ankle, the wrist, and the Metacarpophalangeal joint.
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12th Week
|
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Sternocleidomastoid muscle Ultrasonography
Time Frame: 12th Week
|
An ultrasonograph scan uses high-frequency sound waves to make an image of a person's internal body structures
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12th Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
May 15, 2022
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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