MigraineNCT05285852
Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine
A study testing Dry Needling in people with Migraine, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 15 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- background of neck trauma
- cervical radiculopathy
- History of head/shoulder surgery
- Diagnosis of other unusual headaches/migraines
- Phobia of pricking
- pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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
- Conditions
- Migraine
- Being tested
- Dry Needling, Placebo Dry Needling
- Keywords
- Dry Needling, Sternocleidomastoid Muscle, Pain, Disability, Randomized Control Trial, Migraine
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
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.
Placebo Dry NeedlingOther
Placebo Dry Needling only causes a pricking sensation
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | 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. Receives: Other: Dry Needling |
| Placebo Dry Needling | Placebo comparator | 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. Receives: Other: Placebo Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
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.
Measured: 12th Week
Bubble Inclinometer
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.
Measured: 12th Week
Sternocleidomastoid muscle Ultrasonography
An ultrasonograph scan uses high-frequency sound waves to make an image of a person's internal body structures
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Mar 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285852
- Sponsor's protocol ID
- REC-FSD-00258
- Status last verified
- May 2022
- First submitted
- 8 Mar 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Triggering Points Dry Needling on Sternocleidomastoid Muscle for Pain and Disability in Migraine
- ClinicalTrials.gov ID
- NCT05285852
- Acronym / sponsor ID
- REC-FSD-00258
- Conditions
- Migraine
- Keywords
- Dry Needling, Sternocleidomastoid Muscle, Pain, Disability, Randomized Control Trial, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 18 Mar 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Other: Dry NeedlingFor 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. |
| Placebo Dry Needling | Placebo comparator | Other: Placebo Dry NeedlingFollowing 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- background of neck trauma
- cervical radiculopathy
- History of head/shoulder surgery
- Diagnosis of other unusual headaches/migraines
- Phobia of pricking
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 |
|---|---|---|
| Dry NeedlingDry 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. | Other | Dry Needling |
| Placebo Dry NeedlingPlacebo Dry Needling only causes a pricking sensation | Other | Placebo Dry Needling |
Primary outcome
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.
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.
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
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 19 May 2022.
- 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.
Muhammad Kashif study chair
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 Dry Needling 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 4 inclusion and 6 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 19 May 2022. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: 12th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.