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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • ripah international university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Dry Needling
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 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.
Other: Placebo Dry Needling
Placebo Dry Needling only causes a pricking sensation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
12th Week
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.
12th Week
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
12th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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