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Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry Needling
Placebo Dry Needling
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Dry Needling, Sternocleidomastoid Muscle, Pain, Disability, Randomized Control Trial, Migraine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dry Needling

Placebo Dry Needling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Sternocleidomastoid muscle Ultrasonography
An ultrasonograph scan uses high-frequency sound waves to make an image of a person's internal body structures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
May 18, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05285852
Brief Title
Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine
Official Title
The Effects of Triggering Points Dry Needling on Sternocleidomastoid Muscle for Pain and Disability in Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Dry Needling, Sternocleidomastoid Muscle, Pain, Disability, Randomized Control Trial, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Dry Needling
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Dry Needling
Intervention Description
Placebo Dry Needling only causes a pricking sensation
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
12th Week
Title
Bubble Inclinometer
Description
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.
Time Frame
12th Week
Title
Sternocleidomastoid muscle Ultrasonography
Description
An ultrasonograph scan uses high-frequency sound waves to make an image of a person's internal body structures
Time Frame
12th Week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine

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