NCT05285852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

March 8, 2022

Last Update Submit

May 18, 2022

Conditions

Keywords

Dry NeedlingSternocleidomastoid MusclePainDisabilityRandomized Control TrialMigraine

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    12th Week

  • Sternocleidomastoid muscle Ultrasonography

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

    12th Week

Study Arms (2)

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.

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.

Other: Placebo Dry Needling

Interventions

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.

Dry Needling

Placebo Dry Needling only causes a pricking sensation

Placebo Dry Needling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • background of neck trauma
  • cervical radiculopathy
  • History of head/shoulder surgery
  • Diagnosis of other unusual headaches/migraines
  • Phobia of pricking
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Migraine DisordersPain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 18, 2022

Study Start

March 1, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations