Home » Trials » SLCTR/2024/009


Effectiveness of Dry Needling for Improving Pain and Disability in Adults with Migraine Headache; A Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2024/009


Date of Registration

15 Mar 2024

The date of last modification

Mar 15, 2024



Application Summary


Scientific Title of Trial

Effectiveness of Dry Needling for Improving Pain and Disability in Adults with Migraine Headache; A Randomized Controlled Trial


Public Title of Trial

Effectiveness of dry needling compared to placebo needling for easing pain and disability among adults with migraine headache: A Randomized Controlled Trial


Disease or Health Condition(s) Studied

Migraine Headache


Scientific Acronym

None


Public Acronym

None


Brief title

Dry Needling for Migraine Relief: A Randomized Controlled Trial


Universal Trial Number

U1111-1302-0222


Any other number(s) assigned to the trial and issuing authority

ERC/2023/73: Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka


Trial Details


What is the research question being addressed?

Is dry needling effective compared to placebo needling effect in easing pain and disability among adults with migraine headache?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Outcome assessors


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

• Study setting: Teaching Hospital, Anuradhapura. • Randomization: 1:1 randomization using sealed envelopes. • Treatment group: Dry needling for active trigger points in suboccipital, and cervical musculature will be performed by a Certified Dry Needling Physiotherapist. Treatment will be continued for 3 days per week with 48 hours gap in between. Dry Needling is defined by the American Physical Therapy Association (APTA) as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular and connective tissue for the management of neuromuscular pain and movement impairments.

• Control group: Sham needling will be performed by the same therapist where active trigger points are not identified. In sham intervention, patients will be treated with muscle pressed with tube housing of the needle, but the needle will never be inserted into the skin. Sham Needling will be done four times superficially where trigger points are not identified in the same frequency and same duration as the intervention group.

• Both groups will receive neck specific muscle strengthening program as part of standard of care. *.Headache diary: will be measured in both treatment and control groups at the baseline, 1 week after the commencement and at the end of 4 weeks. • Both patients and assessors are blinded to the treatments, and patients are unaware of whether they have received active or sham dry needling


Inclusion criteria

• Adult patients with migraine headache * Minimum age 18 and maximum age 50 years • Diagnosis should be confirmed by a consultant neurologist based on the International Classification of Headache Disorders (ICHD-3). • Patients should have at least one active trigger point in their suboccipital and cervical musculature.


Exclusion criteria

• Patient with a history of neck trauma, cervical radiculopathy • Patients with previous surgery on the neck or shoulder area • Patients with abnormal bleeding tendencies, a severely compromised immune system, vascular disease • Frail patients, • Patients with epilepsy • Patient allergic to metals or latex • Patients with altered psychological status, • Patient with prosthetic implants, and implantable electrical devices. • Patients with a history of physiotherapy intervention in the neck and shoulder region in the previous six months • Pregnancy • Patients with needle phobia • Patients who are on anticoagulant therapy • Patients with thrombocytopenia and those with lymphedema in a specific area or limb.



Primary outcome(s)

1.

Headache intensity and frequency will be measured by using visual analogue scale and headache diary.

Headache frequency of the participants will be measured by maintaining a headache diary to record the number of headaches and duration (minutes/hours) per day in a week. Headache frequency is calculated as the weekly average for each subject as a primary outcome measure during the time frame of research conducts.

[

At the baseline, 1 week after the commencement of intervention, and at the end of 4 weeks

]

Secondary outcome(s)

1.

Migraine-related disability and Quality of Life will be measured by using the Headache Impact Test (HIT) and Headache Disability Inventory questionnaires.

Migraine-related disability will be measured by using the Migraine Disability Assessment (MIDAS) questionnaire in both treatment

[

At the baseline, end of the treatment protocol after one week of DN therapy, and 4 weeks after the intervention

]

Target number/sample size

140 patients (70 for each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2024-03-15


Anticipated end date

2024-05-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2023-12-19


Approval number

ERC/2023/73


Details of Ethics Review Committee

Name: Ethics Review Committee
Institutional Address: Faculty of Medicine & Allied Sciences Rajarata University of Sri Lanka
Telephone:0252053633
Email: erc@med.rjt.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

H. M. M. D. Herath
Physiotherapist
Department of Physiotherapy, Teaching Hospital, Anuradhapura.
0252222261
0711330766

madhushiherath@gmail.com

Contact Person for Public Queries

Dr. ACM Fahim
Senior Research Fellow/Director
SACTRC, Faculty of Medicine, University of Peradeniya

07814479822

fahim.cader@gmail.com


Primary study sponsor/organization

University of Peradeniya

University of Peradeniya, Peradeniya, Sri Lanka.



Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

Yes


Protocol version and date

version 3.0 on 15th September 2023


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results