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
The date of last modification
Dec 09, 2024
Trial Status
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
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
2024-03-15
Date of study completion
2024-08-30
Recruitment status
Complete: follow up continuing
Funding source
None
Regulatory approvals
Not applicable
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 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
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
2024-08-30
Final sample size
28
Date of first publication
Link to results
Brief summary of results