- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496010
Comparing the Effectiveness of Dry Needling and Ischemic Compression on Tension Type Headache
Comparing the Effectiveness of Dry Needling and Ischemic Compression Technique on Muscle Thickness and Health Related Quality of Life in Trigger Point Tension Type Headache
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research aims to compare the effectiveness of Dry Needling and Ischemic Compression Technique on muscle thickness & health related quality of life in trigger point related tension type headache. Headaches are the major health concern as one of the prevalent type of all symptoms in the worldwide population and are the cause of disabilities and hindrance in productivity of an individual.
The treatment approaches performed for trigger point related tension type headache are non-specific, vigorous, time consuming and costly. It is due to the inaccurate location of the trigger points present in cervical musculature. The studies related to comparison of specific treatment procedures to treat trigger point related tension type headaches such as dry needling and Ischemic Compression technique with the knowledge of accurate location of trigger points present in cervical musculature are lacking in Pakistani population. Hence the current study is aimed to determine the effect of dry needling and Ischemic Compression technique with the use of diagnostic ultrasound on muscle thickness, pain and health related quality of life in Trigger point related tension type headache. The study will be conducted on the tension type headache diagnosed individuals aged 20 to 50 years of age, at Physical Therapy OPD of Saifee and Ziauddin Hospital with the help of envelope method as a randomization technique. Dry needling will be performed on Group A whereas Group B will be given Ischemic Compression technique on trigger points diagnosed by Musculoskeletal Ultrasound. Patient's headache, muscle thickness and health related quality of life will be assessed by Numeric Pain rating scale, Musculoskeletal Ultrasound and Short Form-36 Questionnaire respectively. If the data will be found to be normally distributed, Pair T-test will be run for with the group analysis. Between the groups an alysis will be perform by Independent t test. In case data found to be deviated from the assumption of normal distribution, Paired T-test will be replaced by Wilcoxon test and Independent T test will be replaced by Mann Whitney U Test. The level of significance will be kept at 95% alpha-0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 75000
- Ziauddin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20-50 aged individuals years
- Trigger point related Tension Type Headache diagnosed by Neurologist.
- Patients having trigger points in the muscles taken in the study.
Exclusion Criteria:
- Medical Red flags
- Major Depression
- Neurological or Cardiovascular Disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling
Dry needling will be performed on the patients of group A after the diagnosis of trigger points in particular muscles.The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.
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For Group A, Dry needling will be applied into trigger points which are active and present in the muscles, efficiently and within the safe limits taking all the safety precautions. For group B, Ischemic Compression Technique will be applied on trigger points. The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved for both the groups. |
|
Active Comparator: Ischemic Compression Technique
Ischemic Compression technique will be performed on the patients of group B after the diagnosis of trigger points in particular muscles by diagnostic ultrasound.
The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved.
|
For Group A, Dry needling will be applied into trigger points which are active and present in the muscles, efficiently and within the safe limits taking all the safety precautions. For group B, Ischemic Compression Technique will be applied on trigger points. The complete treatment session will be comprised of 3 sessions per week for two weeks followed by follow up after 1 month until the symptoms have been improved for both the groups. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale to assess headache intensity
Time Frame: Baseline
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Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals, where high values indicate greater pain intensity.
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Baseline
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Numeric Pain Rating Scale to assess headache intensity
Time Frame: After 2 weeks
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Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals where high values indicate greater pain intensity.
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After 2 weeks
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Short Form-36 Questionnaire to measure Health related quality of life.
Time Frame: Pre-Treatment
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All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
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Pre-Treatment
|
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Short Form-36 Questionnaire to measure Health related quality of life
Time Frame: After 2 weeks. (Follow up)
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All the domains of Health related quality of life assessment will be carried out through the individual's scoring.
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After 2 weeks. (Follow up)
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Diagnostic Ultrasound to measure muscle thickness
Time Frame: Pre-Treatment
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An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.
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Pre-Treatment
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Diagnostic Ultrasound to measure muscle thickness
Time Frame: After 2 weeks. (Follow up)
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An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.
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After 2 weeks. (Follow up)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ziauddin University, Ziauddin
Publications and helpful links
General Publications
- GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum In: Lancet. 2017 Jan 7;389(10064):e1.
- Gildir S, Tuzun EH, Eroglu G, Eker L. A randomized trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine (Baltimore). 2019 Feb;98(8):e14520. doi: 10.1097/MD.0000000000014520.
- Moraska AF, Stenerson L, Butryn N, Krutsch JP, Schmiege SJ, Mann JD. Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial. Clin J Pain. 2015 Feb;31(2):159-68. doi: 10.1097/AJP.0000000000000091.
- GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
- Kamali F, Mohamadi M, Fakheri L, Mohammadnejad F. Dry needling versus friction massage to treat tension type headache: A randomized clinical trial. J Bodyw Mov Ther. 2019 Jan;23(1):89-93. doi: 10.1016/j.jbmt.2018.01.009. Epub 2018 Jan 31.
- Herekar AA, Ahmad A, Uqaili UL, Ahmed B, Effendi J, Alvi SZ, Shahab MA, Javed U, Herekar AD, Khanani R, Steiner TJ. Primary headache disorders in the adult general population of Pakistan - a cross sectional nationwide prevalence survey. J Headache Pain. 2017 Dec;18(1):28. doi: 10.1186/s10194-017-0734-1. Epub 2017 Feb 23.
- Alonso-Blanco C, de-la-Llave-Rincon AI, Fernandez-de-las-Penas C. Muscle trigger point therapy in tension-type headache. Expert Rev Neurother. 2012 Mar;12(3):315-22. doi: 10.1586/ern.11.138.
- Jensen RH. Tension-Type Headache - The Normal and Most Prevalent Headache. Headache. 2018 Feb;58(2):339-345. doi: 10.1111/head.13067. Epub 2017 Mar 13.
- Pourahmadi M, Mohseni-Bandpei MA, Keshtkar A, Koes BW, Fernandez-de-Las-Penas C, Dommerholt J, Bahramian M. Effectiveness of dry needling for improving pain and disability in adults with tension-type, cervicogenic, or migraine headaches: protocol for a systematic review. Chiropr Man Therap. 2019 Sep 26;27:43. doi: 10.1186/s12998-019-0266-7. eCollection 2019.
- Shields G, Smith JM. Remedial Massage Therapy Interventions Including and Excluding Sternocleidomastoid, Scalene, Temporalis, and Masseter Muscles for Chronic Tension Type Headaches: a Case Series. Int J Ther Massage Bodywork. 2020 Feb 26;13(1):22-31. eCollection 2020 Mar.
- Munoz-Ceron J, Marin-Careaga V, Pena L, Mutis J, Ortiz G. Headache at the emergency room: Etiologies, diagnostic usefulness of the ICHD 3 criteria, red and green flags. PLoS One. 2019 Jan 7;14(1):e0208728. doi: 10.1371/journal.pone.0208728. eCollection 2019.
- Overas CK, Myhrvold BL, Rosok G, Magnesen E. Musculoskeletal diagnostic ultrasound imaging for thickness measurement of four principal muscles of the cervical spine -a reliability and agreement study. Chiropr Man Therap. 2017 Jan 4;25:2. doi: 10.1186/s12998-016-0132-9. eCollection 2017.
- Young IA, Dunning J, Butts R, Cleland JA, Fernandez-de-Las-Penas C. Psychometric properties of the Numeric Pain Rating Scale and Neck Disability Index in patients with cervicogenic headache. Cephalalgia. 2019 Jan;39(1):44-51. doi: 10.1177/0333102418772584. Epub 2018 Apr 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4541121AAREH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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