Comparing the Effectiveness of Dry Needling and Ischemic Compression on Tension Type Headache

NCT ID: NCT05496010

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2022-08-12

Brief Summary

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Headaches are the main health problem as one of the prevalent type of all symptoms in the world population. Among different types of headaches, the most prevailing primary headache in general population is Tension-type headache (TTH). According to Global Burden Disease study conducted in 2016 tension-type headache ranks the third highest primary headache syndromes among 32 diseases and injuries in 195 countries from the Period of 1990 to 2016.These types of headaches are associated with significant reductions in productivity of an individual with prominent increase in socioeconomic costs. There are various treatments suggested for improving the symptoms in trigger point related tension type headaches such as usage of hot packs, cryotherapy, ultrasound therapy, mobilization and manipulation techniques, Dry needling, MET and ICT. None of the study has been conducted in Pakistan which has compared two specific techniques to resolve trigger points with the accuracy of diagnosis by diagnostic ultrasound in limited time period, which is cost friendly, and provides quick relief to patients without causing a lot of pain. Therefore, more studies are needed to overcome the gap area in the use of specific techniques in clinics with accurate diagnosis by the clinicians of Pakistan.

Detailed Description

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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.

Conditions

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A: Dry Needling treatment given for 6 sessions, 3 days/week for 2 weeks on the trigger points located in Upper Trapezius, Sternocleidomastoid, Sub occipitalis and Temporalis muscles.

Group B:

Ischemic Compression technique given for 6 sessions, 3 days/week for 2 weeks on the trigger points located in Upper Trapezius, Sternocleidomastoid, Sub occipitalis and Temporalis muscles.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
All participants will be blinded regarding treatment. A total of 30 patients will be recruited and assigned into two groups. Group A will receive Dry needling sessions and group B will receive Ischemic compression technique.

Study Groups

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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.

Group Type EXPERIMENTAL

Dry Needling and Ischemic Compression Technique

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Dry Needling and Ischemic Compression Technique

Intervention Type OTHER

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.

Interventions

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Dry Needling and Ischemic Compression Technique

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziauddin University

OTHER

Sponsor Role lead

Responsible Party

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Aribah Ahmed

MPhil Candidate ZCRS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziauddin University

Role: PRINCIPAL_INVESTIGATOR

Ziauddin

Locations

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Ziauddin University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30496104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28229320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22364330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28295304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27733282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30691768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31572570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32133042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25329141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30813155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30615622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28070269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29673262 (View on PubMed)

Other Identifiers

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4541121AAREH

Identifier Type: -

Identifier Source: org_study_id

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