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Tension-Type HeadacheNCT05496010

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

A study testing Dry Needling and Ischemic Compression Technique in people with Tension-Type Headache, run by Ziauddin University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Tension-Type Headache
What is being tested?
Dry Needling and Ischemic Compression Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
2 Mar 2022to 12 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Medical Red flags
  • Major Depression
  • Neurological or Cardiovascular Disease.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Ziauddin University

    Karachi, Sindh, 75000

Other trials in Pakistan

About this study

Official title: 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

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.

Read the 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.

Being tested
Dry Needling and Ischemic Compression Technique
Medical subject headings
Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry Needling and Ischemic Compression TechniqueOther

    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.

Study groups in NCT05496010
Study groupRoleWhat they receive
Dry NeedlingExperimentalDry 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.
Receives: Other: Dry Needling and Ischemic Compression Technique
Ischemic Compression TechniqueActive comparatorIschemic 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.
Receives: Other: Dry Needling and Ischemic Compression Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale to assess headache intensity

    Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals, where high values indicate greater pain intensity.

    Measured: Baseline

  2. Numeric Pain Rating Scale to assess headache intensity

    Pain will be assessed through Numeric Pain Rating Scale NPRS among trigger point tension type headache individuals where high values indicate greater pain intensity.

    Measured: After 2 weeks

  3. Short Form-36 Questionnaire to measure Health related quality of life.

    All the domains of Health related quality of life assessment will be carried out through the individual's scoring.

    Measured: Pre-Treatment

  4. Short Form-36 Questionnaire to measure Health related quality of life

    All the domains of Health related quality of life assessment will be carried out through the individual's scoring.

    Measured: After 2 weeks. (Follow up)

  5. Diagnostic Ultrasound to measure muscle thickness

    An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.

    Measured: Pre-Treatment

  6. Diagnostic Ultrasound to measure muscle thickness

    An ultrasound examination will be performed to find out the muscle thickness of cervical muscles in which trigger points are present.

    Measured: After 2 weeks. (Follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start2 Mar 2022
  3. Primary completion3 Aug 2022
  4. Study completion12 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496010
Sponsor's protocol ID
4541121AAREH
Status last verified
Jan 2023
First submitted
8 Aug 2022
Last updated
25 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30496104
  • 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.

    PubMed 28229320
  • 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.

    PubMed 22364330
  • 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.

    PubMed 28295304
  • 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.

    PubMed 27733282
  • 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.

    PubMed 30691768
  • 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.

    PubMed 31572570
  • 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.

    PubMed 32133042
  • 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.

    PubMed 25329141
  • 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.

    PubMed 30813155
  • 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.

    PubMed 30615622
  • 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.

    PubMed 28070269
  • 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.

    PubMed 29673262

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling and Ischemic Compression Technique in people with Tension-Type Headache, run by Ziauddin University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale to assess headache intensity (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496010, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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