NCT05496010

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

August 8, 2022

Last Update Submit

January 24, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    Baseline

  • 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.

    After 2 weeks

  • 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.

    Pre-Treatment

  • 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.

    After 2 weeks. (Follow up)

  • 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.

    Pre-Treatment

  • 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.

    After 2 weeks. (Follow up)

Study Arms (2)

Dry Needling

EXPERIMENTAL

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.

Other: Dry Needling and Ischemic Compression Technique

Ischemic Compression Technique

ACTIVE COMPARATOR

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.

Other: Dry Needling and Ischemic Compression Technique

Interventions

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.

Dry NeedlingIschemic Compression Technique

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged individuals years
  • Trigger point related Tension Type Headache diagnosed by Neurologist.
  • Patients having trigger points in the muscles taken in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziauddin University

Karachi, Sindh, 75000, Pakistan

Location

Related Publications (13)

  • 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.

    PMID: 30496104BACKGROUND
  • 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.

    PMID: 28229320BACKGROUND
  • 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.

    PMID: 22364330BACKGROUND
  • 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.

    PMID: 28295304BACKGROUND
  • 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.

    PMID: 27733282BACKGROUND
  • 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.

    PMID: 30691768BACKGROUND
  • 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.

    PMID: 31572570BACKGROUND
  • 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.

    PMID: 32133042BACKGROUND
  • 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.

    PMID: 25329141BACKGROUND
  • 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.

    PMID: 30813155BACKGROUND
  • 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.

    PMID: 30615622BACKGROUND
  • 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.

    PMID: 28070269BACKGROUND
  • 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.

    PMID: 29673262BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ziauddin University

    Ziauddin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPhil Candidate ZCRS

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

March 2, 2022

Primary Completion

August 3, 2022

Study Completion

August 12, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations