Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06100588

The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.

Led by University Ghent · Updated on 2024-09-19

152

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project comprises two studies; a cross-sectional study and a randomized controlled trial. 1. The goal of the cross-sectional study is to compare multiple outcome parameters in different headache types: tension type (TTH), cervicogenic (CGH) and myofascial headache (MFH) as drafted by the International Classification of Headache Disorders (ICHD). Not only will these types be compared against each other, they will also be compared to healthy controls (HC). The main research questions are: * Are the criteria drafted by the International Classification of Headache Disorders (ICHD) discriminative for MFH? * Are there differences between the headache types (and healthy controls) in pain \& disability scores, range of motion (ROM), muscle strength, muscle elasticity and hyperalgesia (=pain pressure threshold, PPT)? Participants will : * Fill out questionnaires about their pain and disability; * Be clinically investigated by a physiotherapist (anamnesis, inspection, examination of movement and structures of the neck and head); * Undergo a testing battery including neck ROM, neck muscle strength \& elasticity and PPT measurement of the C2 processus spinosus, the bilateral upper trapezius muscle and the tibialis anterior muscle of the dominant leg. 2. The goal of this randomized controlled study is to investigate the additional effect of dry needling in the treatment of MFH patients, as compared to a treatment consisting of manual techniques only. The main question it aims to answer is: * Does manual therapy combined with dry needling provide an additional effect on pain, disability and functional outcomes in MFH patients, as compared to manual therapy alone? After the baseline test (see part 1), participants with MFH will be randomly divided to receive 4 sessions over 4 weeks of MT or MT + DN. Hereafter, the baseline test is repeated at 1 week and 3 months post-treatment.

CONDITIONS

Official Title

The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Fewer than 15 headache days per month
  • More than 5 headache episodes that cause difficulty
  • Average headache pain score greater than 2 out of 10
  • No history of whiplash
  • No serious structural pathology
  • No previous surgeries in the head, neck, or shoulder region
  • Meet the International Classification of Headache Disorders (ICHD) criteria for myofascial headache to join the randomized trial
Not Eligible

You will not qualify if you...

  • Diagnosed migraine or maximum score on the Headache Screening Questionnaire
  • Chronic headache with more than 15 headache days per month
  • New headache onset with fewer than 5 episodes
  • History of whiplash or related disorders
  • Serious structural pathology confirmed by imaging
  • Widespread pain with a total score of 7 or more out of 10
  • Cardiovascular, metabolic, systemic, or neurological diseases
  • Fibromyalgia or Chronic Fatigue Syndrome
  • Past surgery in the head, neck, or shoulder area
  • Probable or definite neuropathic pain
  • Headache caused by trauma
  • Pregnancy, recent childbirth, or breastfeeding within the last year
  • Psychiatric illness or depression currently treated by a psychiatrist
  • Body mass index over 30
  • Use of heavy blood thinners or anticoagulants
  • High risk of infection or skin conditions in the neck area
  • Epilepsy
  • Allergies to latex or nickel
  • Fear of needles

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitair ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

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Research Team

I

Indra De Greef

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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