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

NCT06100588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-09-19

No results posted yet for this study

Summary

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

  • Tension-Type Headache
  • Cervicogenic Headache
  • Myofascial Headache

Interventions

OTHER

Dry Needling

Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.

OTHER

Manual therapy

Manual therapy comprises stretching of muscles, mobilizations, traction and translation of vertebrae, Sustained Natural Apophyseal Glides (SNAG), dynamic soft tissue mobilization, Muscle Energy Techniques (MET) and home-exercises.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Barbara Cagnie, Prof. Dr. · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100588 on ClinicalTrials.gov