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

Tension-Type Headache Clinical Trial

Official title: The Classification of Myofascial Headache: a Cross-sectional Study. The Added Value of Dry Needling in the Treatment of Myofascial Headache: a Randomized Controlled Trial.

Status Recruiting

Clinical Trial 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 treshold, 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.

Clinical Trial Description

Although tension-type headache (TTH) and cervicogenic headache (CGH) are classified as two distinct headache types according to the International Classification of Headache Disorders (ICHD), there are many cases in which overlap between these two types exists, and for whom clinical diagnosis can be challenging. Peripheral activation or sensitization of myofascial nociceptors is suggested as a potential mechanism in both categories, and as a consequence the ICHD (3rd edition - 2018) has recently drafted an alternative diagnosis: headache attributed to cervical myofascial pain (MFH). However, clear clinical criteria for this diagnosis are currently lacking.

By subjecting CGH, TT, MFH and HC (34 participants of each) to the ICHD criteria and a clincial investigation, we will look at similarities and differences and the ability of the criteria to differentiate the headache types.

Among the several proposed approaches for the treatment of myofascial pain, dry needling (DN) has received particular attention in the last decades. DN is defined as a skilled intervention using a thin needle which is inserted into a painful point in the muscle, also referred to as a trigger point. Although previous studies have indicated that DN may be an effective intervention in the treatment of TTH and CGH, little is known about its (additional) effect on MFH.

Therefore, 90 MFH patients will be recruited. Participants are included based on online questionnaires, a clinical examination of the neck and the ICHD criteria. All participants will receive information and have to sign an informed consent form. Participants will be subjected to baseline assessment, which involves measurements of pain scores (NPRS), hyperalgesia (PPT by algometry), ROM (EasyAngle device) and neck muscle strength measurement (EasyForce device) and neck muscle elasticity measurement using Shear Wave Elastography (SWE). Then, participants will be randomly allocated to either a manual therapy group or a manual therapy + dry needling group. 4 sessions of therapy will be given over 4 weeks time.

1 week and 3 months after the treatment sessions, the baseline measurements will be repeated. After 6 and 12 months, patients will complete questionnaires from home which will give information about pain & disability scores.

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Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache
• Tension-Type Headache

• NCT number: NCT06100588
• Study type: Interventional
• Source: University Ghent
• Contact: Indra De Greef
• Phone: +32 9 332 12 17
• Email: indra.degreef@ugent.be
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Completion date: December 2027