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

NCT ID: NCT06100588

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2027-12-31

Brief 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.

Detailed 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 clinical 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, 50 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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Conditions

Tension-Type Headache; Cervicogenic Headache; Myofascial Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MT + DN

4 treatment sessions of 20 minutes manual therapy will be given over 4 weeks (1session/week). The techniques will be tailored to the patients needs, and will exclude 'High Velocity Low Amplitude' manipulations.

In addition, a maximum of 4 muscles will be treated by means of dry needling in at least 3 sessions, based on the pain pattern of the patient.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: OTHER

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.

Manual therapy

Intervention Type: OTHER

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.

MT alone

4 treatment sessions of 20 minutes manual therapy will be given over 4 weeks (1session/week). The techniques will be tailored to the patients needs, and will exclude 'High Velocity Low Amplitude' manipulations.

Group Type: ACTIVE_COMPARATOR

Manual therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• < 15 headache days per month
• > 5 episodes of the headache that gives hindrance
• Mean NPRS score for headache episodes >2/10
• No history of whiplash
• No serious structural pathology
• No previous surgeries in the head/neck/shoulder region

To be included in the RCT-part of the study:

• Fitting the ICHD criteria for MFH

Exclusion Criteria

• Diagnosis of migraine by a neurologist or as confirmed via the Headache Screening Questionnaire (HSQ) with the maximum score of 8/8.
• Chronic headache (>15 headache days/month)
• Newly onset headache (<5 previous episodes of new headache type)
• Whiplash or whiplash associated disorders
• Serious structural pathology (confirmed by medical imaging)
• Pain on both sides of the body, above and under the waist, (with a total score of 7 or more out of 10) (=Widespread pain)
• Cardiovascular/metabolic/systemic/neurological diseases
• Fibromyalgia, Chronic Fatigue Syndrome
• History of surgery in the head/neck or shoulder region
• Probable or definite neuropathic pain (according to the classification of Finnerup et al.)
• Traumatic onset of the complaints
• Pregnancy/given birth/breastfeeding in the preceding year
• Psychiatric illnesses or depression diagnosed by a psychiatrist and currently treated by a psychiatrist and/or medication.
• BMI >30

For all of RCT-patients, the following criteria will also lead to exclusion due to the dry needling intervention:

• Usage of heavy blood thinners or anti-coagulants (e.g. Marcoumar, Marevan, Sintrom)
• High risk of infection because of comorbidities (e.g. HIV, diabetes) or skin conditions in the neck region (e.g. psoriasis)
• Epilepsy
• Allergies for latex, nickel
• Needle phobia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Cagnie, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Universitair ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Indra De Greef

Role: CONTACT

indra.degreef@ugent.be

+32 9 332 56 35

Facility Contacts

Indra De Greef, MSc

Role: primary

indra.degreef@ugent.be

Other Identifiers

ONZ-2023-0377

Identifier Type: -

Identifier Source: org_study_id