Clinical trial NCT06100588: The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tension-Type Headache
Cervicogenic Headache
Myofascial Headache
Keywords: Dry Needling
Manual Therapy
Headache
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Particpants will be randomly assigned to either of the following groups:

* Treatment with manual therapy;
* Treatment with manual therapy in combination with dry needling.
Primary purpose: TREATMENT

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.

.

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

Primary outcomes:
measure: Headache Disability Inventory (HDI)
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline; right before each treatment session; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Range of Motion (ROM)
timeFrame: Baseline; 1 week and 3 months post-treatment
measure: Muscle strength (Fm)
timeFrame: Baseline; 1 week and 3 months post-treatment
measure: Pressure Pain Threshold (PPT)
timeFrame: Baseline; 1 week and 3 months post-treatment
measure: Muscle Elasticity
timeFrame: Baseline; 1 week and 3 months post-treatment
measure: Global Perceived Effect (GPE)
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Central Sensitization Index (CSI).
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Pain Coping Inventory(PCI).
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
measure: Tampa Scale of Kinesiophobia (TSK).
timeFrame: Baseline; 1 week, 3 months, 6 months, 12 months post-treatment
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair ziekenhuis Gent
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: