RecruitingNot ApplicableNCT06100588

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

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.


Sponsor

University Ghent

Enrollment

152 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • < 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 Criteria20

  • 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

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Interventions

OTHERDry 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.

OTHERManual 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.


Locations(1)

Universitair ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

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NCT06100588