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

NCT06100588 | Recruiting

• 1 other identifier: ONZ-2023-0377
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

This project comprises two studies; a cross-sectional study and a randomized controlled trial.

• 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.
• 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

Keywords

Dry Needling; Manual Therapy; Headache

Outcome Measures

Primary Outcomes (1)

• Headache Disability Inventory (HDI)

  The HDI is a 25-item questionnaire of which the questions focus on two categories. There are 13 questions related to the emotional effects and 12 questions on the functional effects of headache complaints. There are 3 answer options: yes (4 points), sometimes (2 points), no (0 points). The sum (maximum 100) gives an impression about the self-perceived limitations as a result of headache. The higher the score, the greater the hindrance caused by headache.

  Baseline; 1 week, 3 months, 6 months, 12 months post-treatment

Secondary Outcomes (12)

• Neck Disability Index (NDI)

  Baseline; 1 week, 3 months, 6 months, 12 months post-treatment

• Numeric Pain Rating Scale (NPRS)

  Baseline; right before each treatment session; 1 week, 3 months, 6 months, 12 months post-treatment

• Range of Motion (ROM)

  Baseline; 1 week and 3 months post-treatment

• Muscle strength (Fm)

  Baseline; 1 week and 3 months post-treatment

• Pressure Pain Threshold (PPT)

  Baseline; 1 week and 3 months post-treatment

Study Arms (2)

MT + DN

EXPERIMENTAL

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.

Other: Dry Needling; Other: Manual therapy

MT alone

ACTIVE COMPARATOR

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.

Other: Manual therapy

Interventions

Dry Needling 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.

MT + DN

Manual therapy 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 + DN; MT alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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

You may not qualify if:

• 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
• Usage of heavy blood thinners or anti-coagulants (e.g. Marcoumar, Marevan, Sintrom)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Universitair ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Tension-Type Headache; Post-Traumatic Headache; Headache

Interventions

Dry Needling; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Barbara Cagnie, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indra De Greef

CONTACT

+32 9 332 56 35; indra.degreef@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Particpants will be randomly assigned to either of the following groups: * Treatment with manual therapy; * Treatment with manual therapy in combination with dry needling.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)