Dry Needling of the M. Obliquus Capitis Inferior on Rotational Mobility and Headache Related Outcome Measures in CH.

NCT05074381 | Unknown

• 1 other identifier: BC-10474
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An experimental study will be conducted to evaluate the effect of dry needling on the M. Obliquus capitis inferior on rotational mobility and headache realted outcome measures in patients with cervicogenic headache.

Conditions

Neck Pain, Posterior; Headache; Mobility Limitation

Keywords

Dry Needling; Sham Needling; Myofascial Pain Syndrome; M. Obliquus Capitis Inferior

Outcome Measures

Primary Outcomes (1)

• Changes in Atlanto-axial rotational mobility after dry needling or sham needling assessed by the flexion-rotation test.

  Changes in Atlanto-axial rotational mobility after dry needling or sham needling will be assessed by the flexion-rotation test at baseline, immediately after needling (DN or SN); immediately after manual therapy and 1 week after treatment. Measurements will be registered with the digital EasyAngle Goniometer (Meloq). The change in Atlanto-axial rotational mobility after dry needling will be compared with the change Atlanto-axial rotational mobility after sham needling. Atlanto-axial rotational mobility be expressed in degrees.

  Baseline, Immediately after needling (DN or SN), immediately after manual therapy, 1 week after the needling intervention.

Secondary Outcomes (10)

• Changes in headache pain intensity

  Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.

• Changes in neck related disability

  Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.

• Changes in headache related disability

  Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.

• Changes in Global Perceived Effect

  immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.

• Changes in headache impact.

  Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.

Study Arms (2)

Dry needling

EXPERIMENTAL

A single dry needling session will be performed with the subject lying in prone position. A trained physiotherapist will penetrate the needle into skin surface, fascia,into the muscle tissue at the MTrP location of the M. Obliquus Capitis Inferior, and will move the needle up and down to elicit local twitch responses.In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct. Afterwards, a rotational muscle energy technique will be applied to the atlanto-axial level.

Other: Dry Needling

Sham needling

SHAM COMPARATOR

A single sham needling session will be performed with the subject lying in prone position. A trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated. Afterwards, a rotational muscle energy technique will be applied to the atlanto-axial level.

Other: Sham Needling

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, leadi

Dry needling

Sham Needling OTHER

During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.

Sham needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
• A. Any headache fulfilling criterion C B. Clinical and/or imaging evidence1 of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache2
• C. Evidence of causation demonstrated by at least two of the following:
• headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
• headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
• cervical range of motion is reduced, and headache is made significantly worse by provocative manœuvres
• headache is abolished following diagnostic blockade of a cervical structure or its nerve supply D. Not better accounted for by another ICHD-3 diagnosis3;4;5.
• Age: 18-65 years
• Headache for at least 1 day/week for at least 3 months
• Limited mobility of the neck
• Positive flexion-rotation test (\<32 degrees on the left/right side or a difference of 10 degrees or more between left and right side)
• NRS \> 3/10

You may not qualify if:

• Primary headache forms: migraine, TTH
• Other secondary headaches that do not comply with the ICDH-3 criteria for CH
• Whiplash or other traumatic incident in the past
• Pregnancy or given birth in the last year
• Previous head, neck or shoulder surgery
• Cervical radiculopathy complaints
• Fear of needles
• Receiving other treatments for headache or neck pain (physical therapy/ostheopathy/chiropraxie...) in the previous month
• All possible contra-indications for dry needling (taking anti-coagulantia; infectional diseases; skin abnormalties in the head/neck-region; epilepsia; allergies for latex, nickel...)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

University Ghent - campus UZ Ghent - Rehabilitation Sciences B3

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Neck Pain; Headache; Mobility Limitation; Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Barbara Cagnie, Prof.

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Cagnie, Prof.

CONTACT

+32 9 332 52 65; Barbara.Cagnie@UGent.be

Study Design

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

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)