Clinical trial NCT05074381: Dry Needling of the M. Obliquus Capitis Inferior on Rotational Mobility and Headache Related Outcome Measures in CH.
Official title: Effect of Dry Needling of the M. Obliquus Capitis Inferior on Rotational Mobility and Headache Related Outcome Measures in Patients With Cervicogenic Headache: a Randomized, Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain, Posterior
Headache
Mobility Limitation
Keywords: Dry Needling
Sham Needling
Myofascial Pain Syndrome
M. Obliquus Capitis Inferior
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Headache is a common and disabling condition. Several primary and secondary headache forms have been described, such as migraine, tension-type headache and cervicogenic headache (CH). In patients with CH; we can see a reffered pain pattern to the head, possibly originating from a source in the (upper)cervical spine. It has been described that nociceptive input, originating from the C1-C3 nervous system may be responsible for pain referal to head and neck regions. Recently, the flexion-rotation test (FRT) has been described as one of the most usefel clinical tests in the clinical testing and research of CH. Other literature showed that the rotational movement during the FRT was diminished in patients with CH and these results were correlated to headache intensity. 5,6

To treat this disabling condition, manual therapy is already known to be an effective treatment strategy. However, the additional value of dry needling is still to be discussed. Since the M. Obliquus capitis inferior (M. OCI) finds its origin on the apex of the spinous processus of C2 and inserts on transverse processus of the atlas (C1); this muscle might be anatomically very relevant to influence rotational mobility in the upper cervical spine. Additionally, this muscle is responsible for proprioception and accurate positioning of the head and neck, due to the presence of a large amount of Golgi bodies and muscle spindles in the muscle. Considering the myofascial pain referal pattern of the M. OCI, a referred pain pattern to the temporal region may be present when active triggerpoints are present.

Previous research already showed some preliminary evidence for positive treatment effects by dry needling of the M. OCI in patients with cervicogenic dizziness and headache.

The goal of this study is to evaluate the effect of a single dry needling intervention of the M. OCI on rotational mobility and headache related parameters, in a group of cervicogenic headache patients with a positive flexion-rotation test (articular mobility test on level C1-C2).

In this experimental study, 40 patients with cervicogenic headache will be recruited. Participants are required to have complaints for at least 3 months. Participants are included based on online questionnaires, a clinical examination of neck and shoulder, and the identification of a MTrP in the M. OCI muscle. All participants will receive information and have to sign an informed consent form.

Participants will be subjected to baseline assessment, which involves questionnaires and measurements of the cervical spine.

Secondly, participants will be randomly allocated to either the dry needling group or a sham needling group. The dry needling group will receive a dry needling treatment at the identified trigger point location (M. OCI - heterolateral to the restricted rotationside) whereas the sham needling group will receive an intervention in which the needle only penetrates the skin but not the fascia and muscle tissue.

Rotational mobility will be evaluated after the needling intervention, afterwards all patients will receive a standardized manual therapy treatment (Muscle Energy Technique). Afterwards, all baseline measurements will be conducted again. This testing will be repeated one week after treatment as well.

Eligibility criteria: Inclusion Criteria:

* 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:

1. headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
2. headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
3. cervical range of motion is reduced, and headache is made significantly worse by provocative manœuvres
4. 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

Exclusion Criteria:

* 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...)

Primary outcomes:
measure: Changes in Atlanto-axial rotational mobility after dry needling or sham needling assessed by the flexion-rotation test.
timeFrame: Baseline, Immediately after needling (DN or SN), immediately after manual therapy, 1 week after the needling intervention.
Secondary outcomes:
measure: Changes in headache pain intensity
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in neck related disability
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in headache related disability
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in Global Perceived Effect
timeFrame: immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in headache impact.
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in global cervical mobility after dry needling or sham needling.
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Change in Pain Pressure Thresholds (PPTs)
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Changes in joint position error
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Motor control of the cervical spine (craniocervical flexion test)
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
measure: Psychosocial headache related parameters: central sensitization, pain catastrophizing, pain coping and pain related fear.
timeFrame: Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent - campus UZ Ghent - Rehabilitation Sciences B3
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, Prof.
role: PRINCIPAL_INVESTIGATOR
References: