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Neck Pain, PosteriorNCT05074381

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

A study testing Dry Needling in people with Neck Pain, Posterior and Headache, run by University Ghent at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Dry Needling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteBelgium
Study dates
1 Mar 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
  • 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
  • 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
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  • 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

Who cannot join

  • 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
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  • 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...)

Trial locations and contacts

1 site in 1 country.

Barbara Cagnie, Prof. contact

+32 9 332 52 65

Barbara.Cagnie@UGent.be

Belgium1 site, 1 recruiting
  • University Ghent - campus UZ Ghent - Rehabilitation Sciences B3

    Ghent, 9000

    Prof. Dr. Cambier, 093322660, Dirk.Cambier@UGent.be

    Recruiting

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Dry Needling, Sham Needling
Keywords
Dry Needling, Sham Needling, Myofascial Pain Syndrome, M. Obliquus Capitis Inferior
Medical subject headings
Neck Pain, Headache, Mobility Limitation, Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry NeedlingOther

    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

  • Sham NeedlingOther

    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.

Study groups in NCT05074381
Study groupRoleWhat they receive
Dry needlingExperimentalA 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.
Receives: Other: Dry Needling
Sham needlingSham comparatorA 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.
Receives: Other: Sham Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)
  1. Changes in headache pain intensity

    Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale (NRS).

    Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) at baseline, immediately after dry or sham needling + manual therapy and 1 week after the intervention.

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

  2. Changes in neck related disability

    Changes in neck disability scores after dry needling, compared to sham needling, will be assessed by the Neck Disability Index. The Neck Disability Index consists of 10 questions, each with 6 answer options with concomitant scores ranging from 0 to 5, which makes the total score of the NDI on 50. A score between 5 and 14 represents a mild disability, whereas a score between 15 and 24 is interpreted as a moderate disability. NDI scores of 25 or higher reflect a severe disability. Subjects will have to report their actual disability complaints at baseline, immediately after dry or sham needling + manual therapy and 1 week after the intervention.

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

  3. Changes in headache related disability

    Changes in headache disability scores after dry needling, compared to sham needling, will be assessed by the Headache Disability Index. The Headache Disability Index consists of 25 questions which can be answered with yes (4 points), sometimes (2 points) and no (0 points). A total score of 10-28 is considered to indicate mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability. Subjects will have to report their actual disability complaints at baseline, immediately after dry or sham needling + manual therapy and 1 week after the intervention.

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

  4. Changes in Global Perceived Effect

    Changes in Global Perceived Effect scores after dry needling, compared to sham needling, as assessed by the Global Perceived Effect Scale. This scale consists of 7 scores (ranging from 1 (very much better) to 7 (very much worser).

    Subjects will have to report their global perceived effect at baseline, immediately after dry or sham needling + manual therapy and 1 week after the intervention.

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

  5. Changes in headache impact.

    Changes in headache impact after dry needling, compared to sham needling, as assessed by the Headache Impact Test (HIT-6) Subjects will have to report their headache impact at baseline, immediately after dry or sham needling + manual therapy and 1 week after the intervention.

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

  6. Changes in global cervical mobility after dry needling or sham needling.

    Changes in global cervical mobility after dry needling or sham needling will be assessed at baseline, immediately after the intervention (needling + manual therapy) and 1 week after treatment. Measurements will be registered with the digital EasyAngle Goniometer (Meloq).

    The change in global cervical mobility will be expressed in degrees.

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

  7. Change in Pain Pressure Thresholds (PPTs)

    Changes in PPTs after dry needling or sham needling will be assessed at baseline, immediately after the intervention (needling + manual therapy) and 1 week after treatment. Measurements will be registered with the digital hand-held pressure algometer (Wagner FPX 25 Force Gage). The change in PPTs will be expressed in Newton.

    To standardize the pressure applied by the investigator, the same investigator always stabilized his wrist with his other hand. The PPT assessment was performed two times with a 30-second break between each application and the pressure was increased by 1N/s until the patient reported the pressure as unpleasant. This pressure was taken as PPT expressed in Newton (N); and the average will be taken of the three measurements on the spinous process of C2 and the Upper Trapezius Muscle.

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

  8. Changes in joint position error

    Changes in joint position error after dry needling or sham needling will be assessed at baseline, immediately after the intervention (needling + manual therapy) and 1 week after treatment. Measurements will be registered with the digital Motion Guidance Laser.

    The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement.

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

  9. Motor control of the cervical spine (craniocervical flexion test)

    The Craniocervical flexion test (CCFT) is a clinical test of neuromotor control including the activation and endurance of the deep flexors of the cervical spine. This test involves the subject performing a "yes" like nod which is the anatomical action of the Deep Cervical flexors, against a pressure biofeedback.

    Two subscores will be used: for performance and for endurance of the deep cervical flexors.

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

  10. Psychosocial headache related parameters: central sensitization, pain catastrophizing, pain coping and pain related fear.

    Psychosocial related parameters: Central Sensitization Index (CSI) + Pain Catastrophizing Scale (PCS) + Pain Coping Strategies (PCI) + Pain Related Fear: Tampa Scale of Kinesiophobia (TSK)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05074381
Sponsor's protocol ID
BC-10474
Status last verified
Nov 2023
First submitted
29 Sep 2021
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling in people with Neck Pain, Posterior and Headache, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barbara Cagnie, Prof. (+32 9 332 52 65, Barbara.Cagnie@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Atlanto-axial rotational mobility after dry needling or sham needling assessed by the flexion-rotation test. (time frame: Baseline, Immediately after needling (DN or SN), immediately after manual therapy, 1 week after the needling intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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