Headache Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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...) |
Country | Name | City | State |
---|---|---|---|
Belgium | University Ghent - campus UZ Ghent - Rehabilitation Sciences B3 | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. | Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. | Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. |
immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. | Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. |
Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. |
Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. |
Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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. |
Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. | |
Secondary | 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) | Baseline, immediately after the intervention (needling + manual therapy), 1 week after the needling intervention. |
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