IHS Classification ICHD-3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: - age 18-55 years - unilateral or bilateral headache conforming to ICHD-II for more than 3 months. - Neck Disability Index (NDI score) above 15% - limited flexion-rotation test (FRT) of = 32° to one side.
Exclusion criteria
Exclusion criteria: - congenital developmental disorders - existing rheumatic diseases and tumour diseases - condition following surgery in the cervical, head and jaw region - cortisone or anticoagulant medication - existing arterial hypertension - chronic pain condition - pregnancy - cervical instability - radiculopathy/myelopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether OMT versus placebo achieves significant and clinically relevant improvements (MCID) in Neck Disability Index (NDI) in patients with CGH. Measured at baseline T0, before first treatment T1, T2, T3, and at follow-up T4 after the three-month treatment-free interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate whether OMT achieves significant and clinically relevant improvement in range of motion in the C1-2 motion segment compared to placebo in patients with CGH. Range of motion was assessed with the flexion-rotation test, measured by CROM (Cervical Range of Motion) in degrees. Examined at baseline T0, before first treatment T1, immediately after T2, before T3, and at follow-up T4 after the three-month treatment-free interval. | — |
Countries
Austria, Germany, Switzerland
Contacts
Institut für Osteopathie Oberharz