Cervical brachialgia Nervous System Diseases Cervical brachialgia
Conditions
Interventions
Participants will be randomly allocated to one of two groups. Each group will receive a different operation - one group will receive posterior cervical foraminotomy (PCF), which involves operating thr
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Diagnosis of unilateral cervical brachialgia as confirmed by MRI or CT myelogram taken within the last 12 months 3. Symptoms of cervical brachialgia present for at least 6 weeks 4. Single level nerve entrapment 5. Postero-lateral disc and/or foraminal narrowing 6. Failed conservative management (including but not limited to medication, physiotherapy, modification of daily activities) 7. Able and willing to comply with the terms of the protocol, including quality of life questionnaires 8. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Cervical disc causing cord compression 2. Cervical myelopathy 3. Bilateral cervical brachialgia 4. Previous cervical spine surgery 5. Professionals where a hoarse voice would be exceptionally significant (e.g. singers or speakers) 6. Skin disease at surgical sites (e.g. eczema) 7. Pregnancy 8. Cervical deformity 9. Not suitable for anterior cervical discectomy (ACD) 10. Not suitable for posterior cervical foraminotomy (PCF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck pain, assessed using the Neck Disability Index (NDI) at the baseline and 52 weeks post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare PCF and ACD in terms of: 1. Neck and upper limb pain including the shoulder, arm and hand assessed using Numerical Rating Scales, and neuropathic pain (including dysesthetic pain) assessed using the PainDETECT tool over 52 weeks post-surgery 2. Dysphagia (difficulty swallowing) and globus (sensation of a lump in the throat) over 52 weeks post-surgery as assessed by the participant-completed Eating Assessment Tool (EAT-10) and the Glasgow and Edinburgh Throat Score (GETS) questionnaires 3. Hoarse voice over 52 weeks post-surgery, assessed by the participant completed Voice Handicap Index-10 (VHI-10) and at 6 weeks for a sub-set of participants that have a central Grade, Roughness, Breathiness, Asthenia and Strain (GRBAS scale) assessment of their recorded voice 4. Extent and severity of a patient’s spinal cord function, including upper limb nerve root function, using the American Spinal Injury Association (ASIA) score at 1 day and 6 weeks post-surgery 5. Incidence of revision surgery, collected on a case report form (CRF) over 52 weeks post-surgery 6. Incidence of surgical complications, collected on a CRF up to 6 weeks post-surgery 7. Cost-effectiveness, assessed by a health economist over 52 weeks post-surgery | — |
Countries
England, United Kingdom
Outcome results
None listed