Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2018
INTERVENTION: 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 through the back of the neck, and the other group will receive anterior cervical discectomy (ACD), which involves operating through the front of the neck. Both operations are standard treatments for cervical brachialgia. Participants will be randomised to either the PCF or ACD group on the day of their surgery. At day 1 post surgery, participants will have routine assessments performed, as well as an ASIA (American Spinal Injury Association) assessment. Participants will also complete a questionnaire pack. Participants will then attend the clinic 6 weeks post surgery for routine clinical assessment as they would as part of standard care, and have another ASIA assessment performed. Participants will then complete a questionnaire pack, and do a voice recording if applicable. On weeks 12, 26, 39 and 52 a questionnaire pack will be sent to participants by post for completion and return by post, participants will be sent email or text reminders if they consented to this on the consent form. 25% of participants will be selected at registration to provide a voice recording. This will be completed before the operation and 6 weeks after the operation. CONDITION: Cervical brachialgia ; Nervous System Diseases ; Cervical brachialgia PRIMARY OUTCOME: Neck pain, assessed using the Neck Disability Index (NDI) at the baseline and 52 weeks post‐surgery SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 88200ccb1a7ce70cf88eedc4f981295f08112577
First added on: Aug 24, 2024