Investigating the role of advanced MR imaging in assessing patients with trapped nerves in the neck

Not Applicable

Completed

• Conditions: Cervical foraminal stenosis leading in patients with radiculopathy; Musculoskeletal Diseases; Radiculopathy

• Registration Number: ISRCTN43263110
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-19
• Study Completion: 2023-08-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age over 18 years
2. Diagnosis of brachialgia
3. Able to provide fully informed written consent
4. Able to lie flat for 1 hour in an MRI scanner
5. Awaiting either an anterior cervical discectomy or a posterior cervical foraminotomy for brachialgia
6. Females of childbearing age must be using effective contraception
7. Sufficient understanding of English to participate in the trial

Exclusion Criteria

1. Cervical myelopathy
2. Radiological evidence of cord compression
3. History of cervical trauma
4. Evidence of suspected or histologically proven tumour
5. Previous cervical spine surgery
6. Non-MRI compatible implantable device e.g. pacemaker
7. Unable to have MRI scan due to claustrophobia
8. Female participants must not be pregnant and if of childbearing age must be using adequate contraception

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-rated disability assessed using Neck Disability Index (NDI) at 6 weeks post-surgery

Secondary Outcome Measures

Name	Time	Method
1. Self-rated disability assessed Neck Disability Index (NDI) at 1 day post-surgery<br>2. Pain intensity assessed using Numerical Rating Scales for neck and upper limb pain 1 day and 6 weeks post-surgery.<br>3. Neuropathic pain assessed using PainDETECT at day 0 and at 1 day and 6 weeks post-surgery<br>4. Extent and severity of spinal cord and upper limb functional impairment assessed using a restricted version of the ASIA score at the pre-operative assessment and at 1 day and 6 weeks post-surgery<br>5. Complications occurring during the initial trial operative procedure and postoperative complications recorded up to 6 weeks post-surgery