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Recruiting NCT05310578

Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression

— Observational Cervical Radiculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Posterior cervical foraminotomy (with our without laminectomy).
Who it may be relevant to
Registry conditions: Cervical Radiculopathy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study with a 2 Year Follow-up.

Overview

Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression. The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy. This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.

Interventions

  • Procedure Posterior cervical foraminotomy (with our without laminectomy)
    The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord.

Primary outcome measures

  • Neck DisabiIity Index; 0-100% (0% = No disability) [Time frame: Change from baseline to 24 months postoperatively]
Secondary outcome measures (12)
  • Numeric Rating Scale; 0-10 (0 = No pain/dizziness) [Time frame: Change from baseline to 24 months postoperatively]
  • Frequency of symptoms (5-grade scale from never to always) [Time frame: Change from baseline to 24 months postoperatively]
  • Specific questions regarding headache and dizziness [Time frame: Change from baseline to 24 months postoperatively]
  • Dizziness Handicap Inventory Scale; 0-100 (0 = no disability) [Time frame: Change from baseline to 24 months postoperatively]
  • Short Form Headache Impact test; 36-78 (36 = no impact) [Time frame: Change from baseline to 24 months postoperatively]
  • Core outcome measure Index for neck; 0-10 (0 = good function) [Time frame: Change from baseline to 24 months postoperatively]
  • Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy). [Time frame: Change from baseline to 24 months postoperatively]
  • Odom; 7-point scale (restored/much better to much worse) [Time frame: Change from baseline to 24 months postoperatively]
  • Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored). [Time frame: Change from baseline to 24 months postoperatively]
  • Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear). [Time frame: Change from baseline to 24 months postoperatively]
  • Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing) [Time frame: Change from baseline to 24 months postoperatively]
  • Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy) [Time frame: Change from baseline to 24 months postoperatively]

Eligibility criteria

Inclusion criteria

  • Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI contraindicated) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
  • Posterior cervical decompression as foraminotomy with our without laminectomy
  • At least 3 months of persistent arm pain
  • Age 18-75 years

Exclusion criteria

  • Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
  • Previous surgery of cervical spine
  • Previous fracture or dislocation of the cervical spine
  • Malignancy or benign spinal tumor (eg, neuromas)
  • Spinal infection
  • Previous spondylodiscitis
  • Servere mental disorder
  • Known alcohol or drug abuse
  • Lack of ability to write/comprehend/express oneself in Swedish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 3 centers
  • Neuro-ortopediska kliniken — Jönköping
  • Neurosurgery clinic — Linköping
  • Ryggkirurgiskt Centrum — Stockholm

Identifiers

NCT: NCT05310578 · CR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗