Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-22

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Radiculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No