Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression

NCT05310578 · tracked via the Priya Life Science Sweden tracker

Sponsor

Linkoeping University

Phase

Observational

Started

2022-08-22

Last updated

2026-09-02

Condition(s) studied

Cervical Radiculopathy

Investigational drug(s) / intervention(s)

Posterior cervical foraminotomy (with our without laminectomy)

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Neck DisabiIity Index; 0-100% (0% = No disability) — Change from baseline to 24 months postoperatively
To measure neck-specific disability

Trial sites (3)

Facility	City	Region	Status
Neuro-ortopediska kliniken	Jönköping	Sweden	Recruiting
Neurosurgery clinic	Linköping	Sweden	Recruiting
Ryggkirurgiskt Centrum	Stockholm	Sweden	Recruiting