Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression

NCT05310578 | Recruiting

• 1 other identifier: CR
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Neck DisabiIity Index; 0-100% (0% = No disability)

  To measure neck-specific disability

  Change from baseline to 24 months postoperatively

Secondary Outcomes (20)

• Numeric Rating Scale; 0-10 (0 = No pain/dizziness)

  Change from baseline to 24 months postoperatively

• Frequency of symptoms (5-grade scale from never to always)

  Change from baseline to 24 months postoperatively

• Specific questions regarding headache and dizziness

  Change from baseline to 24 months postoperatively

• Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)

  Change from baseline to 24 months postoperatively

• Short Form Headache Impact test; 36-78 (36 = no impact)

  Change from baseline to 24 months postoperatively

Interventions

Posterior cervical foraminotomy (with our without laminectomy) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with cervical radiculopathy scheduled to undergo foraminotomy with our without laminectomy at one of three specific neurosurgery or neuroortopedic clinics in south of Sweden. Individuals are preoperative screened for eligibility and those who meet the criteria to participate in the study are asked for informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (3)

Neuro-ortopediska kliniken

Jönköping, Sweden

RECRUITING

Neurosurgery clinic

Linköping, Sweden

RECRUITING

Ryggkirurgiskt Centrum

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Anneli Peolsson, PhD

  Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jard Svensson, MSc

CONTACT

+46101034026; jard.svensson@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 5, 2022
• Study Start: August 22, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)