Clinical trial NCT05310578: Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression
Official title: Functioning in Individuals with Cervical Radiculopathy After Posterior Cervical Decompression: a Prospective Multicenter Observational Study with a 2 Year Follow-up.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Radiculopathy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-04-05
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Neck DisabiIity Index; 0-100% (0% = No disability)
timeFrame: Change from baseline to 24 months postoperatively
Secondary outcomes:
measure: Numeric Rating Scale; 0-10 (0 = No pain/dizziness)
timeFrame: Change from baseline to 24 months postoperatively
measure: Frequency of symptoms (5-grade scale from never to always)
timeFrame: Change from baseline to 24 months postoperatively
measure: Specific questions regarding headache and dizziness
timeFrame: Change from baseline to 24 months postoperatively
measure: Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)
timeFrame: Change from baseline to 24 months postoperatively
measure: Short Form Headache Impact test; 36-78 (36 = no impact)
timeFrame: Change from baseline to 24 months postoperatively
measure: Core outcome measure Index for neck; 0-10 (0 = good function)
timeFrame: Change from baseline to 24 months postoperatively
measure: Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy).
timeFrame: Change from baseline to 24 months postoperatively
measure: Odom; 7-point scale (restored/much better to much worse)
timeFrame: Change from baseline to 24 months postoperatively
measure: Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored).
timeFrame: Change from baseline to 24 months postoperatively
measure: Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear).
timeFrame: Change from baseline to 24 months postoperatively
measure: Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)
timeFrame: Change from baseline to 24 months postoperatively
measure: Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)
timeFrame: Change from baseline to 24 months postoperatively
measure: Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety)
timeFrame: Change from baseline to 24 months postoperatively
measure: Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored)
timeFrame: Change from baseline to 24 months postoperatively
measure: Cherkin symptom satisfaction
timeFrame: Change from baseline to 24 months postoperatively
measure: EuroQuol 5D-5L; 5-25 (5 = high health related quality of life)
timeFrame: Change from baseline to 24 months postoperatively
measure: EQ thermometer; 0-100 (0 = low health related quality of life)
timeFrame: Change from baseline to 24 months postoperatively
measure: Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity)
timeFrame: Change from baseline to 24 months postoperatively
measure: International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level)
timeFrame: Change from baseline to 24 months postoperatively
measure: Work Ability Index (categorize to poor, moderate, good and excellent work ability)
timeFrame: Change from baseline to 24 months postoperatively
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Neuro-ortopediska kliniken
city: Linköping
country: Sweden
facility: Neurosurgery clinic
city: Stockholm
country: Sweden
facility: Ryggkirurgiskt Centrum
Study officials:
affiliation: Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy
name: Anneli Peolsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: