CompletedNot Applicable

The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

United States48 participantsStarted 2017-06-05

Plain-language summary

This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be used to modify yellow flags in spine patients. All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal of this study is to unmask the relationship between psychological distress and clinical outcomes in patients undergoing surgical treatment for cervical degenerative disease resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness of a brief psychological intervention on subset of patients who screen positive for psychological distress prior to their surgeries.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients at Risk: * Diagnosed of primary symptomatic cervical degenerative disc disease confirmed with appropriate imaging studies. * Etiologies will be limited to cervical disc herniation, spinal stenosis, low-grade (I and II) spondylolisthesis, spondylosis and degenerative disc disease. * Will be undergoing elective cervical spine surgery, not to exceed 5 levels. * Presence of both axial (neck pain) and appendicular (arm pain/dysesthesia/weakness) symptoms, regardless of proportion * Subject must be able to be contacted by telephone during study participation * NDI \> 20% * Read and comprehend English Inclusion Criteria for patients with zero risk: * Diagnosed of primary symptomatic cervical degenerative disc disease confirmed with appropriate imaging studies. * Etiologies will be limited to cervical disc herniation, spinal stenosis, low-grade (I and II) spondylolisthesis, spondylosis and degenerative disc disease. * Will be undergoing elective cervical spine surgery, not to exceed 5 levels. * Presence of both axial (neck pain) and appendicular (arm pain/dysesthesia/weakness) symptoms, regardless of proportion * Subject must be able to be contacted by telephone during study participation * NDI \> 20% * Read and comprehend English Exclusion Criteria: Exclusion Criteria for patients at risk: * Contraindicated to surgical treatment of the cervical spine. * Prior cervical fusion * Evidence of severe cervical spinal deformity based on Ames classificati…

What they're measuring

Distress and Risk Assessment Method (DRAM)

Timeframe: 2 Years

Pain Catastrophizing Scale (PCS)

Timeframe: 2 Years

Outcome Expectation question (OEQ)

Timeframe: 2 Years

Trial details

NCT IDNCT03183713

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-10

View on ClinicalTrials.gov More Cervical Spine Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.