The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

  • STATUS
    Recruiting
  • End date
    May 15, 2024
  • participants needed
    60
  • sponsor
    NYU Langone Health
Updated on 19 April 2022

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.

Details
Condition Cervical Spine Disease, Psychological Impairment
Treatment Cognitive behavioral therapy, Sham Therapy, Sham Therapy
Clinical Study IdentifierNCT03183713
SponsorNYU Langone Health
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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 classification: C2-C7 SVA > 8cm, Horizontal Gaze < -10 or > 25, T1S-CL > 20, myelopathy (JOA score <10) or severe adult spinal deformity based on SRS-Schwab classification (PI-LL > 20, PT >30, SVA > 90 mm)
Undergoing simultaneous treatment for thoracolumbar spine related diagnoses at the time of enrollment History of any spinal surgery within the last 6 months
Patients with neck pain attributable to trauma, idiopathic deformity, neoplasm, osteoporosis, or other medical condition
Unlikely to comply with the follow-up evaluation schedule
Subject has recent history of chemical substance dependency that may impact the outcome or study participation
Exclusion Criteria for patients with zero risk
Contraindicated to surgical treatment of the cervical spine
Prior cervical fusion
Evidence of severe cervical spinal deformity based on Ames classification: C2-C7 SVA > 8cm, Horizontal Gaze < -10 or > 25, T1S-CL > 20, myelopathy (JOA score <10) or severe adult spinal deformity based on SRS-Schwab classification (PI-LL > 20, PT >30, SVA > 90 mm)
Undergoing simultaneous treatment for thoracolumbar spine related diagnoses at the time of enrollment History of any spinal surgery within the last 6 months
Patients with neck pain attributable to trauma, idiopathic deformity, neoplasm, osteoporosis, or other medical condition
Unlikely to comply with the follow-up evaluation schedule
Subject has recent history of chemical substance dependency that may impact the outcome or study participation
Subject has a significant psychosocial disturbance or psychiatric history that may impact the outcome or study participation including a DRAM score over 33
Active infection
Systemic infection (AIDS, HIV, or active hepatitis)
Active litigation
Presence of inflammatory spinal disease (e.g. chronic autoimmune conditions, ankylosing spondylitis, DISH, Rheumatoid Arthritis)
Concurrent Spinal or pelvic fracture
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