Clinical trial NCT03183713: The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
Official title: The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Disease
Psychological Impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Distress and Risk Assessment Method (DRAM)
timeFrame: 2 Years
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 2 Years
measure: Outcome Expectation question (OEQ)
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Peter Passias, MD
role: PRINCIPAL_INVESTIGATOR
References: