The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
Primary Purpose
Cervical Spine Disease, Psychological Impairment
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sham Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spine Disease
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Comparison Group
Sham Treatment
CBT
Arm Description
Patients with a zero risk score will serve as a comparison group (N=20).
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Outcomes
Primary Outcome Measures
Distress and Risk Assessment Method (DRAM)
The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed.
Pain Catastrophizing Scale (PCS)
The pain catastrophizing scale quantifies an individual's pain experience, their tendency to magnify the threat value of pain, and their ability to prevent pain-related thoughts surrounding a painful event.
Outcome Expectation question (OEQ)
The OEQ will be a single item question: "I strongly believe that I will recover quickly from my surgery. Responses are score on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome expectations have been shown to be one of the strongest psychological predictors affecting recovery from musculoskeletal injuries.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183713
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Disease, Psychological Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
Patients with a zero risk score will serve as a comparison group (N=20).
Arm Title
Sham Treatment
Arm Type
Active Comparator
Arm Description
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Psychologically symptomatic patients will then be randomized to 4-8 weeks of placebo phone calls (Group PS-PL-Sx) or 4-8 weeks of cognitive behavior therapy treatment (PS-CBT-Sx) based on a 1:1 randomization ratio. Subjects randomized to receive CBT before surgery will proceed to 6 sessions given within 4-8 weeks by a licensed psychologist specializing in pain. CBT sessions will be 30 minutes in length, and focus on empirically supported behavior management, problem solving, cognitive restructuring, and relaxation training. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone.
Intervention Type
Behavioral
Intervention Name(s)
Sham Therapy
Intervention Description
Study nurse will conduct six sessions (30 minutes/ session) over a 4-8 week time period. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone. Sham sessions will entail how to prepare for surgery and expectations for recovery, and will go over content that the treatment and control groups will receive in handout form.
Primary Outcome Measure Information:
Title
Distress and Risk Assessment Method (DRAM)
Description
The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed.
Time Frame
2 Years
Title
Pain Catastrophizing Scale (PCS)
Description
The pain catastrophizing scale quantifies an individual's pain experience, their tendency to magnify the threat value of pain, and their ability to prevent pain-related thoughts surrounding a painful event.
Time Frame
2 Years
Title
Outcome Expectation question (OEQ)
Description
The OEQ will be a single item question: "I strongly believe that I will recover quickly from my surgery. Responses are score on a 5-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome expectations have been shown to be one of the strongest psychological predictors affecting recovery from musculoskeletal injuries.
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Passias, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
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