The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

Not Applicable

Completed

• Conditions: Cervical Spine Disease; Psychological Impairment
• Interventions: Behavioral: Sham Therapy; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT03183713
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham Therapy	All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).
Comparison Group	Cognitive Behavioral Therapy	Patients with a zero risk score will serve as a comparison group (N=20).
CBT	Cognitive Behavioral Therapy	All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).

Primary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS)	2 Years	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.
Distress and Risk Assessment Method (DRAM)	2 Years	The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed.
Outcome Expectation question (OEQ)	2 Years	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States