The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

NCT03183713 | Completed

• 1 other identifier: 16-02144
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spine Disease; Psychological Impairment

Outcome Measures

Primary Outcomes (3)

• 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.

  2 Years

• 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.

  2 Years

• 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.

  2 Years

Study Arms (3)

Comparison Group

ACTIVE COMPARATOR

Patients with a zero risk score will serve as a comparison group (N=20).

Behavioral: Cognitive Behavioral Therapy

Sham Treatment

ACTIVE COMPARATOR

All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).

Behavioral: Sham Therapy

CBT

ACTIVE COMPARATOR

All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20).

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

CBT; Comparison Group

Sham Therapy BEHAVIORAL

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.

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter Passias, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: June 5, 2017
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)