The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

NCT ID: NCT03183713

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2024-07-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Comparison Group

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: 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.

Sham Treatment

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

Group Type: ACTIVE_COMPARATOR

Sham Therapy

Intervention Type: 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.

CBT

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: 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.

Interventions

Cognitive Behavioral Therapy

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

Sham Therapy

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.

Intervention Type: BEHAVIORAL

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

• 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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Passias, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-02144

Identifier Type: -

Identifier Source: org_study_id