The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
Keywords
Abstract
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 06/07/2017 |
| Estimated Enrollment Submitted: | 06/07/2017 |
| First Posted: | 06/11/2017 |
| Last Update Submitted: | 05/25/2020 |
| Last Update Posted: | 05/26/2020 |
| Actual Study Start Date: | 06/04/2017 |
| Estimated Primary Completion Date: | 12/29/2020 |
| Estimated Study Completion Date: | 12/29/2020 |
Condition or disease
Intervention/treatment
Behavioral: Cognitive Behavioral Therapy
Behavioral: Sham Treatment
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Comparison Group Patients with a zero risk score will serve as a comparison group (N=20). | |
| Active Comparator: 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). | Behavioral: Sham Treatment 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. |
| Active Comparator: 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). |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Distress and Risk Assessment Method (DRAM) [2 Years]
2. Pain Catastrophizing Scale (PCS) [2 Years]
3. Outcome Expectation question (OEQ) [2 Years]
