The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain Catastrophizing Scale (PCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Sham Therapy (Behavioral)
Comparison Group
Patients with a zero risk score will serve as a comparison group (N=20).
干预措施: Cognitive Behavioral Therapy (Behavioral)
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).
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Pain Catastrophizing Scale (PCS)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点