The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2018 |
| Start Date: | June 5, 2017 |
| End Date: | April 3, 2019 |
| Contact: | Mohamed Moawad |
| Email: | Mohamed.Moawad@nyumc.org |
| Phone: | 646 794 8643 |
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Peter Passias, MD
Phone: 646-794-8643
New York University School of Medicine NYU School of Medicine has a proud history that...
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