The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03183713 |
Recruitment Status
:
Recruiting
First Posted
: June 12, 2017
Last Update Posted
: April 23, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Spine Disease Psychological Impairment | Behavioral: Cognitive Behavioral Therapy Behavioral: Sham Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Confounding Burden of Psychological Impairments in Cervical Spine Surgery |
Actual Study Start Date : | June 5, 2017 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Comparison Group
Patients with a zero risk score will serve as a comparison group (N=20).
|
Behavioral: 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.
|
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 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.
|
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).
|
Behavioral: 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.
|
- Distress and Risk Assessment Method (DRAM) [ Time Frame: 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.
- Pain Catastrophizing Scale (PCS) [ Time Frame: 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.
- Outcome Expectation question (OEQ) [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183713
Contact: Mohamed Moawad | 646 794 8643 | Mohamed.Moawad@nyumc.org | |
Contact: Alexandra Lee | 646 794 8643 | Alex.Lee@nyumc.org |
United States, New York | |
New York University School of Medicine | Recruiting |
New York, New York, United States, 10016 | |
Contact: Mohamed Moawad 646-794-8643 Mohamed.Moawad@nyumc.org | |
Contact: Alex Lee 646 794 8643 Alex.Lee@nyumc.org | |
Principal Investigator: Peter Passias, MD |
Principal Investigator: | Peter Passias, MD | New York University School of Medicine |
Responsible Party: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03183713 History of Changes |
Other Study ID Numbers: |
16-02144 |
First Posted: | June 12, 2017 Key Record Dates |
Last Update Posted: | April 23, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Spinal Diseases Bone Diseases Musculoskeletal Diseases |