- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183713
The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
March 1, 2024 updated by: NYU Langone Health
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Moawad
- Phone Number: 646 794 8643
- Email: Mohamed.Moawad@nyumc.org
Study Contact Backup
- Name: Alexandra Lee
- Phone Number: 646 794 8643
- Email: Alex.Lee@nyumc.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Comparison Group
Patients with a zero risk score will serve as a comparison group (N=20).
|
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).
|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 Years
|
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.
|
2 Years
|
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.
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Passias, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2017
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 8, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
March 1, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-02144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Spine Disease
-
Bezmialem Vakif UniversityWithdrawnCervical Disc Disease | Cervical Spine DiseaseTurkey
-
Vanderbilt University Medical CenterCompletedSpinal Fusion | Cervical Spine Degenerative DiseaseUnited States
-
Izmir Katip Celebi UniversityRecruitingExercise | Surgery | Rehabilitation | Cervical Spine DiseaseTurkey
-
Riphah International UniversityCompletedCervical Spine DiseasePakistan
-
University Hospitals Cleveland Medical CenterTerminatedLumbar Spine Surgeries | Cervical Spine SurgeriesUnited States
-
Imperial College Healthcare NHS TrustImperial College London; The Wellington Hospital, LondonCompleted
-
Michigan State UniversityAmerican Osteopathic AssociationCompleted
-
Michigan State UniversityCompleted
-
Texas Woman's UniversityTexas Society of Allied Health Professions; Texas Spine and Joint HospitalCompletedCervical Spine Degenerative Disc Disease | Fusion of Spine, Cervical RegionUnited States
-
China Medical University HospitalNot yet recruiting
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States