Cervical Spine DiseaseNCT03183713
The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
A study testing Cognitive Behavioral Therapy in people with Cervical Spine Disease and Psychological Impairment, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spine Disease, Psychological Impairment
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- NDI > 20%
- Read and comprehend English
- 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
Who cannot join
- 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
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- Subject has recent history of chemical substance dependency that may impact the outcome or study participation
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Cervical Spine Disease, Psychological Impairment
- Being tested
- Cognitive Behavioral Therapy, Sham Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
Sham TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group | Active comparator | Patients with a zero risk score will serve as a comparison group (N=20). Receives: Behavioral: Cognitive Behavioral Therapy |
| Sham Treatment | Active comparator | All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). Receives: Behavioral: Sham Therapy |
| CBT | Active comparator | All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress and Risk Assessment Method (DRAM)
The DRAM assesses and profiles patients: those showing no psychological distress, those at risk of developing major psychological overlay, and those that are distressed.
Measured: 2 Years
Pain Catastrophizing Scale (PCS)
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.
Measured: 2 Years
Outcome Expectation question (OEQ)
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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start5 Jun 2017
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Passias, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183713
- Sponsor's protocol ID
- 16-02144
- Status last verified
- Sep 2024
- First submitted
- 8 Jun 2017
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Confounding Burden of Psychological Impairments in Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT03183713
- Acronym / sponsor ID
- 16-02144
- Conditions
- Cervical Spine Disease, Psychological Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparison Group | Active comparator | Behavioral: Cognitive Behavioral TherapyPatients with a zero risk score will serve as a comparison group (N=20). |
| Sham Treatment | Active comparator | Behavioral: Sham TherapyAll patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). |
| CBT | Active comparator | Behavioral: Cognitive Behavioral TherapyAll patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyPsychologically 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. | Behavioural | CBT, Comparison Group |
| Sham TherapyStudy 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. | Behavioural | Sham Treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Passias, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Cervical Spine Disease and Psychological Impairment, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress and Risk Assessment Method (DRAM) (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.