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Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing (TRIBECA)

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ClinicalTrials.gov Identifier: NCT03969602
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Maastricht University
Schulthess Klinik
Information provided by (Responsible Party):
Pietro Scarone, Neurocenter of Southern Switzerland

Brief Summary:

Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have not historically been offered these interventions. The aim of our study is to examine whether an intervention targeting pain catastrophizing can reduce the risk of persistent pain and disability after spinal fusion.

Our primary hypothesis is that a perioperative cognitive behavioral intervention with the goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain and disability after spinal fusion surgery in high catastrophizing patients.

To study this hypothesis the investigators will perform a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing 2 cohorts.

Patients aged > 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons and selected for lumbar spinal fusion surgery with decompression will be screened for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2 sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group) or usual care (control group). To limit expectation bias, an educational intervention will be added in the control group.

Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Lumbar Spondylolisthesis Lumbar Instability Spinal Disease Behavioral: Cognitive-behavioral Therapy Other: Biomedical and surgery-specific education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The investigators and research assistants assessing outcomes will be blinded to group assignment. The psychologist/s delivering the CBT and the clinicians delivering the educational intervention in the control group cannot be blinded. Nevertheless, patients will be blinded to study hypotheses and will be informed that the study is examining the comparative benefits of two treatments that are given in addition to usual care and that may potentially improve outcomes. The patients will not be aware of the study hypotheses and will not be informed about the likely association between a high PCS score and lower outcomes after lumbar spinal surgery, neither about the fact that the control intervention (i.e. an educational & exercise intervention that is expected to minimize/cancel any expectation bias) will not address catastrophizing.
Primary Purpose: Treatment
Official Title: The Impact of Cognitive Behavioral Therapy (CBT) on Treatment Outcome After Lumbar Spinal Fusion Surgery in Patients With High Pain Catastrophizing: a Two-center Randomized Controlled Trial of CBT vs. Education Plus Usual Care
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2023

Arm Intervention/treatment
Experimental: Experimental Group
Participants randomized will receive six individual 1-hour sessions of CBT: two sessions before the operation and four after, delivered by a psychologist trained in CBT for chronic pain. The CBT intervention is tailored to reduce pain catastrophizing. Main techniques are: pain education and the influence of cognitions, emotions and behavior on pain and pain disability; identification of catastrophizing cognitions and replacing them with more adaptive cognitions; stress/anxiety reduction by diaphragmatic breathing and progressive muscle relaxation; emotion regulation skills training; cognitive restructuring; coping skills training to combat helplessness and foster a sense of control and self-efficacy for dealing with acute post-operative pain. The four postoperative sessions build on and further extend the skills learned preoperatively. Each session ends with specific homework assignments. All patients receive a homework book and an individually tailored instruction manual.
Behavioral: Cognitive-behavioral Therapy
The biopsychosocial approach of CBT focuses on the complex interaction between psychological, social and biological factors. The biopsychosocial model assumes that health problems are hardly ever limited to just one domain of human experience but by multiple domains of human experience. CBT helps patients understand thoughts and feelings that influence behaviors. It consists of a cognitive aspect and a behavioral aspect. The cognitive aspect is based on Becks cognitive model: the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. A person's cognition has impact on their mood and emotions, their bodily reactions and their behavior. The second part of cognitive behavior therapy focuses on the actual behaviors that are contributing to the problem. The goal of CBT is to identify maladaptive thoughts and change them into more realistic and constructive thoughts to modify feelings and behavior and thereby the experience of pain.
Other Name: CBT

Active Comparator: Control Group
Participants will have six meetings with members of the research team (in person or through telephone). In a first preoperative meeting a member of the team provides verbal information on the preparation for surgery, surgery itself and recovery from surgery, stressing the importance of postoperative exercise. Any questions raised by the patient are discussed. A booklet is provided with information about: structure of the spinal column and spinal diseases; examinations before surgery; the operative environment; surgical procedures; anesthetic procedures; postoperative care and postoperative pain reduction. A second preoperative (telephone) meeting is scheduled to answer any remaining questions. During the postoperative phase, instructions and an exercise manual are provided, Patients keep a diary to record their training activity. Three, six and eight months after discharge patients are contacted by telephone and their training progress is discussed.
Other: Biomedical and surgery-specific education
Biomedical and surgery-specific education preoperatively and an exercise manual postoperatively.

No Intervention: Observational Group (low catastrophizing)
Patients will be routinely prescribed medications for pain control and are referred for physical therapy on an out-patient basis in different sites or an in-patient basis in specialized rehabilitation centers following lumbar spinal fusion surgery, depending on the needs. Typically, a full rehabilitation regime starts 2-3 weeks after surgery. Usual programs involve active spinal mobilization aimed at gradually improving the range of motion, exercises to strengthen spinal deep muscles, and segmentary stretching involving the lower limb and back muscles, together with manual therapy. The patients are also given walking exercises and trained in how to change position.



Primary Outcome Measures :
  1. COMI (Core Outcome Measure Index) [ Time Frame: 12 months post surgery ]
    The COMI comprises a short set of questions used to assess the impact of spinal disorders on multiple patient-orientated outcome domains. It is based on a set of individual items selected from established questionnaires and recommended for standardized use by an international group of experts in the field. It consists of seven items to assess the extent of the patient's back pain and leg pain, difficulties with functioning in everyday life, symptom-specific well-being, general quality of life, and social and work disability. A summary index score from 0 (best health status) to 10 (worst health status) can be computed by averaging the values of the five subscales.


Secondary Outcome Measures :
  1. NRS Pain (The Numeric Rating Scale for Pain) [ Time Frame: 4 days, 8 weeks, 6 and 12 months post surgery ]
    NRS-11 is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. Rating = 0 indicates no pain, rating =1-3 indicates mild pain, rating 4-6 indicates moderate pain while rating 7-10 indicates severe pain.

  2. ODI (Oswestry Disability Index) [ Time Frame: 8 weeks, 6 and 12 months post surgery ]
    The ODI questionnaire is a self-administered set of ten questions assessing the patient's level of pain and function during activities of daily living such as walking, personal care, standing, sleeping, etc. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score as follows: 0%-20%=Minimal disability, 20%-40% = Moderate disability, 40%-60% = Severe disability, 60%-80%= Crippled, 80%-100% = bed bound.

  3. PROMIS (Patient-Reported Outcomes Measurement Information System) for depression [ Time Frame: 8 weeks, 6 and 12 months post surgery ]
    The PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. For the present study, the PROMIS Short Form v1.0 - Depression 8b will be used. This questionnaire, part of the PROMIS depression toolbox, has 8 items that are scored on a 1- 5 scale. For each question, a score of 1 indicates "never" (better score) while a score of 5 indicates "always" (worse score). A total score is obtained by summing the values of the responses to each question, ranging from 8 (low level of depression) to 40 (high level of depression).

  4. PGIC (Patient's global impression of change) [ Time Frame: 8 weeks, 6 and 12 months post surgery ]
    Patients rate their perceived improvement on a 7-point Likert Scale from 1 (very much improved) to 7 (very much worse).

  5. PCS (Pain catastrophizing) [ Time Frame: 8 weeks, 6 and 12 months post surgery ]
    The Pain Catastrophizing Scale (PCS) has 13 items that are scored on a 5-point scale ranging from 0 (never) to 4 (always), providing a total score that can range from 0 to 52.

  6. EQ-5D-5L (The 5-level EuroQol 5 Dimensions) for quality of life [ Time Frame: 8 weeks, 6 and 12 months post surgery ]
    The EQ-5D-5L questionnaire uses a health state classification defining health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, ranging from 11111 (no problems in any of the 5 dimensions) to 55555 (extreme problems in all dimensions). The health states are then converted into a single index value from 0 (worse) to 1 (best).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able to read and speak Italian (site 1) or Dutch (site 2)
  • a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons
  • selected for lumbar spinal fusion surgery with decompression
  • patients with a score of ≥ 24 on the PCS to be randomized to perioperative CBT plus usual care or education plus usual care, required to complete all questionnaires (see study schedule)
  • patients with a score of < 24 will not be randomized to one of the treatment groups but are eligible for preoperative and postoperative assessment
  • are able to provide informed consent and have signed the informed subject consent form

Exclusion Criteria:

  • report plans to undergo major surgery within six months after current lumbar spinal fusion surgery
  • comorbid severe psychiatric conditions
  • known or suspected non-compliance, drug or alcohol abuse
  • inability to follow the procedures of the study, e.g. due to dementia, etc. of the participant
  • the presence of any serious medical comorbidity such as sepsis or cancer that might cause disability or worsen the patient's general health condition
  • pregnancy is an "automatic" exclusion because women who are pregnant are excluded by their physicians from lumbar spinal fusion surgery
  • an opioid intrathecal pump
  • prisoners

Information from the National Library of Medicine

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): NCT03969602


Contacts
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Contact: Pietro Scarone, M.D. +41918116455 pietro.scarone@eoc.ch
Contact: Eva Koetsier, M.D. +41918117595 eva.koetsier@eoc.ch

Locations
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Switzerland
Neurocenter of Southern Switzerland, Neurosurgical Service Recruiting
Lugano, Switzerland, 6903
Contact: Pietro Scarone, MD    0041918116455    pietro.scarone@eoc.ch   
Contact: Martina Dalolio, MD    0041918116451    martina.dalolio@eoc.ch   
Sub-Investigator: Eva Koetsier, MD         
Principal Investigator: Pietro Scarone, MD         
Sponsors and Collaborators
Neurocenter of Southern Switzerland
Maastricht University
Schulthess Klinik
Investigators
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Principal Investigator: Pietro Scarone, M.D. Neurocenter of Southern Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pietro Scarone, Staff Neurosurgeon, Principal Investigator, Neurocenter of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03969602    
Other Study ID Numbers: NSI-TD/NCH-01
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pietro Scarone, Neurocenter of Southern Switzerland:
Pain Catastrophizing
Cognitive Behavioral Therapy
Rehabilitation
Spinal disease
Spinal fusion
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis