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

NCT03969602 | Unknown DMC

• 1 other identifier: NSI-TD/NCH-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Lumbar Instability; Spinal Disease

Keywords

Pain Catastrophizing; Cognitive Behavioral Therapy; Rehabilitation; Spinal disease; Spinal fusion

Outcome Measures

Primary Outcomes (1)

• COMI (Core Outcome Measure Index)

  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.

  12 months post surgery

Secondary Outcomes (6)

• NRS Pain (The Numeric Rating Scale for Pain)

  4 days, 8 weeks, 6 and 12 months post surgery

• ODI (Oswestry Disability Index)

  8 weeks, 6 and 12 months post surgery

• PROMIS (Patient-Reported Outcomes Measurement Information System) for depression

  8 weeks, 6 and 12 months post surgery

• PGIC (Patient's global impression of change)

  8 weeks, 6 and 12 months post surgery

• PCS (Pain catastrophizing)

  8 weeks, 6 and 12 months post surgery

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Observational Group (low catastrophizing)

NO INTERVENTION

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.

Interventions

Cognitive-behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

Experimental Group

Biomedical and surgery-specific education OTHER

Biomedical and surgery-specific education preoperatively and an exercise manual postoperatively.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• an opioid intrathecal pump
• prisoners

Sponsors & Collaborators

• Neurocenter of Southern Switzerland: lead
• Maastricht University: collaborator
• Schulthess Klinik: collaborator

Study Sites (1)

Neurocenter of Southern Switzerland, Neurosurgical Service

Lugano, 6903, Switzerland

RECRUITING

Related Publications (1)

• Scarone P, Smeets AYJM, van Kuijk SMJ, van Santbrink H, Peters M, Koetsier E. A randomized controlled TRIal of cognitive BEhavioral therapy for high Catastrophizing in patients undergoing lumbar fusion surgery: the TRIBECA study. BMC Musculoskelet Disord. 2020 Dec 4;21(1):810. doi: 10.1186/s12891-020-03826-w.

  PMID: 33276768 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Spinal Diseases

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pietro Scarone, M.D.

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Scarone, M.D.

CONTACT

+41918116455; pietro.scarone@eoc.ch

Eva Koetsier, M.D.

CONTACT

+41918117595; eva.koetsier@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neurosurgeon, Principal Investigator

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: January 23, 2020
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)