Clinical trial NCT03969602: Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lumbar Spondylolisthesis
Lumbar Instability
Spinal Disease
Keywords: Pain Catastrophizing
Cognitive Behavioral Therapy
Rehabilitation
Spinal disease
Spinal fusion
Lead sponsor: Neurocenter of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Schulthess Klinik
First posted: 2019-05-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The incidence of moderate to severe chronic postsurgical pain (CPSP) at 12 months after surgery is circa 12% in Europe, depending in part upon the surgical procedure. Worldwide, more than 230 million people undergo major surgery every year; the global annual cost of new cases of CPSP is in the hundreds of billions of dollars. The response to this costly tragedy has been unacceptably slow.

Perioperative protocols have historically not incorporated routine screening for patients at-risk for post-surgery persistent pain or compromised function. However, early detection and management of patients at high risk for CPSP may modify the postsurgical pain trajectory and reduce the incidence of CPSP.

In particular, persistent pain and disability after spinal surgery poses a large problem. Around 20% of the patients have persistent or recurrent pain in the back or limbs after surgical interventions for spinal disease. Several risk factors for such unfavorable outcomes have been identified, among which psychological factors. The most robust psychological predictors of high levels of acute postsurgical pain and of persistent pain in the back or limbs after spinal surgery are high levels of preoperative anxiety and pain catastrophizing.

Psychological variables are modifiable and could be target for intervention. Cognitive Behavioral Therapy (CBT) is the leading psychological treatment for chronic pain. CBT aims to reduce maladaptive cognitions and behaviors and replace these with more adaptive ones. CBT has been shown to reduce anxiety and catastrophizing and to increase self-efficacy and feelings of control beliefs and through this lowers pain-related disability and pain interference (including sleep problems and depression).

This study is a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing lumbar spinal fusion surgery outcome between 2 groups with high pain catastrophizing, 1 that receives perioperative CBT plus usual care (experimental group) and 1 that receives usual care (control group). To minimize expectation bias in patients, an educational intervention is added in the control group.

Patients will be enrolled in the Department of Neurosurgery at the Neurocenter of Southern Switzerland, Lugano Regional Hospital and the department of Neurosurgery of Zuyderland Medical Center, Heerlen, The Netherlands.

Patients with as score of ≥ 24 on the PCS will be eligible to be randomized to perioperative CBT plus usual care or education plus usual care.

Data collection sessions will occur for each patient randomized, at baseline, at 8 weeks, and at 6 and 12 months following surgery. A third, non-randomized group is also included, consisting of low catastrophizing patients. These patients will not undergo any additional intervention besides usual care, but will undergo the same data-collection as the high catastrophizing randomized groups. This offers the possibility to examine whether CBT can reduce the negative effects of catastrophizing on outcome to the level of improvement one would expect in non-catastrophizing patients. Staff blinded to group assignment will contact patients by phone at circa one week before data collection time points to remind them to fill in the questionnaires.

Primary hypothesis of the investigators is that patients randomized to the CBT group show a greater improvement on the Core Outcome Measures Index (COMI) at 12 months post-surgery compared to patients randomized to the control group.

Secondary hypotheses are that patients randomized to the CBT group show a larger reduction in disability (ODI), leg/back pain (NRS), depression and pain catastrophizing (PCS) at 12 months post-surgery compared to patients randomized to the control group. Moreover, patients in the CBT group report higher global impression of chance, less reliance on analgesics and better employment status compared to patients in the control group. Finally, the investigators hypothesize that the high catastrophizing group receiving the control intervention will have worse outcomes on all measures compared to the low catastrophizing group receiving standard care, whereas the high catastrophizing group receiving the CBT intervention will have comparable outcomes as the low catastrophizing group.

All included patients will be assessed before surgery for the outcomes of interest. Patients assigned to the CBT intervention condition will attend six individual 60-min CBT sessions (2 before and 4 after surgery). Patients randomized to the education condition will receive six session of biomedical education and an exercise program. Non-randomized low catastrophizing patients do not receive an additional intervention. All patients will receive care that they would have routinely received had they not been entered in the study (i.e. standard postoperative physical therapy). The three groups of patients will undergo the same data collection procedures.

The primary outcome is the difference in the COMI between the study groups, 12 months after surgery. A difference of two points is considered clinically meaningful \[44\]. With an assumed SD of 2.5, the effect size of this difference, quantified as Cohen's d is 0.80. Inclusion of 42 patients per intervention group will yield a power of 0.95 at a type-I error rate of 0.05. In addition, 42 patients with low pain catastrophizing scores will undergo the same assessments, but not receive any intervention besides care as usual. Taking into account a drop-out rate of 15%, 150 patients will be included in total.

Baseline patient characteristics will be stratified by group and presented as mean and standard deviation (SD), median and first and third quartile, and count and percentage, as appropriate. Differences in baseline characteristics between randomized groups will not be statistically tested, whereas differences with the separate control cohort will be tested using the independent-samples t-test for continuous variables, and Pearson's chi-square test for categorical variables. In case of expected cell counts of less than 5, Fisher's Exact test will be used instead.

All patients randomized (i.e. those with a PCS score \> 24) will be analyzed in an intention-to-treat analysis. To test for a difference between the CBT and control group in the COMI at 12 months, linear regression will be used, with correction for baseline COMI and center. In addition, the difference in the trajectory of COMI over time will be assessed by means of linear mixed-effects regression, taking all follow-up measurements into account. Adjustment for center, type of surgery, age and gender will be made and, if necessary, for other prognostic variables significantly associated with the outcome (i.e., acute postoperative pain intensity, preoperative depression, preoperative surgical fear, length of current sick leave, pain duration). Stepwise backward elimination using the Wald test will be used to select prognostic variables significantly associated with the outcome. Any control variables that are incomplete will be imputed if the proportion of incomplete patients exceeds 0.05. Investigators will use multiple imputation with fully conditional specification with the number of imputations set to the percentage of incomplete patients. Predictive mean matching will be used to draw values to be imputed. Secondary outcome variables will be analyzed similar to the primary outcome. For these, logistic regression analysis adjusted for center will be used to test for differences in proportions at 12 months postoperatively.

Exploratory, investigators will compare the outcomes of the patients in the two intervention groups with the outcomes of patients with low pain catastrophizing scores (i.e. those with a PCS score \< 24) undergoing care as usual. Linear mixed-effects regression for the three groups will be performed with primary and secondary outcomes at the three postoperative assessment periods and controlling for preoperative values. This analysis will indicate whether high catastrophizing patients follow a similar trajectory of pain and functioning after spinal fusion surgery compared non-catastrophizing patients.

Eligibility 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

Primary outcomes:
measure: COMI (Core Outcome Measure Index)
timeFrame: 12 months post surgery
Secondary outcomes:
measure: NRS Pain (The Numeric Rating Scale for Pain)
timeFrame: 4 days, 8 weeks, 6 and 12 months post surgery
measure: ODI (Oswestry Disability Index)
timeFrame: 8 weeks, 6 and 12 months post surgery
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) for depression
timeFrame: 8 weeks, 6 and 12 months post surgery
measure: PGIC (Patient's global impression of change)
timeFrame: 8 weeks, 6 and 12 months post surgery
measure: PCS (Pain catastrophizing)
timeFrame: 8 weeks, 6 and 12 months post surgery
measure: EQ-5D-5L (The 5-level EuroQol 5 Dimensions) for quality of life
timeFrame: 8 weeks, 6 and 12 months post surgery
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland, Neurosurgical Service
Study officials:
affiliation: Neurocenter of Southern Switzerland
name: Pietro Scarone, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.