Use of the PREPARE (PREhabilitation, Physical Activity and exeRcisE) program to improve outcomes after lumbar fusion surgery for severe low back pain: a study protocol of a person-centred randomised controlled trial

Abstract

BackgroundFollowing lumbar fusion surgery, a successful outcome is empirically linked to effective rehabilitation. While rehabilitation is typically postoperative, the phase before surgery – termed prehabilitation – is reportedly an ideal time to prepare the patient. There are presently no guidelines for prehabilitation before lumbar fusion surgery. Physical activity has well-known health benefits, and staying physically active despite pain is a major principle in non-pharmacological chronic low back pain treatment. Psychological factors such as fear of movement, pain catastrophizing and low self-efficacy are known to be barriers to staying active. No studies have investigated prehabilitation protocols that promote physical activity and target psychological risk factors before lumbar fusion surgery. The aim of our proposed randomised controlled trial is to investigate whether patients who undergo lumbar fusion surgery for degenerative disc disease experience better functioning with a physiotherapeutic prehabilitation program (PREPARE) based on a cognitive behavioural approach compared to conventional care.Methods/DesignWe will recruit 110 patients between 18–70 years of age with degenerative disc disease who are waiting for lumbar fusion surgery. These patients will be randomly assigned to receive either PREPARE or conventional care. PREPARE uses a person-centred perspective and focuses on promoting physical activity and targeting psychological risk factors before surgery. The primary outcome will be disability measured using the Oswestry Disability Index 2.0. Secondary outcomes will include functioning (patient-reported and performance-based), physical activity (accelerometer), health-related quality of life, back and leg pain intensity, pain catastrophizing, kinesiophobia, self-efficacy, depression, anxiety, satisfaction with treatment results and health economic factors. Data will be collected at baseline (preoperatively) after the intervention (preoperatively), 3 and 8 weeks, 3, 6, 12, 24 and 60 months postoperatively.DiscussionWe hypothesise that the focus on promoting physical activity and targeting psychological risk factors before surgery will decrease disability and help the patients to be more active despite pain both before and after surgery. We will use a combination of outcome measures both patient-reported and performance-based, as well as accelerometer data. This will provide a more comprehensive picture of the patient’s functioning than just patient-reported outcomes alone.Trial registrationCurrent Controlled Trials ISCRTN17115599, Retrospectively Registered 18 May 2015.

Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers

“…One study has examined delivery of a cognitive-behavioral intervention in adults before surgery, finding no improvement in 12 month outcomes 24 . Trials are currently underway examining the effect of preoperative delivery of cognitive-behavioral therapy before major spine surgery on disability and pain in adults 13 . The findings of the present study can further inform intervention development and extend existing interventions with the aim of improving recovery at long-term follow-up for older children and adolescents undergoing major surgeries.…”

Developing an evidence-based prehabilitation programme designed to improve functional outcomes after lumbar fusion surgery - A feasibility study using the Medical Research Council framework

“…This study aimed to explain the process of developing a complex intervention and the steps taken along the way to improve the quality of an intervention (PREPARE) to be studied in future RCT [17]. We found that the first pilot intervention, the discussion in the research group and the SSRD study was invaluable in the contextual adaptation of the intervention for a subsequent RCT.…”

“…This project (including all phases below) concerns patients diagnosed with degenerative disc diseases (DDD) by an orthopaedic surgeon and who were on the waiting list for lumbar fusion surgery for one to three segments of the lumbar spine [17].…”

“…Based on the results of the SSRD study, the contextual adjustments mentioned above were made to the PREPARE programme. Finally, the PREPARE programme was written up in the form of a published study protocol ( Figure 9) [17].…”

“…These are: number of interacting components within the experimental and control interventions; number and difficulty of behaviours required by those delivering or receiving the intervention; number of groups or organisational levels targeted by the intervention; number and variability of outcomes and degree of flexibility; and determining whether tailoring the intervention is permitted. We, therefore, decided to apply the Medical Research Council (MRC) framework approach for developing a complex intervention [15] in the development of our planned RCT [17].…”