Low back pain (LBP) has a major impact on individual and societal level, given the resulting pain, functional disability, and socio-economic consequences. In a subgroup of patients with LBP, radicular pain is present due to nerve root involvement, and spinal surgery can be indicated. Despite the increasing number of spinal surgeries performed, the outcome is not optimal, with a substantial part of patients not returning to work at one year postoperatively. Consequently, optimizing clinical outcomes after lumbar spine surgery for radicular pain, in particular in terms of return to work, would reduce the individual and socio-economic burden of these patients. The pre-, peri- and postoperative period of lumbar spine surgery forms a window of opportunity to improve those patient outcomes thereby enhancing the value of spine care. Despite the growing interest in pre-, peri- and postoperative rehabilitation, current rehabilitation practices are highly variable.
A more structured evidence-based rehabilitation pathway for the pre-, peri, and postoperative period is available and has been implemented on a small scale (REACT study, UZ Leuven). It showed over 50% reduction in the interval to return to work, but the rehabilitation pathway may not be implementable in everyday practice on a large scale, and/or may not be cost-effective on a large scale.
Therefore, the main objective of this project is to compare a structured evidence-based rehabilitation pathway with usual, variable, rehabilitation care in patients undergoing surgery for lumbar radicular pain, in a pragmatic real-world setting on a large scale (i.e., nationwide and in all patients undergoing lumbar surgery for radicular pain).
| Title | An evidence-based Rehabilitation pathway for patients undergoing surgery for lumbar Radicular pain to promote Return to work: a cluster randomized trial comparison with usual care |
| Participants (P) | Patients aged 18-65 years with >6 weeks of lumbar radicular pain, employed or on sick leave due to spinal pathology, that are being scheduled for surgery and without malignant diseases, spinal fractures, infectious diseases, rheumato-/neurological, or neuromuscular disorders |
| Intervention (I) | A structured evidence-based rehabilitation pathway, guided by a case manager, starting preoperatively to 1 year postoperatively, including prehabilitation, perioperative rehabilitation and postoperative rehabilitation, with emphasis on fear reduction by keeping activity restrictions minimal and relevant, eliminating bracing and on active guidance to work resumption. |
| Control (C) | Usual care, i.e. usual, variable rehabilitation care, which may vary between and within hospitals and may include no rehabilitation intervention, monodisciplinary or multidisciplinary care, with highly variable advice to the patients |
| Outcome (O) | Time to return to work (defined as at least 50% return in own/equal work) after surgery |
| Trial Design | Cluster randomized controlled trial where participants are participating from the preoperative period through 12 months after surgery |
| Sample Size | 480 participants |
| Trial duration | 12 month recruitment, 15 month follow up: 34 months |
| Budget | € 1,920,000 |
| Sponsor | UZ Leuven |
| Chief Investigator | Prof Bart Depreitere |
| Number of participating sites | 15 & 1 reference centre (UZ Leuven) confirmed sites: AZ Delta Roeselaere, AZ Groeninge Kortrijk, AZ Sint-Jan Brugge, AZ Sint-Maarten Mechelen, Centre Hospitalier de Wallonie Picarde, Clinique Saint-Pierre Ottignies, Grand Hôpital de Charleroi, Jessa Ziekenhuis, UZ Brussel, UZ Leuven, ZAS Sint-Augustinus, ZOL Genk, Heilig Hart Ziekenhuis Lier, Jan Yperman, AZ Herentals |
