None listed
Conditions
Brief summary
This study looks at whether people recover better after anterior-to-psoas (ATP) lumbar fusion surgery when they follow a less restrictive rehabilitation plan. Although ATP is a minimally invasive technique that may allow earlier movement and return to activity, rehabilitation advice is often still based on older, more cautious programs designed for more invasive surgery. Before surgery, participants will be randomly assigned before surgery to either a standard or an accelerated rehabilitation program. A multidisciplinary clinical team will support recovery in both groups, with wound healing and patient safety prioritised throughout. Recovery will be checked every two weeks for 12 weeks, and at 1 and 2 years after surgery using questionnaires, patient-reported outcome measures, and functional tests. The primary objective of this study is to determine whether the accelerated rehabilitation group results in equal or more patients achieving minimal clinically important differences in Oswestry Disability Index by 12 weeks post-surgery for patients undergoing ATP lumbar fusion surgery.
Interventions
This trial will investigate whether a less restrictive, accelerated rehabilitation program leads to faster and improved recovery compared with standard rehabilitation after anterior-to-psoas (ATP) lumbar fusion surgery. Participants will be randomly allocated before surgery to either a standard or accelerated rehabilitation program.
In both groups, patient/participant safety and wound healing will be prioritised throughout the study. Routine post-surgical appointments are scheduled with a Nurse
This trial will investigate whether a less restrictive, accelerated rehabilitation program leads to faster and improved recovery compared with standard rehabilitation after anterior-to-psoas (ATP) lumbar fusion surgery. Participants will be randomly allocated before surgery to either a standard or accelerated rehabilitation program. In both groups, patient/participant safety and wound healing will be prioritised throughout the study. Routine post-surgical appointments are scheduled with a Nurse Practitioner. Additionally, both groups will have their rehabilitation programs guided by healthcare professionals at Neurospine Institute, namely by Exercise Physiologists/Biokineticists (company: FitSpines). Standard post-operative rehabilitation provided by FitSpines is delivered one-on-one and tailored to each patient’s needs, abilities, and recovery progress. Care is provided by qualified Exercise Physiologists/Biokineticists and is based on the McGill method from BackFit Pro, which is based on treating the cause of the pain as opposed to just the symptoms of pain. Accordingly, the program is therefore individualised to each patient. Patients typically attend one pre-operative session for education and basic muscle-strengthening exercises, followed by a post-operative session at around 2-4 weeks to review mobility, reinforce safe movement strategies, and progress exercises as appropriate; further sessions may be offered if clinically indicated. The McGill program for spine rehabilitation generally begins with a walking program and light resistance exercises, before progressing to core and resistance work, with progression typically reviewed every two weeks to support a safe and positive recovery. Patients are usually expected to complete their prescribed exercises 3-4 times per week. Exercises may include (but are not limited to) bird dogs, planks, side planks, abdominal curl-ups, glute bridges, and clams. Thera-Band resistance exercises may also be recommended (e.g., pulling, pushing, and shoulder extension movements such as flies). Spinal hygiene education is also provided using practical movement strategies designed to reduce post-operative spinal sensitivity and minimise early rehabilitation risk (e.g. adjacent segment disease and re-herniations associated with repeated flexion). This may include (but are not limited to) instructions on coughing and sneezing, sitting with lumbar support, safe squatting to reach items from the floor, tying shoelaces, and to get in and out of bed or a car. Exercise intensity is adjusted across different levels and prescribed on a case-by-case basis according to the patient’s stage of recovery. Participants will be followed up by members of the Neurospine Institute research team on a fortnightly basis (until 12 weeks after surgery, then again at 1 and 2 years after surgery), providing regular opportunities to check progress and address any concerns.
Sponsors
Neurospine Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will only be invited to this study if they meet all of the following: -- are a patient of Neurospine Institute; -- if they are at least 18 years old at the time of surgery; -- if they are scheduled for an anterior-to-psoas (ATP) surgery (single-level operation, suplemented with pedicle screw posterior fixation) by a Neurospine Institute surgeon; -- if they provide explicit, prospective informed consent to participate in this study; -- if they are willing to be randomised prior to surgery; -- if they intend to complete all standard of care (SoC) pre- and post-surgical care appointments with health care professionals, including: > at Neurospine Institute: - with FitSpines (at 1-2 weeks pre-surgery, and 4 weeks post-surgery); - with Nurse Practitioner (at 2 weeks post-surgery); - with treating surgeon (at 12 weks post-surgery); -- if they intend to complete patient reported outcome measures (PROMs) and questionnaires, including: > at baseline (pre-surgery), 2, 4, 6, 8, 10, and 12 weeks post-surgery, and 1 and 2 years post-surgery: - EQ-5D-5L; - VAS; - ODI; - TSK-17; - FABQ; - PSEQ; - Return to Work Questionnaire; > at baseline, and 2, 4, and 12 weeks post-surgery: - 6-minute walk test; - Timed Up and Go; > at 6 and 12 weeks post-surgery: - Patient Satisfaction Questionnaire] -- if patients complete radiological imaging at >1 year post-surgery to confirm successful fusion (this imaging is performed as part of standard of care and not specifically for this trial).
Exclusion criteria
Patients will be excluded from recruitment or during the study if they do not meet all of the inclusion criteria and/any of the below: - patients who have had previous ATP lumbar fusion surgery at Neurospine Institute (as it may not be possible to completely blind patients to either the 'standard' or 'accelerated' group, as similar rehabilitation programs were likely followed for their prior procedure surgery); - patients who do not have adequate English language proficiency and who do not have access to a translator to provide informed consent; - patients with psychological complications inhibiting their participation and patients with cognitive impairment who are unable to provide informed consent. Please note: Patients will not be excluded from being invited to the study if they access additional healthcare services outside of NSI (i.e. in addition to the sessions with FitSpines). After participants have been randomised to either ‘standard’ or ‘accelerated’ rehabilitation groups, they will receive written exercises and instructions that they can share with any external healthcare provider. This will help ensure any additional care aligns with the trial rehabilitation program and does not conflict with it.
Outcome results
None listed