Radar des Essais Cliniques

This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.

The Get Back rehabilitation program has been developed using the Medical Research Councils (MRC) framework. A feasibility study (NCT05806593) has been completed involving 29 patients (mean age 67) who underwent surgery for LSS. The Get Back intervention (completely digital i.e. assessments and rehabilitation) was shown to be feasible and resulted in clinically significant improvements in daily steps at 12 weeks' post-surgery.

To evaluate the effectiveness and process of Get Back a multicenter randomized controlled trial including three sub-studies will be conducted. The specific research questions we aim to investigate in this RCT are:

1. if Get Back is more effective than standard rehabilitation in increasing daily steps (primary outcome) and physical activity behavior, disability, or pain-related factors (secondary outcomes) after surgery for LSS
2. if Get Back is more cost effective than standard rehabilitation after surgery for LSS
3. how baseline values (psychological factors, physical capacity and physical activity) predict changes in daily steps after surgery for LSS
4. how participants' experiences contribute to an enhanced understanding of what impact the intervention content had on their physical activity behavior.

Patients will be recruited from four clinical study sites (two private spine clinics and two hospitals). All patients undergo a clinical examination by an orthopedic surgeon as part of standard preoperative care. If a surgical decision is made and the patient is placed on the waiting list, a local recruiter at each site will hand out written study information to the patients meeting inclusion criteria and ask if a physical therapist from the study can make contact to provide further information about the study and ask for participation. As the intervention is fully digital, the patient information in written will also be sent to the patient digitally.

At baseline (approx. 2 weeks pre-surgery), participants meet with an assessor (physical therapist) via a digital care platform for collection of demographic data, personal goals, and to conduct physical capacity tests. Questionnaires are sent out through a digital application and patients wear an accelerometer for 7 days sent out by mail. Outcome variables are described more in detail under the heading Outcome Measures in the trial registration. The follow-ups are scheduled at 6 weeks, 3 months, 6 months, and 1-year post-surgery. Accelerometry and questionnaires will be collected at each follow-up, whereas physical capacity tests will be conducted at 3 and 12 months post-surgery. Clinical data such as type of surgery, complications, discharge destination will be collected from the patients' medical records at 3 months post-surgery.

After baseline assessments, patients are randomly assigned (1:1) to either control or intervention group. The randomization will be based on a computerized random list converted to concealed envelopes. The assessor will be blinded to group allocation.

Participants in the intervention group (Get Back, n=126) will have one pre-surgery video session with a physical therapist, followed by up to five core video sessions and five booster telephone sessions over 13 weeks. Session frequency is decided collaboratively, based on person-centered care. The intervention includes three components: graded physical activity, addressing fear avoidance beliefs, and promoting behavior change. A person-centered health plan is created at the first session, based on the patient's story and baseline assessment. The plan includes personalized activity goals, monitored using a weekly physical activity diary to track steps, barriers, and progress. A sub-sample of the intervention group, approximately 15-20 participants, will be interviewed regarding their experiences of the intervention and intervention content at 3 months post-surgery using a semi-structured interview guide.

Participants in the control group (n=126) will follow standard rehabilitation (physical therapy as provided at each site). Data on the frequency and content of rehabilitating sessions during the study will be collected as a control variable at each follow-up assessment.