Digital rehabilitation program for patients after spinal stenosis surgery
Get Back, A Digital Person-Centered Rehabilitation Program to Increase Physical Activity After Lumbar Spinal Stenosis Surgery - a Randomized Controlled Trial
This study tests if a digital rehab program can help people recover better after spinal stenosis surgery compared to regular rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sophiahemmet University Academic / other |
| Locations | 4 sites (Stockholm and 3 other locations) |
| Trial ID | NCT06935201 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Get Back digital rehabilitation program compared to standard rehabilitation for patients undergoing surgery for lumbar spinal stenosis. The program focuses on increasing daily physical activity, managing fear and avoidance behaviors, and employing behavior change techniques tailored to individual needs. It is designed to address the common issue of post-surgery inactivity among patients, which can lead to worsened health outcomes. The trial will include multiple centers and aims to assess not only the effectiveness of the intervention but also its cost-effectiveness and the factors influencing patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for decompression surgery due to central lumbar spinal stenosis.
Not a fit: Patients with malignancies, severe movement dysfunction, unstable heart conditions, or those who do not understand Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical activity levels and overall quality of life for patients recovering from spinal stenosis surgery.
How similar studies have performed: Previous pilot studies have shown promising results for similar digital rehabilitation approaches, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients planned for decompression surgery due to central lumbar spinal stenosis Exclusion Criteria: * Patients with malignancy under treatment or with metastases; * History of neurological or other disorders resulting in severe movement dysfunction; * Untreated or instable heart conditions that prohibits physical tests; * Poor understanding of Swedish.
Where this trial is running
Stockholm and 3 other locations
- Ryggkirurgiskt centrum Stockholm — Stockholm, Sweden (Recruiting)
- Södersjukhuset — Stockholm, Sweden (Recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
- Capio Spine Center Göteborg — Västra Frölunda, Sweden (Recruiting)
Study contacts
- Principal investigator: Mari K Lundberg — Sophiahemmet University/Sophiahemmet Högskola
- Study coordinator: Mari K Lundberg
- Email: mari.lundberg@shh.se
- Phone: +46 8-406 20 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.