Early rehabilitation after lumbar spinal fusion using dialogue and graded activity
Official title: Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study
Run by Copenhagen University Hospital, Rigshospitalet · NCT07378735 · Data updated 2026-11-12
This trial tests a tailored physiotherapy package that combines conversation, education, and gradually increasing activity to help adults after lumbar spinal fusion see if they improve in activity, pain, and confidence.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2028 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07378735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with chronic low back pain scheduled for or recently undergoing lumbar spinal fusion and able to read Danish, residing in Frederiksberg or Copenhagen municipalities.
✕Probably not a fit
Patients with post-traumatic spinal issues, active infection, neoplasm, metastasis, metabolic bone disease, fractures, autoimmune conditions, cognitive impairments, or other factors that limit participation or consent may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines an early rehabilitation program for adults after lumbar spinal fusion. The program uses Socratic dialogue and graded activity, with education and individualized goals, delivered as a bio-psycho-social approach. Outcomes focus on patient-specific goals, physical activity levels, pain intensity and interference, fear of movement, and pain self-efficacy. A pilot phase with three participants precedes the main inclusion of twelve patients at Rigshospitalet in Denmark. The trial aims to determine feasibility and potential benefits within the Danish healthcare setting.
Why it matters
Potential benefit: If successful, patients may regain activity sooner and experience better pain management and confidence after lumbar fusion.
How similar studies have gone: Earlier rehabilitation approaches incorporating cognitive-behavioral elements have shown benefits for post-spinal fusion rehab, supporting potential usefulness of this method.
Who can join: the full rules
Show full inclusion / exclusion criteria
The investigators will in total include 12 patients undergoing an LSF from the Centre for Rheumatology and Spine Diseases at Rigshospitalet, Denmark. Before inclusion, a pilot of three participants will be performed. Inclusion Criteria for all included: * ≥ 18 years of age * Low back pain (LBP) \> 3 months * Read and understand the Danish language * The participants should be a part of Frederiksberg Municipality and Copenhagen Municipality (in Denmark) Exclusion Criteria: * Post-traumatic vertebral compression/deformity * Patients with the following conditions (infection, neoplasm, metastasis, metabolic bone disease, fractures or other known autoimmune arthropathies) * Patients with patient-related circumstances (physical or mental status) that impede their ability to give informed consent and adhere to the study program (e.g., dementia, developmental disorders, or substance-induced cognitive impairment) * Other special conditions, where the patient is judged by the surgeon as inappropriate to participate
Where it's running
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Department of Occupational Therapy and Physiotherapy
Glostrup Municipality, Denmark Recruiting
Study contacts
- Study coordinator: Heidi Tegner, Post doc
- Email: heidi.tegner@regionh.dk
- Phone: 0045 38633092
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.