Comparing fusion surgery and non-surgical treatment for low back pain
Fusion or Not- a Randomized Controlled Study on Low Back Pain
This study tests whether fusion surgery or a structured non-surgical treatment works better for people with chronic low back pain from degenerative disc disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT06709391 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of fusion surgery versus non-surgical treatments for patients suffering from chronic low back pain due to degenerative disc disease. Participants will be randomly assigned to receive either fusion surgery or a structured non-surgical treatment approach after experiencing persistent pain for over a year. The study aims to clarify the benefits and risks associated with fusion surgery, which remains a common yet controversial treatment option. By including an observational group that does not receive any specific treatment, the trial seeks to provide more definitive insights into the management of low back pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-65 with chronic low back pain lasting over 12 months, who have not responded to non-surgical treatments.
Not a fit: Patients with severe osteoporosis, significant cardiovascular issues, or those who have previously undergone spine surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the effectiveness of fusion surgery for low back pain, potentially improving treatment outcomes for patients.
How similar studies have performed: Previous studies comparing fusion surgery to non-surgical treatments have shown mixed results, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Axial, mechanical, stabbing pain localized to the lower lumbar spine, persisting for at least 12 months, in which non-surgical treatments have been unsuccessful * A perceived improvement of back muscle strength after structured physical exercise, but severe, quality-of-life-reducing pain persists * No symptoms or clinical signs of radiculopathy or neurogenic claudication (spinal stenosis) * Numeric rating scale back pain of at least 5 (on a 0-10 (worst) scale) * Oswestry Disability index of at least 35 (on a 0-100 (worst) scale) * MRI-confirmed degenerative disc disease at L4/L5 and/or L5/S1. * 25-65 years of age * American Society of Anesthesiologists (ASA) classification 1 or 2. * No previous spine surgery, except for previous discectomy without fusion on the symptomatic level * Written informed consent Exclusion Criteria: * Inability to give informed consent * Unable to understand Swedish * Unable to attend follow-up visits * Severe osteoporosis making the patient unfit for surgery * Severe cardiovascular, pulmonary or other chronic disease making the patient unfit for surgery * Isthmic or degenerative spondylolisthesis, grade 2 or larger * New or old fractures * Spondylodiscitis * Anchylosing spondylitis or other inflammatory process in the spine * Active neoplasm * Symptoms and clinical signs of nerve root compression or neurogenic claudication requiring decompressive surgery * Prior lumbar spine surgery (previous discectomy without fusion is not an exclusion criteria)
Where this trial is running
Gothenburg and 3 other locations
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
- Ryggkirurgiskt centrum — Stockholm, Sweden (Recruiting)
- Uppsala University — Uppsala, Sweden (Recruiting)
- Aleris Elisabetsjukhuset — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Paul Gerdhem, MD, PhD — Uppsala University
- Study coordinator: Paul Gerdhem, MD, PhD
- Email: paul.gerdhem@uu.se
- Phone: +46(0)186110000
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.