Fusion or Not - a Study on Low Back Pain
Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain. Low back pain affects as many as 8 out of 10 individuals at some point in life. In most people it is quickly transient with little, or only short-term, impact on function and
| Condition(s) | Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain. Low back pain affects as many as 8 out of 10 individuals at some point in life. In most people it is quickly transient with little, or only short-term, impact on function and quality of life. In some individuals, the problems can become long-lasting and significantly impair the quality of life. When analgesic and physiotherapeutic treatment have been tried and the problems are still not manageable, and have lasted more than a year, surgical treatment consisting of fusion surgery of the painful part of the spine may come in question. In Sweden, approximately 600 fusion surgeries are performed annually for low back pain. There are a few randomized s |
| Who can participate | 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 sympto |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Lead sponsor | Uppsala University |
| Locations | Gothenburg, Sweden; Stockholm, Sweden; Uppsala, Sweden; Uppsala, Sweden |
| Start date | 2025-02-01 |
| NCT ID | NCT06709391 |
| Official listing | https://clinicaltrials.gov/study/NCT06709391 |