NCT06709391 Fusion or Not - a Study on Low Back Pain
| NCT ID | NCT06709391 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Low Back Pain, Mechanical |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-02-01 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 studies comparing fusion surgery for low back pain with non-surgical treatments, but these have showed different results. The effect of fusion surgery on low back pain is therefore uncertain. Surgical treatments brings with it a clear placebo effect. Other studies on pain in other parts of musculoskeletal system than the back has not been able to show that a surgical treatment is always better than placebo surgery. This has called into question the effect of surgery on many painful conditions of the musculoskeletal system. No placebo-controlled surgical studies have been done on fusion surgery for low back pain. A placebo surgical controlled study is the only way to ascertain whether fusion surgery is the right treatment for low back pain. In this study, 90 individuals will undergo surgical treatment for low back pain. After surgical exposure, the surgeon will be informed whether fusion surgery should be performed or not. Half of the patients will undergo a fusion procedure with implants and the other half will not undergo the fusion procedure and will not receive implants. Treatment randomization will be performed during surgery, and the individuals undergoing treatment and the staff taking care of the individual after surgery will be blinded for treatment allocation during 6 months. That means that the individuals participating in the study and the staff who meet the individuals after surgery won't know if the individual had fusion surgery or no fusion surgery until after the 6 month follow-up. The most important outcome of the study is the result of a questionnaire-based measure of back function answered by the participating individuals.
Eligibility 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)
Contact & Investigator
Paul Gerdhem, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT06709391 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Low Back Pain, Mechanical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06709391 currently recruiting?
Yes, NCT06709391 is actively recruiting participants. Contact the research team at paul.gerdhem@uu.se for enrollment information.
Where is the NCT06709391 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Stockholm, Sweden, Uppsala, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT06709391 clinical trial?
NCT06709391 is sponsored by Uppsala University. The principal investigator is Paul Gerdhem, MD, PhD at Uppsala University. The trial plans to enroll 90 participants.