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Fusion or Not - a Study on Low Back Pain

RecruitingNAAges 25 Years - 65 YearsAllUppsala University
NCT06709391 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sh

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📋 Eligibility rules (as published)
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)
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What it tests

  • Fusion surgery
  • Non-fusion surgery
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Where

4 sites
Sahlgrenska university hospital
Gothenburg, Sweden
Ryggkirurgiskt centrum
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
Aleris Elisabetsjukhuset
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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