Fusion or Not - a Study on Low Back Pain
- NCT ID
- NCT06709391
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- Uppsala University
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 90 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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)
Study locations
4 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Sweden
Sample of listed locations
- Sahlgrenska university hospital — Gothenburg, Sweden — Site recruitment status not specified in the registry data
- Ryggkirurgiskt centrum — Stockholm, 11433, Sweden — Site recruitment status not specified in the registry data
- Aleris Elisabetsjukhuset — Uppsala, Sweden — Site recruitment status not specified in the registry data
- Uppsala University — Uppsala, 75185, Sweden — Site recruitment status not specified in the registry data
Study details
- Start date
- February 1, 2025
- Primary completion date
- December 1, 2030
- First posted
- November 29, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06709391
- Registry last updated
- September 8, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06709391 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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