BridgeMD
New treatment option for Low Back Pain, Mechanical
Official title Fusion or Not - a Study on Low Back Pain
ClinicalTrials.gov ID: NCT06709391
What this study is testing
- What it's testing
- Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain.
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- Axial, mechanical, stabbing pain localized to the lower lumbar spine, persisting for at least 12 months, in which non-surgical treatments have been...
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.