Actively Recruiting
Fusion or Not- a Randomized Controlled Study on Low Back Pain
Led by Uppsala University · Updated on 2025-09-16
90
Participants Needed
4
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
U
Uppsala University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic low back pain is a common cause of disability and reduced quality of life, affecting up to 80% of people at some point. When pain lasts over a year and does not improve with painkillers or physical therapy, surgery may be considered. This trial investigates whether fusion surgery, which stabilizes parts of the spine, is more effective than surgery without fusion for treating low back pain. The study aims to clarify the true benefit of fusion surgery, considering previous research has shown uncertain results and a possible placebo effect from surgery itself. In this randomized trial, 90 adults aged 25 to 65 with long-lasting mechanical low back pain and confirmed disc degeneration will undergo surgery. During the operation, patients will be randomly assigned to receive either fusion surgery with implants or surgery without fusion and no implants. Neither patients nor the post-surgery care team will know which treatment was given until after six months. The fusion surgery involves placing screws and rods to stabilize the spine, while the non-fusion surgery includes similar surgical exposure without implant placement. Participants will be evaluated before surgery and followed up at 3 months, 6 months, 1 year, 2 years, and 5 years. Assessments include questionnaires on back function and pain, physical tests, imaging, and quality of life measures. The main outcome is the Oswestry Disability Index score at 6 months, measuring the impact of back pain on daily activities. Safety and complications will be monitored, and data will be collected in a spine surgery registry. Participants can withdraw anytime without affecting their care, and results will help determine the true value of fusion surgery for low back pain.
CONDITIONS
Brief Title
Fusion or Not - a Study on Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 25 to 65 years
- Axial, mechanical, stabbing pain localized to the lower lumbar spine lasting at least 12 months
- Non-surgical treatments have been unsuccessful
- Perceived improvement of back muscle strength after structured physical exercise but persistent severe pain
- No symptoms or signs of radiculopathy or neurogenic claudication
- Back pain score of at least 5 on a 0-10 scale
- Oswestry Disability Index score of at least 35 on a 0-100 scale
- MRI-confirmed degenerative disc disease at L4/L5 and/or L5/S1
- American Society of Anesthesiologists (ASA) classification 1 or 2
- No previous spine surgery except previous discectomy without fusion on the symptomatic level
- Written informed consent
You will not qualify if you...
- 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
- Ankylosing spondylitis or other inflammatory spine conditions
- Active neoplasm
- Symptoms and signs of nerve root compression or neurogenic claudication requiring decompressive surgery
- Prior lumbar spine surgery other than previous discectomy without fusion at the symptomatic level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay during surgery and immediate recovery
Participants undergo either fusion surgery or non-fusion surgery under anesthesia. The surgical procedure includes identification of the surgical area with intraoperative imaging, dissection, and then randomization to either fusion with implants or non-fusion without implants. Post-operative care follows standardized protocols for lumbar fusion surgery. No post-operative radiographs are taken until after the 6-month follow-up. Patients and hospital staff except the surgical team remain blinded until 6 months.
1 surgical hospital stay (inpatient)
Duration - Up to 5 years
Participants are followed with assessments at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery to monitor outcomes including disability, pain, physical function, imaging, and complications. Participants and outcome assessors remain blinded until the 6-month follow-up, after which treatment allocation is revealed.
Follow-up visits at 3 months, 6 months, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 4 locations
1
Sahlgrenska university hospital
Gothenburg, Sweden
Actively Recruiting
2
Ryggkirurgiskt centrum
Stockholm, Sweden, 11433
Actively Recruiting
3
Uppsala University
Uppsala, Sweden, 75185
Actively Recruiting
4
Aleris Elisabetsjukhuset
Uppsala, Sweden
Actively Recruiting
Research Team
P
Paul Gerdhem, MD, PhD
C
Christian Carrwik, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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