Comparing fusion surgery and non-surgical treatment for low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of fusion surgery versus non-surgical treatments for patients suffering from chronic low back pain due to degenerative disc disease. Participants will be randomly assigned to receive either fusion surgery or a structured non-surgical treatment approach after experiencing persistent pain for over a year. The study aims to clarify the benefits and risks associated with fusion surgery, which remains a common yet controversial treatment option. By including an observational group that does not receive any specific treatment, the trial seeks to provide more definitive insights into the management of low back pain.

Why it matters

Who can join: the full rules

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)

Where it's running

• Sahlgrenska university hospital
  Gothenburg, Sweden Recruiting
• Ryggkirurgiskt centrum
  Stockholm, Sweden Recruiting
• Uppsala University
  Uppsala, Sweden Recruiting
• Aleris Elisabetsjukhuset
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Paul Gerdhem, MD, PhD — Uppsala University
• Study coordinator: Paul Gerdhem, MD, PhD
• Email: paul.gerdhem@uu.se
• Phone: +46(0)186110000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.