Fusion or Not- a Randomized Controlled Study on Low Back Pain

Launched by UPPSALA UNIVERSITY · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Fusion or Not," is studying the effects of fusion surgery for people suffering from long-term low back pain. Low back pain is a common issue, affecting 8 out of 10 people at some point in their lives, and for some, it can lead to ongoing problems that significantly impact daily life. The trial aims to find out if fusion surgery, which involves joining two or more bones in the spine, is more effective than not performing the surgery when other treatments have failed.

To participate in this study, individuals must be between 25 to 65 years old and have experienced low back pain for at least a year despite trying other treatments. They should have certain types of spinal issues confirmed by MRI scans. Participants will undergo surgery where the decision to perform fusion or not will be made during the procedure, without them knowing which treatment they received for six months. The main goal is to assess the improvement in back function through questionnaires. This study is important because it will help determine whether fusion surgery is a beneficial treatment for low back pain or if other options should be explored.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Low back pain for at least 12 months, in which non-surgical treatments have been unsuccessful
• • History and clinical signs indicating low back pain without signs and symptoms of radiculopathy or vertebral 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)
• • One or two level symptomatic degenerative disc disease at level L4/L5 or L5/S1.
• • MRI-findings indicating disc degeneration of one or two lumbar segments (L4/L5 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 lumbar spinal stenosis (requiring decompressive surgery)
• • Prior lumbar spine surgery (previous discectomy without fusion is not an exclusion criteria)