Placebo surgery to reveal truth about back pain operations

NCT ID NCT06709391

Knowledge-focused Sponsor: Uppsala University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 4 times

Summary

This study aims to find out if spinal fusion surgery truly helps people with long-term low back pain. Ninety adults with severe, persistent pain will undergo surgery, but half will receive a placebo procedure without fusion. Neither the patients nor their care team will know which group they are in for six months. The main goal is to measure changes in back function using a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: fusion surgery (spinal fusion with implants)
What this could lead to: If fusion surgery proves better than placebo, it could confirm this procedure as an effective treatment for chronic low back pain.
What could go wrong: This is a small, early-stage trial with only 90 participants. Surgery carries risks like infection or nerve damage, and the placebo effect may be strong.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Degenerative disc disease lumbar are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder Low Back Pain lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease lumbar Low back pain, mechanical

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Placebo surgery to reveal truth about back pain operations

What the study statuses mean