Could shedding pounds be the key to silencing chronic back pain?

NCT ID NCT04824248

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether adding a behavioral weight reduction program to standard rehabilitation—which includes pain education and targeted exercise—can better ease chronic low back pain in overweight or obese adults. Participants are randomly assigned to receive either the combined program or rehabilitation alone over 10 weeks, with both delivered through a mix of online materials and in-person sessions. The main focus is on pain intensity, with secondary measures looking at body composition, physical activity, diet, and daily function.

What this could mean

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

Active substance
A behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy
What this could lead to
If effective, this combined approach could offer a more powerful, non-drug strategy for reducing chronic back pain in people who are overweight.
What could go wrong
The trial is relatively small and early, and the added benefit of weight loss on pain may be modest or difficult to separate from the effects of exercise and education alone.

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 84 people

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

Started

May 2025

Expected to finish

Dec 2027

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

18 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: * Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain * Non-specific low back pain for at least 3 months' duration * Currently seeking care for low back pain * Native Dutch speaker * Access to internet and computer/tablet/smartphone Exclusion Criteria: * Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale * Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy) * Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases) * BMI ≥ 40 kg/m2 * Being pregnant or given birth in the preceding year * Currently receiving dietary or exercise interventions

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Conditions

The condition(s) this trial relates to.

agnosia Chronic Pain Obesity obesity disorder Overweight Weight Loss

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Rotterdam University of Applied Sciences

    RECRUITING

    Rotterdam, Netherlands

  • Vrije Universiteit Brussel

    RECRUITING

    Brussels, Belgium

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