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Fibromyalgia study links immune system to pain

NCT ID NCT07346950

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 164 women with and without fibromyalgia to see if certain autoantibodies are linked to more severe symptoms. Researchers compared patients with high and low antibody levels, and healthy controls, using questionnaires, blood tests, skin biopsies, and brain scans. The goal was to better understand how the immune system and nervous system interact in fibromyalgia.

What this could mean

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

What this could lead to
If successful, this could help explain the biological causes of fibromyalgia and point toward new treatment targets.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not lead to direct therapies.

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.

Participants

164 people

The number who actually took part.

Started

Nov 2022

Finished

Dec 2025

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.

Who is studied

In total, 80 subjects with fibromyalgia (FM) and 42 healthy controls (HC) will be included. Subjects predominantly live in Uppsala County, Sweden, which has a population of approximately 400,000 inhabitants. If we consider the prevalence of FM to be 2%, that translates to \~8,000 patients. Since the study is on female subjects, and about 70% of FM patients are female, that leaves about 5,600 patients in the pool. The sample size has been determined based on previous research where a group size of 40 subjects was deemed sizeable enough to identify meaningful differences in expression of proteins. As we are interested in two groups of FM patients, i.e., those with high and low levels of autoreactive autoantibodies, and we expect about 50% of participants with FM to have high titers, we will require about 80 participants in the FM group. For the NINS cohort, the biobank of the neurological clinic at Uppsala University Hospital will be utilized to find appropriate CSF controls.

Ages

20 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female sex * Age 20-70 * Fibromyalgia according to the ACR 1990+2016 criteria for the FM cohort. Exclusion Criteria: * Reported BMI \> 35 during screening over a phone call. * Other dominant chronic pain states. * Autoimmune diseases (exception: primary hypothyroidism). * Serious somatic or psychiatric disease. * Current pregnancy. * Non-fluency in Swedish. * For HC: history of chronic pain or current pain exceeding 20 on a 0-100 scale or having received an FM diagnosis. * For NINS: having received an FM diagnosis.

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Conditions

The condition(s) this trial relates to.

fibromyalgia Neuroinflammatory Diseases

As listed by the trial registrant

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

Fibromyalgia

Contacts and locations

Locations

  • Uppsala University Hospital

    Uppsala, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.