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Could a 12-Week lifestyle program ease chronic pain without drugs?

NCT ID NCT07693062

Symptom relief Sponsor: Prefectural University of Hiroshima Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This pilot study tests a 12-week program that combines a pain education booklet with exercise therapy for adults with chronic nociplastic pain. The program covers pain science, goal setting, sleep, stress, diet, and physical activity. Researchers want to see if the approach is feasible and acceptable, and whether it helps reduce pain and improve function.

What this could mean

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

Active substance
Multimodal lifestyle approach including pain education booklet and exercise therapy
What this could lead to
If successful, this program could offer a practical, non-drug way to help people with chronic pain better manage their symptoms and improve daily life.
What could go wrong
This is a very small pilot study with only 15 people and no comparison group, so results may not apply broadly. The program may not reduce pain significantly.

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 15 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

20 to 75 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: 1. Receiving rehabilitation services at the study site. 2. Aged 20 to 75 years. 3. Chronic pain lasting for at least 3 months. 4. Pain intensity of 3 or higher on an 11-point Numerical Rating Scale. 5. Suspected involvement of nociplastic pain, assessed using a screening procedure based on clinical criteria and grading for chronic nociplastic pain affecting the musculoskeletal system. 6. Able and willing to provide written informed consent. Screening Procedure for Nociplastic Pain Features The involvement of nociplastic pain features will be assessed before enrollment using a structured screening form developed by the research group based on the clinical criteria and grading system for chronic nociplastic pain affecting the musculoskeletal system proposed by Kosek et al. The screening form is not intended to establish a definitive diagnosis of nociplastic pain, but to identify patients with suspected nociplastic pain features for eligibility. The screening procedure includes assessment of pain duration, pain distribution, possible nociceptive and neuropathic pain mechanisms, hyperalgesia or allodynia, history of hypersensitivity, and comorbid symptoms related to central sensitization. The screening algorithm and assessment items will be documented in the study materials to improve transparency and reproducibility. Exclusion Criteria: 1. Presence of specific pain-related conditions or symptoms, including fracture, rheumatic disease, musculoskeletal surgery within the past 3 years, fibromyalgia, or complex regional pain syndrome. 2. Inability to follow the study schedule. 3. Receiving compensation for absence from work due to a traffic accident or work-related injury. 4. Difficulty using Japanese. 5. Cognitive impairment that may affect the assessment procedures or pain education. 6. Possibility of pregnancy during the study period. 7. Previous experience of Pain Neuroscience Education.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome Nociplastic Pain

As listed by the trial registrant

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

Chronic pain Nociplastic pain

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. 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

  • Prefectural University of Hiroshima

    Mihara, Hiroshima, 725-0053, Japan

  • SKY Clinic

    Ibaraki, Osaka, 567-0829, Japan

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