Psychologically Informed Physical Therapy (PIPT) for Fibromyalgia delivered online
Official title: Feasibility and Preliminary Efficacy of Psychologically Informed Physiotherapy Delivered Via Telerehabilitation in People With Fibromyalgia: A Pilot Study
Run by IRCCS San Raffaele Roma · NCT07865403 · Data updated 2026-11-12
A small online program tests if a psychologically informed physical therapy approach is feasible, acceptable, and safe for adults with fibromyalgia to help manage symptoms and improve daily functioning.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07865403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with a fibromyalgia diagnosis (per 2016 ACR criteria) who can access the internet and understand Italian.
✕Probably not a fit
Some participants may not experience noticeable benefits from the online PIPT program or may not complete the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized trial will enroll about 32 adults with fibromyalgia to test an online Psychologically Informed Physical Therapy (PIPT) program. The intervention combines physical rehabilitation with strategies to address fear of movement, pain beliefs, coping, and activity resumption, delivered digitally; a paper-based booklet serves as a supplementary resource. Participants will be assigned to receive the online PIPT in addition to standard care, with safety and feasibility outcomes and participant acceptability assessed. The study is conducted at IRCCS San Raffaele Roma in Italy and focuses on feasibility, acceptability, and safety rather than efficacy outcomes. This research aims to determine whether a scalable telehealth approach to PIPT could be integrated into fibromyalgia management if shown to be feasible.
Why it matters
Potential benefit: If successful, participants could experience better pain management, functional improvement, and greater confidence in engaging in activities.
How similar studies have gone: Previous work on psychological and physical therapy approaches suggests potential benefits, but online PIPT for fibromyalgia is relatively novel and feasibility-focused here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria. * Age between 18 and 70 years. * Sufficient understanding of the Italian language. * Access to a good internet connection. Exclusion Criteria: * Any condition that, in the investigator's opinion, may interfere with participation in the study. * Any condition that, in the investigator's opinion, may contraindicate participation for safety reasons. * Failure to provide informed consent to participate in the study.
Where it's running
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IRCCS San Raffaele Roma
Rome, Rome, Italy Recruiting
Study contacts
- Study coordinator: Matteo Cioeta, MSc
- Email: matteocioeta@gmail.com
- Phone: +39 3331421032
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.