NCT07865403 Psychologically Informed Telerehabilitation for Fibromyalgia
| NCT ID | NCT07865403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2026-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fibromyalgia is a long-term condition that can cause widespread pain, fatigue, sleep problems, difficulties with concentration, and limitations in daily activities. Physical, psychological, and social factors can all influence how people experience and manage these symptoms. This study will examine whether an online Psychologically-Informed Physical Therapy (PIPT) program is feasible, acceptable, and safe for adults with fibromyalgia. PIPT is a physiotherapy approach that combines physical rehabilitation with attention to factors such as fear of movement, unhelpful beliefs about pain, coping strategies, and confidence in returning to meaningful activities. It is not intended to treat mental health disorders. Instead, the physiotherapist supports participants in understanding their pain, identifying personal goals, gradually increasing activity, and developing strategies to better manage their condition. This is a pilot randomized controlled trial involving approximately 32 adults aged 18 to 65 years with fibromyalgia. Participants will be randomly assigned to one of two groups. Participants in the PIPT group will receive an individualized program delivered remotely by videoconference. The program will include 12 sessions, with up to 3 additional optional sessions, over a period of 12 months. Most sessions will take place during the first 3 months. Sessions will include education about chronic pain, collaborative goal setting, discussion of barriers to activity, support for gradual physical reactivation, and development of self-management strategies. Participants in the comparison group will receive an educational booklet about pain neuroscience and a program of exercises to perform three times per week during the first 3 months. They will also receive scheduled telephone calls to monitor adherence and their clinical progress. The main purpose of this pilot study is not to determine definitively whether PIPT is better than the comparison program. Instead, the researchers will assess whether a larger clinical trial can be successfully conducted. They will examine recruitment, retention, attendance, completeness of study data, delivery of the intervention as planned, participant acceptability, technical problems during online sessions, and any adverse events. The study will also collect preliminary information about possible changes in fibromyalgia impact, physical function, quality of life, anxiety and depression, fear of movement, fear-avoidance beliefs, and physical performance. Brain activity will also be explored using electroencephalography (EEG). Participants receiving PIPT will additionally be invited to take part in interviews about their experiences with the program. These interviews will help researchers understand what participants found helpful or difficult, what may encourage or prevent engagement, and how the program could be improved. The results will be used to refine the intervention and study procedures and to determine whether a larger, fully powered randomized controlled trial of online PIPT for fibromyalgia should be undertaken.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07865403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07865403 currently recruiting?
Yes, NCT07865403 is actively recruiting participants. Contact the research team at matteocioeta@gmail.com for enrollment information.
Where is the NCT07865403 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07865403 clinical trial?
NCT07865403 is sponsored by IRCCS San Raffaele Roma. The trial plans to enroll 32 participants.
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