About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Online Psychologically-Informed Physical Therapy
BehavioralThe intervention consists of an individualized Psychologically-Informed Physical Therapy (PIPT) program delivered entirely remotely via Zoom. PIPT integrates physical rehabilitation with the identification and management of psychological and social factors that may influence pain perception, disability, and functional recovery, including fear of movement, dysfunctional beliefs, catastrophizing, and ineffective coping strategies. The intervention is not intended to treat primary psychological disorders; rather, it aims to help participants overcome psychosocial barriers to physical reactivation and develop effective self-management strategies. The program includes 12 scheduled sessions, with up to 3 additional optional sessions, delivered over 12 months. The first session lasts approximately 60-75 minutes, while subsequent sessions last approximately 30-45 minutes. Eight sessions are delivered during the first 3 months, with the remaining sessions scheduled over the following 9 months
Paper-based booklet
BehavioralThe control intervention consists of a paper-based Cognitive Behavioral Therapy booklet combined with a home exercise program. Participants will be instructed to perform the prescribed exercises three times per week during the first 3 months of the study. During this period, participants will receive a weekly telephone call from a physiotherapist to monitor adherence to the exercise program. These calls will be limited to adherence monitoring and will not include additional education, coaching, or therapeutic interaction aimed at reproducing components of the PIPT intervention. After the initial 3-month period, participants will receive additional follow-up telephone calls at 6 and 9 months after enrollment to monitor the progression of their condition. These contacts will likewise avoid patient education or therapeutic interaction intended to generate effects related to the therapeutic encounter.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Feasibility
Monthly enrollment rate and proportion of eligible individuals who enroll in the study. Recruitment feasibility will be evaluated according to prespecified traffic-light progression criteria: green, ≥75% of eligible individuals enrolled or ≥10 participants/month; amber, 50-74% or 5-7 participants/month; red, \<50% or \< 5 participant/month.
Consent Rate Among Eligible Participants
Proportion of eligible participants who provide informed consent to participate in the study. Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
Participant Retention Rate
Proportion of randomized participants who complete the primary feasibility assessment time point (T1). Prespecified progression criteria are: green, ≥80%; amber, 60-79%; red, \<60%.
Adherence to PIPT Sessions
Proportion of planned Psychologically-Informed Physical Therapy sessions completed by participants allocated to the intervention group. Prespecified progression criteria are: green, median adherence ≥70%; amber, 50-69%; red, \<50%.
Secondary outcomes
Revised Fibromyalgia Impact Questionnaire (FIQR)
21-item questionnaire assessing function, overall impact, and symptoms related to fibromyalgia. Total score ranges from 0 to 100, with higher scores indicating greater fibromyalgia impact.
Patient-Specific Functional Scale (PSFS)
Participants identify up to five activities they have difficulty performing and rate each from 0 ("unable to perform") to 10 ("able to perform at premorbid level"). The mean score represents patient-specific functional ability; higher scores indicate better function.
SF-12 Physical Component Summary (PCS)
Physical health component derived from the 12-Item Short Form Health Survey. Scores are transformed to norm-based values; higher scores indicate better physical health-related quality of life.
SF-12 Mental Component Summary (MCS)
Mental health component derived from the 12-Item Short Form Health Survey. Higher scores indicate better mental health-related quality of life.
Sponsors and contacts
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