FibromyalgiaFibroPIPTNCT07865403
Psychologically Informed Telerehabilitation for Fibromyalgia
A study testing Online Psychologically-Informed Physical Therapy and Paper-based booklet in people with Fibromyalgia, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Online Psychologically-Informed Physical Therapy and Paper-based booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Roma
Rome, Rome, 00163
Sanaz Pournajaf, DPT, PhD, +39 0652252405 ext. 32405, sanaz.pournajaf@sanraffaele.it
Matteo Cioeta, PT, PhD fellow
About this study
Official title: Feasibility and Preliminary Efficacy of Psychologically Informed Physiotherapy Delivered Via Telerehabilitation in People With Fibromyalgia: A Pilot Study
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.
Read more
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.
- Conditions
- Fibromyalgia
- Being tested
- Online Psychologically-Informed Physical Therapy, Paper-based booklet
- Keywords
- Fibromyalgia, Psychologically-Informed Physical Therapy, PIPT, Telerehabilitation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Psychologically-Informed Physical TherapyBehavioural
The 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 bookletBehavioural
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Online Psychologically-Informed Physical Therapy (PIPT) | Experimental | Participants allocated to the experimental arm will receive 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, disability, and functional recovery, such as fear of movement, unhelpful beliefs, catastrophizing, and ineffective coping strategies. The intervention does not aim to treat primary psychological disorders, but to support participants in overcoming psychosocial barriers to physical reactivation and self-management.
The program will consist of 12 sessions, with up to 3 additional optional sessions, delivered over 12 months. The first session will last approximately 60-75 minutes, and subsequent sessions approximately 30-45 minutes. Eight sessions will be delivered during the first 3 months, while the remaining sessions will be scheduled over the following 9 months according to i Receives: Behavioral: Online Psychologically-Informed Physical Therapy |
| Paper-based booklet | Active comparator | Participants allocated to the control group will receive a paper-based informational booklet on Cognitive Behavioral Therapy together with a home exercise program to be performed three times per week during the first 3 months.
During this initial 3-month period, participants will receive a weekly telephone call from a physiotherapist to monitor adherence to the prescribed exercises. Additional follow-up telephone calls will be conducted at 6 and 9 months after enrollment to monitor the progression of the participant's condition.
These follow-up contacts will not include additional patient education or therapeutic interaction intended to reproduce components of the PIPT intervention. Receives: Behavioral: Paper-based booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the recruitment period.
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%.
Measured: At screening/enrollment.
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%.
Measured: At 3 months
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%.
Measured: Throughout the 12-month intervention period.
Completeness of Secondary Outcome Data
Proportion of participants with complete datasets for the prespecified secondary outcomes at the primary feasibility time point. Prespecified progression criteria are: green, ≥90%; amber, 75-89%; red, <75%.
Measured: At 3 months
Treatment Acceptability and Preferences (TAP) Score
Acceptability of the intervention will be assessed using the Treatment Acceptability and Preferences (TAP) measure, supplemented by brief exit interviews evaluating perceived value, burden, and usability of the telerehabilitation pathway. Higher TAP scores indicate greater treatment acceptability. Prespecified progression criteria are based on TAP scores, with scores ≥12 indicating the green progression category and scores <8 indicating the red category.
Measured: Following the intervention/at the prespecified acceptability assessment point.
Incidence of Intervention-Related Adverse Events and Serious Adverse Events
Number and proportion of participants experiencing adverse events (AEs) or serious adverse events (SAEs) considered related to the intervention. Events will be documented for severity, causality, actions taken, outcome, and follow-up. Prespecified progression criteria consider both the occurrence of SAEs and the proportion of participants experiencing mild or moderate AEs.
Measured: From enrollment through the final telerehabilitation session, up to 12 months.
Control Group Contamination Rate
Proportion of control-group participants reporting exposure to components similar to the PIPT intervention during the study. Prespecified progression criteria are: green, ≤10%; amber, 11-20%; red, >20%.
Measured: Throughout the study period, up to 12 months.
Successful Completion of Videoconference Sessions
Proportion of scheduled videoconference sessions completed without a technical interruption or dropout lasting more than 5 minutes. Prespecified progression criteria are: green, ≥90%; amber, 80-89%; red, <80%.
Measured: Throughout the 12-month intervention period.
Criteria for a definitive RCT
Consistent with the traffic light framework proposed by Avery et al., progression to a definitive RCT will be decided as follows: proceed (green) if ≥6 domains meet green thresholds and no domain is red; amend (amber) if ≤2 domains are red or if 3-5 domains are green; stop (red) if ≥3 domains are red or if a serious adverse event probably related to the intervention occurs alongside an unfavorable safety pattern
Measured: At the end of the intervention
Secondary outcomes (13)
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.
Measured: At 3 and 12 months
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.
Measured: At 3 and 12 months
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.
Measured: At 3 and 12 months
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.
Measured: At 3 and 12 months
HADS - Anxiety Subscale
Seven-item Hospital Anxiety and Depression Scale anxiety subscale, ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Measured: At 3 and 12 months
HADS - Depression Subscale
Seven-item Hospital Anxiety and Depression Scale depression subscale, ranging from 0 to 21. Higher scores indicate greater depressive symptoms.
Measured: At 3 and 12 months
Tampa Scale of Kinesiophobia (TSK)
17-item measure of pain-related fear of movement or reinjury, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.
Measured: At 3 and 12 months
Fear-Avoidance Beliefs Questionnaire - Physical Activity Subscale (FABQ-PA)
Subscale assessing fear-avoidance beliefs regarding physical activity, ranging from 0 to 24. Higher scores indicate stronger fear-avoidance beliefs.
Measured: At 3 and 12 months
Fear-Avoidance Beliefs Questionnaire - Work Subscale (FABQ-W)
Subscale assessing fear-avoidance beliefs regarding work, ranging from 0 to 42. Higher scores indicate stronger fear-avoidance beliefs.
Measured: At 3 and 12 months
30-Second Sit-to-Stand Test
Number of complete sit-to-stand repetitions performed from a standard chair within 30 seconds. A higher number of repetitions indicates better lower-limb functional performance.
Measured: At 3 months
Change from baseline in resting-state EEG microstate mean duration
Microstate mean duration will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Mean duration is defined as the average length of uninterrupted episodes assigned to a given microstate class, expressed in milliseconds. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention value minus the baseline value.
Measured: At 3 months
Change from baseline in resting-state EEG microstate occurrence rate
Microstate occurrence rate will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Occurrence rate is defined as the number of distinct episodes of a given microstate class per second of analyzed EEG, expressed as occurrences per second. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention value minus the baseline value.
Measured: At 3 months
Change from baseline in resting-state EEG microstate time coverage
Microstate time coverage will be derived from 128-channel electroencephalography (EEG) recorded during eyes-closed and eyes-open resting-state conditions. Time coverage is defined as the percentage of the total analyzed EEG recording time assigned to a given microstate class. Values will be calculated separately for each microstate class and each resting-state condition. Change will be calculated as the post-intervention percentage minus the baseline percentage and expressed in percentage points.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865403
- Sponsor's protocol ID
- 373/SR/25
- Acronym
- FibroPIPT
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The availability of individual participant data (IPD) has not yet been determined. Given the small sample size of this pilot trial and the inclusion of qualitative interview data, particular attention will be given to protecting participant confidentiality and minimizing the risk of re-identification. Any future sharing of de-identified quantitative IPD will be subject to applicable ethical approvals, participant consent, and data protection regulations. Analysis scripts will be made openly available to support transparency and reproducibility.
Publications
Sullivan MB, Hill K, Ballengee LA, Knoblach D, Fowler C, Haun J, Saenger M. Remotely Delivered Psychologically Informed Mindful Movement Physical Therapy for Pain Care: A Framework for Operationalization. Glob Adv Integr Med Health. 2023 Oct 25;12:27536130231209751. doi: 10.1177/27536130231209751. eCollection 2023 Jan-Dec.
PubMed 37901847Main CJ, George SZ. Psychologically informed practice for management of low back pain: future directions in practice and research. Phys Ther. 2011 May;91(5):820-4. doi: 10.2522/ptj.20110060. Epub 2011 Mar 30.
PubMed 21451091Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278