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Psychologically Informed Telerehabilitation for Fibromyalgia

A legfontosabb adatok

Ki végzi
IRCCS San Raffaele Roma
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
32 fő, tervezett
Kezdés
2026. szept. 1.
Várható befejezés
2027. szept. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Online Psychologically-Informed Physical Therapy
  • Paper-based booklet
A regiszteradat frissítve
2026. október 8.

Ki vehet részt

Életkor
18 év – 70 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 7 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 70 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Online Psychologically-Informed Physical Therapy (PIPT)A vizsgált kezelés

    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

    Kezelés: Online Psychologically-Informed Physical Therapy

  • Paper-based bookletMár használt kezelés, összehasonlításként

    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.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Feasibility and Preliminary Efficacy of Psychologically Informed Physiotherapy Delivered Via Telerehabilitation in People With Fibromyalgia: A Pilot Study
Illeszkedési kérdések
Forrás: NCT07865403: ki vehet részt
A regiszteradat frissítve
2026. október 8.