Multimodal Telerehabilitation Versus Face-to-Face Care for Adults With Hemophilia and Chronic Pain (HEMO-TELE)
Effects of a Multimodal Telerehabilitation Intervention Versus Face-to-Face Care in Adults With Hemophilia and Chronic Pain: A Randomized Controlled Non-Inferiority Trial
Hemophilia is an inherited bleeding disorder that is commonly associated with chronic joint pain, reduced physical function, and decreased quality of life. Pain science education combined with exercise therapy has shown beneficial effects in people with chronic musculoskeletal pain; however, its effectiveness in people with hemophilia remains largely unknown. Telerehabilitation may improve access to rehabilitation by reducing geographical and transportation barriers, but its effectiveness compared with face-to-face delivery has not been established in this population.
This randomized controlled non-inferiority trial will compare a 6-week multimodal telerehabilitation program consisting of pain science education and therapeutic exercise with an equivalent face-to-face program in adults with hemophilia and chronic pain. Participants will be randomly assigned to one of the two interventions. Clinical outcomes will be assessed before and after the intervention by an assessor blinded to group allocation. The study aims to determine whether telerehabilitation provides clinical outcomes that are not inferior to those achieved with conventional face-to-face rehabilitation.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Chronic pain affects nearly half of adults with hemophilia and is associated with impaired physical function, kinesiophobia, reduced self-efficacy, and poorer quality of life. Recurrent joint bleeding and hemophilic arthropathy contribute to persistent pain and disability, highlighting the need for accessible and effective rehabilitation strategies.
Pain science education (PSE) is an educational intervention designed to improve understanding of the biological and psychosocial mechanisms underlying persistent pain, reduce pain-related threat, and promote adaptive health behaviors. When combined with exercise therapy, PSE has demonstrated beneficial effects in individuals with chronic musculoskeletal disorders. However, evidence supporting its use in people with hemophilia is scarce.
Telerehabilitation has emerged as a promising strategy to improve access to rehabilitation services by reducing travel burden and geographical barriers while maintaining treatment adherence. Although previous studies suggest that telerehabilitation may provide outcomes comparable to conventional rehabilitation in several musculoskeletal conditions, no randomized controlled trial has compared multimodal pain science education plus exercise delivered by telerehabilitation with an equivalent face-to-face program in adults with hemophilia and chronic pain.
This study is a single-center, randomized, assessor-blinded, parallel-group non-inferiority trial. Participants will be randomly allocated (1:1) to receive either a 6-week telerehabilitation program or an equivalent face-to-face program. Both groups will receive the same educational content and exercise protocol, differing only in the mode of delivery.
The primary objective is to determine whether multimodal telerehabilitation is non-inferior to face-to-face rehabilitation in reducing pain intensity and improving pain sensitivity. Secondary objectives include evaluating changes in kinesiophobia, self-efficacy, joint health, functional performance, and patient-perceived improvement.
The results of this trial will provide evidence regarding the effectiveness of multimodal telerehabilitation for adults with hemophilia and may support the implementation of accessible rehabilitation models in clinical practice.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Rodrigo Núñez-Cortés, PhD
- Telefonní číslo: +56928777254
- E-mail: r_nunez@uchile.cl
Studijní místa
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 80002
- Nábor
- Department of Physical Therapy, Faculty of Medicine, University of Chile
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Kontakt:
- Rodrigo Núñez-Cortés, PhD
- Telefonní číslo: 928777254
- E-mail: r_nunez@uchile.cl
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Male adults aged 18 to 60 years. Diagnosis of hemophilia A or hemophilia B. Chronic pain, defined as pain occurring every day for at least 3 months or on at least half of the days during the previous 6 months.
Pain involving the elbow, knee, or ankle. Receiving prophylactic clotting factor replacement therapy at least three times per week.
Current medical referral for physical therapy. Residence in the Metropolitan Region of Chile. Ability to understand study procedures and provide written informed consent.
Exclusion Criteria:
Inability to understand study instructions or provide written informed consent. Neurological disorders affecting the central nervous system (e.g., stroke). Current participation in alternative therapies for pain management. Previous participation in a pain neuroscience education program. Orthopedic surgery or major musculoskeletal trauma within the previous 12 months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Multimodal Telerehabilitation
Participants will receive a 6-week multimodal telerehabilitation program consisting of pain neuroscience education and supervised therapeutic exercise.
Pain neuroscience education will be delivered once weekly via videoconference, together with a standardized exercise program including warm-up, mobility, stretching, and progressive strengthening exercises.
Both educational content and exercise prescription will be identical to the face-to-face intervention, differing only in the mode of delivery.
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A standardized pain neuroscience education program delivered once weekly for 6 weeks.
Educational sessions focus on the neurobiology and neurophysiology of pain, pain modulation, central sensitization, the influence of cognitive and emotional factors on pain, and strategies to promote adaptive self-management and behavior change.
The educational content is identical in both study arms and differs only in the mode of delivery (telerehabilitation or face-to-face).
A standardized supervised exercise program delivered once weekly for 6 weeks.
Each session includes a warm-up, joint mobility exercises, stretching, and progressive strengthening exercises for major muscle groups.
Exercise intensity is progressively increased according to participants' perceived exertion using the Borg CR10 scale.
The exercise protocol is identical in both study arms and differs only in the mode of delivery.
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Aktivní komparátor: Face-to-Face Multimodal Rehabilitation
Participants will receive a 6-week face-to-face multimodal rehabilitation program consisting of pain neuroscience education and supervised therapeutic exercise.
Sessions will be delivered once weekly at the Department of Physical Therapy, University of Chile.
The educational content and exercise program will be identical to those provided in the telerehabilitation group, differing only in the mode of delivery.
|
A standardized pain neuroscience education program delivered once weekly for 6 weeks.
Educational sessions focus on the neurobiology and neurophysiology of pain, pain modulation, central sensitization, the influence of cognitive and emotional factors on pain, and strategies to promote adaptive self-management and behavior change.
The educational content is identical in both study arms and differs only in the mode of delivery (telerehabilitation or face-to-face).
A standardized supervised exercise program delivered once weekly for 6 weeks.
Each session includes a warm-up, joint mobility exercises, stretching, and progressive strengthening exercises for major muscle groups.
Exercise intensity is progressively increased according to participants' perceived exertion using the Borg CR10 scale.
The exercise protocol is identical in both study arms and differs only in the mode of delivery.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity
Časové okno: Baseline and immediately after the 6-week intervention.
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Pain intensity will be assessed using the 100-mm Visual Analog Scale (VAS) for Pain, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain).
Higher scores indicate greater pain intensity.
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Baseline and immediately after the 6-week intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pressure Pain Threshold
Časové okno: Baseline and immediately after the 6-week intervention.
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Pressure pain threshold will be assessed using a digital pressure algometer.
The average of three measurements will be recorded at each assessment.
Higher values indicate lower pain sensitivity.
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Baseline and immediately after the 6-week intervention.
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Kinesiophobia
Časové okno: Baseline and immediately after the 6-week intervention.
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Kinesiophobia will be assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11).
Total scores range from 11 to 44, with higher scores indicating greater fear of movement (kinesiophobia).
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Baseline and immediately after the 6-week intervention.
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Pain Self-Efficacy
Časové okno: Baseline and immediately after the 6-week intervention.
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Pain self-efficacy will be assessed using the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2).
Total scores range from 0 to 12, with higher scores indicating greater confidence in performing activities despite pain.
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Baseline and immediately after the 6-week intervention.
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Functional Performance
Časové okno: Baseline and immediately after the 6-week intervention
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Functional performance will be assessed using the 30-Second Sit-to-Stand Test (30s STS).
The outcome is the number of completed sit-to-stand repetitions performed in 30 seconds.
Higher values indicate better functional performance.
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Baseline and immediately after the 6-week intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Genetické choroby, vrozené
- Hematologická onemocnění
- Poruchy srážení krve
- Hemoragické poruchy
- Poruchy srážení krve, dědičné
- Poruchy koagulačního proteinu
- Vrozené, dědičné a neonatální nemoci a abnormality
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Hemická a lymfatická onemocnění
- Chronická bolest
- Hemofilie A
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Cvičení
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