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Multimodal Telerehabilitation Versus Face-to-Face Care for Adults With Hemophilia and Chronic Pain (HEMO-TELE)

3. juli 2026 opdateret af: RODRIGO NUNEZ, University of Chile

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Rodrigo Núñez-Cortés, PhD
  • Telefonnummer: +56928777254
  • E-mail: r_nunez@uchile.cl

Studiesteder

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 80002
        • Rekruttering
        • Department of Physical Therapy, Faculty of Medicine, University of Chile
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: other
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).
Andet: Exercise
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.
Aktiv komparator: 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.
Adfærdsmæssigt: other
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).
Andet: Exercise
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity
Tidsramme: Baseline and immediately after the 6-week intervention.
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.
Baseline and immediately after the 6-week intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pressure Pain Threshold
Tidsramme: Baseline and immediately after the 6-week intervention.
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.
Baseline and immediately after the 6-week intervention.
Kinesiophobia
Tidsramme: Baseline and immediately after the 6-week intervention.
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).
Baseline and immediately after the 6-week intervention.
Pain Self-Efficacy
Tidsramme: Baseline and immediately after the 6-week intervention.
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.
Baseline and immediately after the 6-week intervention.
Functional Performance
Tidsramme: Baseline and immediately after the 6-week intervention
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.
Baseline and immediately after the 6-week intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Chile

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juli 2026

Primær færdiggørelse (Anslået)

15. januar 2027

Studieafslutning (Anslået)

15. januar 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UI-001/25

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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