Multimodal Telerehabilitation Versus Face-to-Face Care for Adults With Hemophilia and Chronic Pain

NCT07682519 | Recruiting

• 1 other identifier: UI-001/25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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.

Secondary Outcomes (4)

• Kinesiophobia

  Baseline and immediately after the 6-week intervention.

• Pain Self-Efficacy

  Baseline and immediately after the 6-week intervention.

• Functional Performance

  Baseline and immediately after the 6-week intervention

• Pressure Pain Threshold

  Baseline and immediately after the 6-week intervention.

Study Arms (2)

Multimodal Telerehabilitation

EXPERIMENTAL

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.

Behavioral: other; Other: Exercise

Face-to-Face Multimodal Rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: other; Other: Exercise

Interventions

other BEHAVIORAL

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).

Face-to-Face Multimodal Rehabilitation; Multimodal Telerehabilitation

Exercise OTHER

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.

Face-to-Face Multimodal Rehabilitation; Multimodal Telerehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Department of Physical Therapy, Faculty of Medicine, University of Chile

Santiago, Santiago Metropolitan, 80002, Chile

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rodrigo Núñez-Cortés, PhD

CONTACT

+56928777254; r_nunez@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)