Multimodal Telerehabilitation Versus Face-to-Face Care for Adults With Hemophilia and Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorUniversity of Chile
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
other
BehavioralA 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).
Exercise
Other interventionA 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Multimodal TelerehabilitationExperimental treatment 2 interventions
Group B: Face-to-Face Multimodal RehabilitationActive comparator 2 interventions
Trial outcomes
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.
Time frame
Baseline and immediately after the 6-week intervention.Secondary outcomes
1
Kinesiophobia
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).
Time frame
Baseline and immediately after the 6-week intervention.2
Pain Self-Efficacy
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.
Time frame
Baseline and immediately after the 6-week intervention.3
Functional Performance
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.
Time frame
Baseline and immediately after the 6-week intervention4
Pressure Pain Threshold
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.
Time frame
Baseline and immediately after the 6-week intervention.Sponsors and contacts
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Source ClinicalTrials.gov