HemophiliaHEMO-TELENCT07682519
Multimodal Telerehabilitation Versus Face-to-Face Care for Adults With Hemophilia and Chronic Pain
A study testing other and Exercise in people with Hemophilia and Chronic Pain, run by University of Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Hemophilia, Chronic Pain
- What is being tested?
- other and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- 2 Jul 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, Faculty of Medicine, University of Chile
Santiago, Santiago Metropolitan, 80002
Rodrigo Núñez-Cortés, PhD, 928777254, r_nunez@uchile.cl
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hemophilia, Chronic Pain
- Being tested
- other, Exercise
- Medical subject headings
- Hemophilia A, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherBehavioural
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).
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: other; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the 6-week intervention.
Secondary outcomes (4)
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).
Measured: Baseline and immediately after the 6-week intervention.
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.
Measured: Baseline and immediately after the 6-week intervention.
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.
Measured: Baseline and immediately after the 6-week intervention
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.
Measured: Baseline and immediately after the 6-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start2 Jul 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RODRIGO NUNEZ, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682519
- Sponsor's protocol ID
- UI-001/25
- Acronym
- HEMO-TELE
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multimodal Telerehabilitation Intervention Versus Face-to-Face Care in Adults With Hemophilia and Chronic Pain: A Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07682519
- Acronym / sponsor ID
- HEMO-TELE / UI-001/25
- Conditions
- Hemophilia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Telerehabilitation | Experimental | Behavioral: other, Other: ExerciseParticipants 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. |
| Face-to-Face Multimodal Rehabilitation | Active comparator | Behavioral: other, Other: ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otherA 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). | Behavioural | Face-to-Face Multimodal Rehabilitation, Multimodal Telerehabilitation |
| ExerciseA 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. | Other | Face-to-Face Multimodal Rehabilitation, Multimodal Telerehabilitation |
Primary outcome
Pain Intensity
Time frame: 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.
4 secondary outcomes
Kinesiophobia
Time frame: Baseline and immediately after the 6-week intervention.
Pain Self-Efficacy
Time frame: Baseline and immediately after the 6-week intervention.
Functional Performance
Time frame: Baseline and immediately after the 6-week intervention
Pressure Pain Threshold
Time frame: Baseline and immediately after the 6-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing other and Exercise in people with Hemophilia and Chronic Pain, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Núñez-Cortés, PhD (+56928777254, r_nunez@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and immediately after the 6-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.