Clinical trial NCT04237766: Movement Visualization in Patients With Hemophilic Arthropathy
Official title: Safety and Effectiveness of a Physiotherapy Intervention Through Movement Visualization in the Approach of Pain in Patients With Hemophilic Arthropathy. Multicenter Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilic arthropathy
Educative intervention
Pain
Quality of life
Anxiety
Stress
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.

Objective. Assess the safety and efficacy of an intervention in pain through visualization of the movement using a mobile application of augmented reality and immersive 360º video, regarding the frequency of bleeding and the improvement of pain perception and quality of life, joint state , strength and functionality in patients with hemophilic arthropathy.

Study design. Randomized, multicenter, simple blind clinical study.

Method. 140 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a 6-month follow-up period.

Expected results. Observe the effectiveness of movement visualization in the characteristics of pain, and its implication in functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Medical diagnosis of hemophilic arthropathy
* Chronic joint pain
* Over 18 years
* On prophylactic treatment or on demand with FVIII / FIX concentrates

Exclusion Criteria:

* Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
* Painless patients
* Amputee, epileptic or seriously impaired vision patients
* Patients receiving physiotherapy treatment at the time of the study
* Patients who have not signed the informed consent document.

Primary outcomes:
measure: Change from baseline joint bleeding frequency after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Secondary outcomes:
measure: Change from baseline joint pain after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline joint pain perception after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline muscle strength after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline electrical muscle activity after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline perception of quality of life after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline anxiety perception after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline fear of movement after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline catastrophism after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline anxiety perceived after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline endogenous pain inhibitory system after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
measure: Change from baseline joint status after treatment and at 6 months
timeFrame: Screening visit, within the first seven days after treatment and after six months follow-up visit
Other outcomes:
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