Clinical trial NCT04549402: Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.
Official title: Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Haemophilia
Keywords: Hemophilic arthropathy
Educative intervention
Pain
Quality of life
Anxiety
Stress
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-09-16
Enrollment: 70
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 a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.

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

Study design. Randomized, multicenter, single-blind clinical study. Method. 70 patients with hemophilia A and B will be recruited in this study. The 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 analog scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire of Anxiety Status-Trait-STAI), joint status (Hemophilia Joint Health Score scale), muscle 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 follow-up period of 6 months.

Expected results. To observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the 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
* Patients with a medical diagnosis of hemophilic arthropathy and pain
* People over 18 years of age
* Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates

Exclusion Criteria:

* Patients with neurological or cognitive disorders that impede understanding of the questionnaires
* Pain free patients
* Amputees, epileptics or patients with severe vision problems
* Patients who are receiving Physiotherapy treatment at the time of the study
* Patients who have not signed the informed consent document

Primary outcomes:
measure: Change from baseline hemarthrosis after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Secondary outcomes:
measure: Change from baseline joint pain after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline pressure pain threshold after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline muscle strength after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline electrical activity of the muscles after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline perception of quality of life after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline perception of anxiety after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline kinesiophobia after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline catastrophizing after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline joint status after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: European University of Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: