NCT04549402

Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.

Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Investigación en Hemofilia y Fisioterapia · Network
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Haemophilia

Interventions

Type	Name	Description
OTHER	Mirror Therapy group	The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
OTHER	Video group	The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-02-01
• Completion: 2022-05-01
• First posted: 2020-09-16
• Last updated: 2022-03-31

Locations

1 site across 1 country: Spain