Manual Therapy in Hemophilic Arthropathy of the Ankle

Официальное название

Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial

Обзор

Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy. Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia. Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.

Вмешательства

• Другое Manual Therapy
  The patients included in the experimental group will receive a 50-minute physiotherapy intervention involving global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding and triceps surae induction techniques
• Другое Placebo
  The patients included in the control group will receive a 50-minute physiotherapy intervention in which the physiotherapist's hands and the times per technique will be the same as in the experimental group, but without applying any sliding, mobilisation or manipulation

Первичные конечные точки

• Change from baseline hemarthrosis after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]

Вторичные конечные точки (6)

• Change from baseline pressure pain threshold after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
• Change from baseline joint status after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
• Change from baseline range of motion after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
• Change from baseline joint pain after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
• Change from baseline functional capacity after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]
• Change from baseline kinesiophobia after treatment and at four weeks [Срок оценки: Screening visit, within the first seven days after treatment and after four weeks follow-up visit]

Критерии участия

Критерии включения

• Patients diagnosed with haemophilia A and B
• With severe haemophilia phenotype (<1% FVIII/FIX)
• Over 18 years of age
• With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
• On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates

Критерии исключения

• Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
• Failure to sign the informed consent document

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Católica San Antonio — Murcia

Идентификаторы

NCT: NCT06816056 · HE-ANKLEran

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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