Manual Therapy in Hemophilic Arthropathy of the Ankle

Investigación en Hemofilia y Fisioterapia

Status: Enrolling

Conditions: Hemophilia A

Treatments: Other: Placebo; Other: Manual Therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06816056

HE-ANKLEran

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

The intervention will last 3 weeks, with a periodicity of 1 weekly sessions. In total there will be 3 sessions lasting 50 minutes. The techniques will be: global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding traction technique and triceps surae induction technique

Treatment:

Other: Manual Therapy

Control group

Placebo Comparator group

Description:

The patients included in the control group will receive the same physiotherapy intervention in the form of a placebo. The physiotherapist in charge of this intervention will perform the same number of techniques but without applying sliding stimuli, myofascial induction or manipulation. The hands will be positioned in the same way and the times per technique will be the same as in the techniques of the experimental group.

Treatment:

Other: Placebo