Clinical trial NCT06816056: Manual Therapy in Hemophilic Arthropathy of the Ankle
Official title: Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemophilia A
Keywords: Hemophilic arthropathy
Ankle
Manual therapy
Joint pain
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2025-02-10
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline hemarthrosis after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Secondary outcomes:
measure: Change from baseline pressure pain threshold after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline joint status after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline range of motion after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline joint pain after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline functional capacity after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
measure: Change from baseline kinesiophobia after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: