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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Spain
Universidad Católica San Antonio
RECRUITING
Murcia
Contact Information
Primary
Rubén Cuesta-Barriuso, PhD
cuestaruben@uniovi.es
607547274
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2025-07-25
Participants
Target number of participants: 13
Treatments
Experimental: Experimental group
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
Placebo_comparator: Control group
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.
Related Therapeutic Areas
Sponsors
Leads: Investigación en Hemofilia y Fisioterapia

This content was sourced from clinicaltrials.gov