Manual Therapy in Hemophilic Arthropathy of the Ankle
ConditionHemophilia A
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorInvestigación en Hemofilia y Fisioterapia
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
Manual Therapy
Other interventionThe 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
Placebo
Other interventionThe 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
Treatment groups
13 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline hemarthrosis after treatment and at four weeks
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
Time frame
Screening visit, within the first seven days after treatment and after four weeks follow-up visitSecondary outcomes
1
Change from baseline pressure pain threshold after treatment and at four weeks
Using a pressure algometer (model Wagner FPN100) we will measure the pain threshold to pressure, at the level of the joint and at a distance (in another part of the body). This device measures in Newton/cm2 the pressure at which the subject perceives pain under pressure. Pressure will be applied to the chosen point, which will be increased at a rate of approximately 50 kPa/s until the patient informs us that the sensation is starting to become painful. The lateral and medial malleoli of the ankle will be evaluated
Time frame
Screening visit, within the first seven days after treatment and after four weeks follow-up visit2
Change from baseline joint status after treatment and at four weeks
Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Time frame
Screening visit, within the first seven days after treatment and after four weeks follow-up visit3
Change from baseline range of motion after treatment and at four weeks
Change from range of movement of ankle during treatment and follow-up period at four weeks. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons
Time frame
Screening visit, within the first seven days after treatment and after four weeks follow-up visit4
Change from baseline joint pain after treatment and at four weeks
Change in ankle intensity during treatment and the four-week follow-up period. Ankle joint pain intensity will be measured using the visual analogue scale with a range of 0 to 10 points, where the higher the score, the greater the perception of joint pain
Time frame
Screening visit, within the first seven days after treatment and after four weeks follow-up visitSponsors and contacts
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Source ClinicalTrials.gov