Clinical trial NCT05549843: Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
Official title: Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2022-09-22
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy.

Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain.

Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally.

Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* With severe (\<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
* Over 18 years
* With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
* In prophylactic treatment with FVIII / FIX concentrates for coagulation

Exclusion Criteria:

* Patients with inhibitors (antibodies against FVIII or FIX)
* Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
* Failure to sign the informed consent document

Primary outcomes:
measure: Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up
Secondary outcomes:
measure: Change from baseline ankle joint pain after treatment and at 3 weeks
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up
measure: Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up
measure: Change from baseline ankle joint damage after treatment and at 3 weeks
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up
measure: Change from baseline ankle range of motion after treatment and at 3 weeks
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
References: