Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

Hemophilia Clinical Trial

Official title:

Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549843
• Other study ID #: He-AnklePilot
• Status: Completed
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: February 26, 2023

Study information

• Verified date: February 2024
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 26, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Joint Diseases

Intervention

Other:
• Manual therapy
Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy.

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks	Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.	Screening visit, within the first seven days after treatment and after two months follow-up
Secondary	Change from baseline ankle joint pain after treatment and at 3 weeks	Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).	Screening visit, within the first seven days after treatment and after two months follow-up
Secondary	Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks	Pressure algometer. Measuring instrument used to evaluate pressure joint pain. The instrument shall consist of a measuring device attached to a hard rubber tip 1.1 cm in diameter. Its sphere shall be calibrated in kg/cm2 with divisions of 0.1 kg/cm2. The pressure algometry methodology applied was based mainly on the study by Hogeweg.; Before taking the measurements, patients will be instructed to say "yes" as soon as pressure exerted by the algometer becomes slightly unpleasant. The pressure algometer shall be kept perpendicular to the surface of the skin with the right hand, stabilizing the axis of the instrument using the thumb and index finger of the left hand. The pressure shall be increased at a uniform rate of approximately 1 kg/cm2 per second. As soon as the subject, according to the instructions, says "yes", the pressure will be stopped and the score will be noted.	Screening visit, within the first seven days after treatment and after two months follow-up
Secondary	Change from baseline ankle joint damage after treatment and at 3 weeks	Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of ankles. It includes 8 items (inflammation and its duration, pain, atrophy and muscle strength, crepitus, and reduced flexion and extension) ranging from 0 to 20 points per joint (the higher the score, the greater the joint deterioration).	Screening visit, within the first seven days after treatment and after two months follow-up
Secondary	Change from baseline ankle range of motion after treatment and at 3 weeks	Leg motion device. The test will be conducted in accordance with the procedures for conducting the weight-bearing lunge test. The subjects will stand to assess, in the Leg Motion system, with the big toe on the starting line and the knee touching a metal stick. While patients hold the position, they will be instructed on how to perform a lunge in which the knee will be flexed with the aim of touching a metal rod with its anterior part. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Maximum dorsiflexion ROM will be defined as the maximum distance from the toe to the metal rod while maintaining contact with the knee for three seconds, without lifting the heel. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot, first with one leg and then with the contralateral leg.	Screening visit, within the first seven days after treatment and after two months follow-up