Clinical, Functional and Musculoskeletal Differences Between Adult Patients With Hemophilia and Their Healthy Peers

Analysis of Clinical, Functional and Musculoskeletal Variables Between Adult Patients With Hemophilic Arthropathy of the Knee and Ankle and Their Healthy Peers. A Case-control Study

Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.

Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.

Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.

Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).

Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemophilia Arthropathy
• Intervention / Treatment: Other: Clinical and functional assessment

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

• Study Contact: Name: Rubén Cuesta-Barriuso, PhD; Phone Number: 0034985103386; Email: cuestaruben@uniovi.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilic arthropathy and their healthy pairs

Description

Inclusion Criteria:

• Patients diagnosed with hemophilia A and B.
• Over 18 years
• With medical diagnosis of knee arthropathy
• With clinical evaluation by Hemophilia Joint Health Score
• In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
• Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.

Exclusion Criteria:

• Patients with neurological or cognitive disorders that prevent the understanding of physical tests
• Not having signed the informed consent document

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemophilia group; Patients with hemophilia, older than 18 years, with a diagnosis of hemophilic arthropathy of the knee and ankle. The different study variables will be evaluated following the indicated protocol.	Other: Clinical and functional assessment; The dependent variables (muscle strength, muscle activation, pressure pain threshold and joint status) and the outcome measures used to measure these variables will be: pressure dynamometer, surface electromyography, pressure algometer and Hemophilia Joint Health Score
Healthy peers.group; Healthy subjects, older than 18 years, without joint damage at the time of the study, and physically active. The different study variables will be evaluated following the indicated protocol.	Other: Clinical and functional assessment; The dependent variables (muscle strength, muscle activation, pressure pain threshold and joint status) and the outcome measures used to measure these variables will be: pressure dynamometer, surface electromyography, pressure algometer and Hemophilia Joint Health Score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the muscle strength	The force will be measured with a pressure dynamometer (Lafayette Manual muscle Tester model 01165). This device measures in Newton the force exerted by the patient in the requested muscular action. The higher the value, the greater muscle strength. We will perform the measurements bilaterally. Strength in the quadriceps and triceps surae muscles will be measured. The patient will be asked for 2 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them. In all the measurements, the evaluator will encourage the patient in a standardized way to carry out the contractions. In the measurement of the strength of all the muscles evaluated, the mean value of the measurements obtained will be used as a measure.	Screening visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the muscle activation	Muscle activation will be measured with surface electromyography (Shimmer Sensing model, Dublin, Ireland). Using this instrument, we will evaluate the electrical activity of the muscles and their level of activation. The placement of the electrodes will be marked on the subjects standing, and they will be placed following the European recommendations for the use of SEMG. A bipolar SEMG system will be used with circular electrodes 10 mm in diameter, 20 mm apart, placed longitudinally, in the direction of the muscle fibers studied, and with a reference electrode at a distance. The unit of measure is the μV. The higher the score, the greater muscle activation.	Screening visit
Assess the pressure pain threshold	Pressure pain threshold will be measured with a pressure algometer (Wagner FPIXTM Digital Algometer model). This device measures in Newton/cm2 the pressure at which the subject perceives pressure pain. A pressure will be applied that we will increase at an approximate speed of 50kPa/s until the patient tells us that the sensation is beginning to be painful. In the knee we will measure bilaterally 3 cm medially to the midpoint of the inner edge of the patella, 2 cm proximally to the superior pole of the patella. At the ankle we will measure bilaterally ventrally to the lateral malleolus.	Screening visit
Assess the joint status	In patients with hemophilia, joint status will be assessed with the Hemophilia Joint Health Score. This specific scale for use in patients with hemophilia is used to measure the joint status of patients with hemophilic arthropathy. It evaluates 8 items: inflammation and its duration, pain, muscle atrophy and strength, crackles, and loss of flexion and extension. It has a score of 0 (no joint damage) to 20 points (maximum joint damage) per joint (elbows, knees and ankles). A gait rating is added to 120 points (range 0-4 points), with the maximum rating on this scale being 124 points.	Screening visit

Collaborators and Investigators

• Sponsor: Investigación en Hemofilia y Fisioterapia
• Investigators: Principal Investigator: Rubén Cuesta-Barriuso, PhD, University of Oviedo

Study record dates

Study Major Dates

• Study Start (Anticipated): November 21, 2022
• Primary Completion (Anticipated): November 28, 2022
• Study Completion (Anticipated): December 23, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Knee; Muscle activation; Strength; Ankle; Hemophilic arthropathy; Pressure pain threshold
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Blood Coagulation Disorders; Hemophilia A; Joint Diseases
• Other Study ID Numbers: He-BloodCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No