Fascial Therapy in Elbow Hemophilic Arthropathy (HeL-Fascial)

Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.

Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.

Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.

Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.

Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:

Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.

Study Overview

• Status: Completed
• Conditions: Hemophilia
• Intervention / Treatment: Other: Experimental group

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madird
    • Madrid, Madird, Spain, 28029
      • Royal Victoria Eugenia Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients diagnosed with hemophilia A and B
• Patients adults (over 18 years)
• Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
• Patients pn prophylactic treatment with FVIII / FIX concentrates.

Exclusion Criteria:

• Patients without ambulation ability
• Patients with inhibitors
• Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
• Patients who have not signed the informed consent document.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expermiental group; All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:	Other: Experimental group; Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.; Transverse sliding of the flexor muscles of the wrist and fingers.; Transverse sliding for the biceps brachii muscle.; Longitudinal surface sliding over the superficial fascia in the posterior arm region.; Transverse sliding over the brachial triceps tendon.; Transverse sliding for the pectoralis major muscle.; Transverse sliding for the posterior axillary region pectoralis major muscle.; Induction of the posterior axillary fold.; Induction (crossed hands over the brachial region and forearm).; Maneuver of transverse planes for the cervicothoracic region.; Upper limb telescopic maneuver.; Other Names: Fascial therapy group
No Intervention: Control group; Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline elbow joint bleeding frequency after treatment and at 3 months	After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.	Screening visit, within the first seven days after treatment and after three months follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline range of motion of elbow after treatment and at 3 months	Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia	Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline elbow joint status after treatment and at 3 months	Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).	Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline joint pain of elbow after treatment and at 3 months	Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).	Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline upper limb functionality after treatment and at 3 months	Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality.	Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline quality of life after treatment and at 3 months	Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study.	Screening visit, within the first seven days after treatment and after three months follow-up visit

Collaborators and Investigators

• Sponsor: Real Fundación Victoria Eugenia

Publications and helpful links

General Publications

• Cuesta-Barriuso R, Meroño-Gallut J, Donoso-Úbeda E, López-Pina JA, Pérez-Llanes R. Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 May;103(5):867-874. doi: 10.1016/j.apmr.2021.12.023. Epub 2022 Jan 23.
• Cuesta-Barriuso R, Perez-Llanes R, Lopez-Pina JA, Donoso-Ubeda E, Merono-Gallut J. Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial. Disabil Rehabil. 2022 Jul;44(15):3938-3945. doi: 10.1080/09638288.2021.1894607. Epub 2021 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Functionality; Arthropathy; Range of motion; Joint pain; Hemophilia; Elbow; Myofascial techniques; Safety patients
• 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: HeL-Fascial

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
• product manufactured in and exported from the U.S.: No