Fascial Therapy in Elbow Hemophilic Arthropathy

NCT03009591 | Completed

• 1 other identifier: HeL-Fascial
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia

Keywords

Hemophilia; Elbow; Arthropathy; Joint pain; Range of motion; Myofascial techniques; Safety patients; Quality of life; Functionality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline range of motion of elbow after treatment and at 3 months

  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

  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

  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

  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

  Screening visit, within the first seven days after treatment and after three months follow-up visit

Study Arms (2)

Expermiental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Experimental group OTHER

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.

Also known as: Fascial therapy group

Expermiental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

Study Sites (1)

Royal Victoria Eugenia Foundation

Madrid, Madird, 28029, Spain

Location

Related Publications (2)

• Cuesta-Barriuso R, Merono-Gallut J, Donoso-Ubeda E, Lopez-Pina JA, Perez-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.

  PMID: 35081366 DERIVED

• 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.

  PMID: 33684015 DERIVED

MeSH Terms

Conditions

Hemophilia A; Joint Diseases; Arthralgia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 4, 2017
• Study Start: February 12, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 15, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)