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Completed

NCT Number: NCT03009591

Fascial Therapy in Elbow Hemophilic Arthropathy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Eugenia Foundation

Madrid, Madird, 28029, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fascial therapy group

Primary outcomes

  1. Change from baseline elbow joint bleeding frequency after treatment and at 3 months

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

    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.

Secondary outcomes

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

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

    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

  2. Change from baseline elbow joint status after treatment and at 3 months

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

    Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).

  3. Change from baseline joint pain of elbow after treatment and at 3 months

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

    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).

  4. Change from baseline upper limb functionality after treatment and at 3 months

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

    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.

  5. Change from baseline quality of life after treatment and at 3 months

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

    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.

Sponsors and collaborators

Lead sponsor

Real Fundación Victoria Eugenia

Other

Registry information

Official study title

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

Acronym: HeL-Fascial

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 4, 2017
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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