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NCT Number: NCT03914287

Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.

Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.

Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). 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, functionality and joint motion is expected.

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Key information

Conditions

Hemophilia 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

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with hemophilia A and B disease.
  • Over 18 years.
  • Diagnosed with hemophilic arthropathy of the ankle (by clinical assessment with the Hemophilia Joint Health Score).
  • On prophylactic or on demand treatment with FVIII / FIX concentrates.

Exclusion criteria

  • Patients without ambulation ability.
  • Patients with inhibitors (antibodies to FVIII or FIX).
  • Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests.
  • Not signed the informed consent document.

Treatment and study plan

Self-myofascial release

Other

The Self-Myofascial release protocol for the lower limbs using a Foam Roller will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; release of the myofascial components of the back of the leg using a Foam Roller; release of the myofascial components of the anterior part of the leg using a Foam Roller; release of myofascial components of the hamstring region using a Foam Roller; release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.

Primary outcomes

  1. Change from baseline ankle joint pain after treatment and at 3 months

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

    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).

Secondary outcomes

  1. Change from baseline ankle joint pain after treatment and at 3 months

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

    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.

  2. Change from baseline lower 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

    Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of knees, ankles, and elbows. 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).

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

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

    Digital Goniometry Ankle ROM shall be measured using a digital goniometer. The assessment can be made with the patient standing. This measuring instrument allows more accurate measurements than those obtained with a universal plastic goniometer.

  4. Change from baseline muscle strength after treatment and at 3 months

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

    Dynamometry. The maximum isometric strength of the flexor and extensor muscles of the main joints affected in hemophilia (knees and ankles) will be evaluated on both limbs with a manual dynamometer using a mark test. For this test, the rater needs to keep the dynamometer stationary while the patient exerts maximum force against it.

  5. Change from baseline muscle flexibility after treatment and at 3 months

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

    Fingertip-to-Floor Test. This test is used to assess the degree of flexibility of the posterior muscles of the lower limbs. This value is calculated as the distance between the fingertip and the floor when maximum hip flexion with knee extension is performed.

Sponsors and collaborators

Lead sponsor

Investigación en Hemofilia y Fisioterapia

Network

Registry information

Official study title

Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy. A Randomized Clinical Trial.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Sep 2, 2021

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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