Clinical trial NCT03009591: Fascial Therapy in Elbow Hemophilic Arthropathy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilia
Elbow
Arthropathy
Joint pain
Range of motion
Myofascial techniques
Safety patients
Quality of life
Functionality
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 69
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline elbow joint bleeding frequency after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary outcomes:
measure: Change from baseline range of motion of elbow after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline elbow joint status after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline joint pain of elbow after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline upper limb functionality after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline quality of life after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Royal Victoria Eugenia Foundation
state: Madird
Study officials:
References:
citation: 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.
citation: 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.