Clinical trial NCT02198040: Physiotherapy in the Haemophilic Arthropathy of the Elbow.
Official title: Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Hemophilia
Keywords: Elbow
Joint disease
Hemophilia
Physiotherapy modalities
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation (PNF), and the other with education sessions and home exercises, for the improvement of the ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of the elbow.

Detailed description: The intervention was carried out during twelve weeks, performing evaluations before and after treatment, and six months of finalizing this. The treatment of MT group consisted of two sessions per week, one hour each, and the treatment of group E consisted in a session for 90 minutes every two weeks, with daily home exercises. The control group (group C) did not receive any intervention.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients diagnosed with hemophilia A or B
* Patients with hemophilic arthropathy in one or both elbows

Exclusion Criteria:

* Patients with another medical diagnosis (eg, Von Willebrand's disease)
* Patients with presence of antibodies to FVIII or FIX (inhibitors)
* Patients who had a haemarthrosis of elbow during the study

Primary outcomes:
measure: Changes in Range of Motion of Elbow
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in the Circumference of Arm
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in Biceps Strength
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in the Pain Perception of Elbow
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Assessment of Radiological Joint Deterioration
timeFrame: Screening visit (pretreatment assessment)
Secondary outcomes:
measure: Characteristics of the Patients
timeFrame: Screening visit (pretreatment assessment)
measure: Frequency of Elbow Hemarthrosis
timeFrame: Screening visit (pretreatment assessment)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: RUBEN CUESTA-BARRIUSO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuesta-Barriuso R, Gomez-Conesa A, Lopez-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.