Clinical trial NCT02198014: Manual Therapy in Haemophilic Arthropathy of the Knee
Official title: Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Haemophilia
Keywords: Knee
Joint disease
Haemophilia
Physiotherapy modalities
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 21
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: This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.

Detailed description: Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).

The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.

Eligibility criteria: Inclusion Criteria:

* Patients must be over the age of 18 years
* Diagnosis of haemophilia A or B
* Patients with haemophilic arthropathy in one or both knees

Exclusion Criteria:

* Patients who had a haemarthrosis of knee during intervention
* Patients with different medical diagnosis (eg, Von Willebrand's disease)
* Patients with antibodies to FVIII or FIX (inhibitors).

Primary outcomes:
measure: Changes in the range of movement (ROM)
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in quadriceps muscle circumference
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in muscle strength of quadriceps
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in the perception of pain
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
measure: Changes in the assessment of radiological joint deterioration
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Secondary outcomes:
measure: Subjects' physical characteristics
timeFrame: Screening visit (pretreatment assessment)
measure: Changes in the frequency of knee hemarthrosis
timeFrame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
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, Torres-Ortuno A, Nieto-Munuera J, Lopez-Pina JA. Effectiveness of an Educational Physiotherapy and Therapeutic Exercise Program in Adult Patients With Hemophilia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):841-848. doi: 10.1016/j.apmr.2016.10.014. Epub 2016 Nov 16.