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Clinical Trials/NCT02198014
NCT02198014
Completed
Not Applicable

Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study

Universidad Católica San Antonio de Murcia1 site in 1 country21 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients With Haemophilia
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
21
Locations
1
Primary Endpoint
Changes in the range of movement (ROM)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

RUBÉN CUESTA-BARRIUSO

PhD

Universidad Católica San Antonio de Murcia

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).

Outcomes

Primary Outcomes

Changes in the range of movement (ROM)

Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.

Changes in muscle strength of quadriceps

Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).

Changes in quadriceps muscle circumference

Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure

Changes in the perception of pain

Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).

Changes in the assessment of radiological joint deterioration

Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).

Secondary Outcomes

  • Subjects' physical characteristics(Screening visit (pretreatment assessment))
  • Changes in the frequency of knee hemarthrosis(Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment))

Study Sites (1)

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