Manual Therapy in Haemophilic Arthropathy of the Knee

Patients With Haemophilia Clinical Trial

— ARTHROPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198014
• Other study ID #: ARTHROPATHY
• Secondary ID: ARTHROPAT
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: July 22, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hemophilia A
• Joint Diseases
• Patients With Haemophilia

Intervention

Other:
• Manual Therapy
5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension. 10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle. 10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension. 10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization. 10 minutes. Local cryotherapy with ice pack.
• Educational Physiotherapy
Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits. Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the range of movement (ROM)	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.	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Primary	Changes in quadriceps muscle circumference	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	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Primary	Changes in muscle strength of quadriceps	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).	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Primary	Changes in the perception of pain	Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Primary	Changes in the assessment of radiological joint deterioration	We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Secondary	Subjects' physical characteristics	Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).	Screening visit (pretreatment assessment)
Secondary	Changes in the frequency of knee hemarthrosis	Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)