Manual Therapy in Haemophilic Arthropathy of the Knee

Not Applicable

Completed

• Conditions: Patients With Haemophilia
• Interventions: Other: Manual Therapy; Other: Educational Physiotherapy

• Registration Number: NCT02198014
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-10
• Status Verified: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-22
• Last Update Submitted: 2014-07-22
• Study First Posted: 2014-07-23
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Therapy group	Manual Therapy	We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.
Educational gruop	Educational Physiotherapy	This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception. Each educational session of 90 minute every two weeks, with exercises daily home

Primary Outcome Measures

Name	Time	Method
Changes in the range of movement (ROM)	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	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	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	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	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 Outcome Measures

Name	Time	Method
Subjects' physical characteristics	Screening visit (pretreatment assessment)	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).
Changes in the frequency of knee hemarthrosis	Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)	Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.

Trial Locations

Locations (1)

Universidad de Murcia; 🇪🇸 Murcia, Spain