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Manual Therapy in Haemophilic Arthropathy of the Knee (ARTHROPA)

Primary Purpose

Patients With Haemophilia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Educational Physiotherapy
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Haemophilia focused on measuring Knee, Joint disease, Haemophilia, Physiotherapy modalities

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Universidad de Murcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Manual Therapy group

Educational gruop

Control group

Arm Description

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.

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

The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.

Outcomes

Primary Outcome Measures

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.
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
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).
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).
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).

Secondary Outcome Measures

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).
Changes in the frequency of knee hemarthrosis
Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.

Full Information

First Posted
July 21, 2014
Last Updated
July 22, 2014
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT02198014
Brief Title
Manual Therapy in Haemophilic Arthropathy of the Knee
Acronym
ARTHROPA
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Haemophilia
Keywords
Knee, Joint disease, Haemophilia, Physiotherapy modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational gruop
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the range of movement (ROM)
Description
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.
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in quadriceps muscle circumference
Description
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
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in muscle strength of quadriceps
Description
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).
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in the perception of pain
Description
Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in the assessment of radiological joint deterioration
Description
We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Secondary Outcome Measure Information:
Title
Subjects' physical characteristics
Description
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).
Time Frame
Screening visit (pretreatment assessment)
Title
Changes in the frequency of knee hemarthrosis
Description
Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUBEN CUESTA-BARRIUSO, PhD
Organizational Affiliation
Universidad Católica San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Murcia
City
Murcia
ZIP/Postal Code
30100
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27865846
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.
Results Reference
derived

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Manual Therapy in Haemophilic Arthropathy of the Knee

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