Manual Therapy in Haemophilic Arthropathy of the Knee

NCT ID: NCT02198014

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Patients With Haemophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Manual Therapy group

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.

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type OTHER

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 gruop

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

Group Type EXPERIMENTAL

Educational Physiotherapy

Intervention Type OTHER

* 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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RUBÉN CUESTA-BARRIUSO

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RUBEN CUESTA-BARRIUSO, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio

Locations

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Universidad de Murcia

Murcia, Murcia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 27865846 (View on PubMed)

Other Identifiers

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ARTHROPAT

Identifier Type: -

Identifier Source: secondary_id

ARTHROPATHY

Identifier Type: -

Identifier Source: org_study_id

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