Manual Therapy in Haemophilic Arthropathy of the Knee

NCT02198014 | Completed

• 2 other identifiers: ARTHROPATHYARTHROPAT
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Haemophilia

Keywords

Knee; Joint disease; Haemophilia; Physiotherapy modalities

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• 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 Arms (3)

Manual Therapy group

EXPERIMENTAL

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.

Other: Manual Therapy

Educational gruop

EXPERIMENTAL

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

Other: Educational Physiotherapy

Control group

NO INTERVENTION

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.

Interventions

Manual Therapy 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.

Manual Therapy group

Educational Physiotherapy 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.

Educational gruop

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be over the age of 18 years
• Diagnosis of haemophilia A or B
• Patients with haemophilic arthropathy in one or both knees

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad de Murcia

Murcia, Murcia, 30100, Spain

Location

Related Publications (1)

• 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.

  PMID: 27865846 DERIVED

MeSH Terms

Conditions

Joint Diseases; Hemophilia A

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• RUBEN CUESTA-BARRIUSO, PhD

  Universidad Católica San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-06

Locations

ES (1)