Physiotherapy in the Haemophilic Arthropathy of the Elbow.

NCT02198040 | Completed Results

• 1 other identifier: ELBOW
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation (PNF), and the other with education sessions and home exercises, for the improvement of the ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of the elbow.

Conditions

Patients With Hemophilia

Keywords

Elbow; Joint disease; Hemophilia; Physiotherapy modalities

Outcome Measures

Primary Outcomes (5)

• Changes in Range of Motion of Elbow

  Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.

  Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

• Changes in the Circumference of Arm

  Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.

  Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

• Changes in Biceps Strength

  Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates 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 Pain Perception of Elbow

  Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).

  Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)

• Assessment of Radiological Joint Deterioration

  Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)

  Screening visit (pretreatment assessment)

Secondary Outcomes (2)

• Characteristics of the Patients

  Screening visit (pretreatment assessment)

• Frequency of Elbow Hemarthrosis

  Screening visit (pretreatment assessment)

Study Arms (3)

Manual Therapy group

EXPERIMENTAL

The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation

Other: Manual Therapy

Educational group

EXPERIMENTAL

The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.

Other: Educational group

Control group

NO INTERVENTION

The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.

Interventions

Manual Therapy OTHER

* 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w. * 15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow. * 15 minutes. Passive muscle stretching (within the limits of mobility). * 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder. * 10 minutes. Local cryotherapy with ice bag and protection between it and the skin

Manual Therapy group

Educational group OTHER

* Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits. * Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.

Educational group

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 over 18 years
• Patients diagnosed with hemophilia A or B
• Patients with hemophilic arthropathy in one or both elbows

You may not qualify if:

• Patients with another medical diagnosis (eg, Von Willebrand's disease)
• Patients with presence of antibodies to FVIII or FIX (inhibitors)
• Patients who had a haemarthrosis of elbow during the study

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad de Murcia

Murcia, 30100, Spain

Location

Related Publications (1)

• Cuesta-Barriuso R, Gomez-Conesa A, Lopez-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.

  PMID: 30176883 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

Limitations and Caveats

A limitation of our study is the low sample size (n = 27), although 96% of paients who met the inclusion criteria participated Due to the randomization of subjects there was no division proportionate according to the severity of haemophilia

Results Point of Contact

• Title: Rubén Cuesta-Barriuso, PhD
• Organization: Universidad de Murcia

ruben.cuestab@gmail.com

+34 913146508

Study Officials

• RUBEN CUESTA-BARRIUSO, PhD

  Universidad Católica San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 1, 2018
• Results First Posted: February 23, 2017

Record last verified: 2016-12

Locations

ES (1)