Physiotherapy in the Haemophilic Arthropathy of the Elbow.

NCT ID: NCT02198040

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

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.

Detailed Description

The intervention was carried out during twelve weeks, performing evaluations before and after treatment, and six months of finalizing this. The treatment of MT group consisted of two sessions per week, one hour each, and the treatment of group E consisted in a session for 90 minutes every two weeks, with daily home exercises. The control group (group C) did not receive any intervention.

Conditions

Patients With Hemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy group

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

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: 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

Educational group

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.

Group Type: EXPERIMENTAL

Educational group

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Manual Therapy

• 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

Intervention Type: OTHER

Educational group

• 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Rubén Cuesta-Barriuso, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RUBEN CUESTA-BARRIUSO, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio

Locations

Universidad de Murcia

Murcia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30176883 (View on PubMed)

Other Identifiers

ELBOW

Identifier Type: -

Identifier Source: secondary_id

ELBOW

Identifier Type: -

Identifier Source: org_study_id