Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint

March 12, 2020 updated by: Ayse Merve Tat, Necmettin Erbakan University

Investigation of Effectiveness of Manual Therapy and Strengthening Exercises in Physiotherapy and Rehabilitation of Hemophilic Arthropathy of the Elbow

Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. Seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. The individuals were divided into the two groups via simple randomisation as Manuel Therapy and Exercise Group (MTEG) and Home Exercise Group (HEG). The individuals in HEG were given strengthening exercises as a home program. Those in the MTEG were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. All treatments were performed 3 times a week for 5 weeks totally 15 sessions. Frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. Numerical Pain Scale was used for activity and resting pain. Range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. The Quick-DASH questionnaire and Oxford Elbow Score were used for the functionality of the upper extremity and quality of life, respectively. The joint health status was evaluated with Hemophilia Joint Health Score-Elbow Point and Hospital for Special Surgery-Elbow Scoring System. Evaluations were made by the same physiotherapist before and after treatment.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sarıcam
      • Adana, Sarıcam, Turkey
        • Çukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.

Exclusion Criteria:

  • Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual therapy and strengthening exercises
Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist.
Other: Manual therapy
Manual therapy includes techniques applied to elbow joints and surrounding tissues
Other: Strengthening exercises
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity
ACTIVE_COMPARATOR: Strengthening exercises
Patients in this group performed the strengthening exercises given to the experimental group on their own at home with experimental group at the same time, frequency and dose.
Other: Strengthening exercises
Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemophilia Joint Health Score
Time Frame: 5 week
We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen
5 week
Frequency of bleeding
Time Frame: 5 week
It was evaluated wit bleeding number in elbow joint over last 5 week
5 week
Numerical Pain Scale
Time Frame: 5 week
It was used for evaluation of activity and resting pain.
5 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 5 week
It was measured with universal goniometer.
5 week
Muscle strength
Time Frame: 5 week
It was measured with digital dynamometer (Lafayette hand-held dynamometer)
5 week
Functionality of the upper extremity
Time Frame: 5 week
Quick-Disability of Arm, Shoulder and Hand questionnaire was used.
5 week
Oxford Elbow Score
Time Frame: 5 week
It was used for evaluation of Quality of life.
5 week
Physical status of the elbow
Time Frame: 5 week
Hospital for Special Surgery-Elbow Scoring System was used.
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Study Chair: Filiz Can, Professor, Hacettepe University, Faculty of Physical Therapy
  • Study Director: Ilgen Sasmaz, Cukurova University, Faculty of Medicine, Department of Pediatric Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2018

Primary Completion (ACTUAL)

March 10, 2019

Study Completion (ACTUAL)

February 6, 2020

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Necmettin Erb. Physiotherapy-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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