Immediate Effects of Superficial Heat Associated With Elongation in the Posttraumatic Elbow Contracture

April 27, 2019 updated by: Marisa de Cassia Registro Fonseca, University of Sao Paulo

Immediate Effects of Superficial Heat Associated With Sustained Stretching on Post-traumatic Elbow Contracture: a Randomized Clinical Trial

The elbow contracture is a secondary injury that can occur after direct trauma, causing the patient to have limitations in their range of motion. Objective evaluation protocols that help in decision making for the indication of these therapeutic resources have great value in rehabilitation, as they reduce unnecessary expenses and improve the assertiveness in the indication of this resource.

Objective: To verify the immediate effects of superficial heat associated with sustained stretching through muscle activity and range of motion in the posttraumatic contractures of the elbow seeking the best indication of orthosis.

Methods: Characterized as a randomized crossover type clinical trial. Sample of 20 adult subjects, of both sexes, over 18 years old, with elbow stiffness due to fractures and / or dislocations with indication of orthosis use. Patients will be divided into 2 randomly assigned intervention groups: the control group (CG) who will perform the 10 'sustained stretching drawn by a defined load through maximal voluntary isometric contraction (MVIC) and the modified Weeks Group (GWM) will perform 20 'of surface heat through the swirl and soon after the stretching sustained by 10' with already defined load. All patients will undergo an initial assessment and will participate in all 2 interventions while respecting a 7 day washout period. Goniometry and the visual analogue scale will be applied at the beginning and end of the interventions. The Delsys® brand equipment will be used to collect the electromyographic data. Placement and positioning of the electrodes will follow the determinations of the Seniam protocol. The activation of the brachial, brachioradial and triceps brachii muscles during the MVIC will be analyzed and also during the respective intervention protocols.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

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

    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048900
        • Lucy Montoro Institute of Rehabilitation

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • patients between the ages of 18 and 60
  • of both sexes
  • who present elbow stiffness with flexural contractures resulting from fractures and / or dislocations,
  • who are in the stages of fibroblastic healing and remodeling
  • will be selected, with indication of use of bracing for gain of range of motion
  • whether or not undergoing rehabilitation either after conservative or surgical orthopedic treatment

Exclusion:

  • Individuals who have clinical or surgical restrictions to perform activities of daily living
  • therapeutic exercises or use of orthoses
  • who have lesions in the central nervous system
  • open lesions
  • moderate to high intensity pain to sustained passive stretching

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group (GC)
The control group (GC) that will perform the 10 'sustained stretching tractioned by a load proportional to the force captured during a maximal voluntary isometric contraction (MVIC)
Patients underwent electromyographic analysis for the determination of maximal voluntary isometric contraction. The force will be collected for 5 seconds during a CIVM, in which a load cell model MM50 (Kratos, Cotia, SP, Brazil) will be positioned between the floor and the forearm of the volunteer, being coupled to a leather device at 20 cm Make the lateral epicondyle of the elbow. The angle between the forearm and the cable containing a load cell with a 90 degree service.
The control group will be applied to sustained stretching, patients will be placed in the supine position with abduction of the shoulder of 30 ° in the plane of the scapula and the forearm in neutral throughout the entire test and the elbow will be supported in a towel to avoid discomfort And compression in the region of the olecranon.
ACTIVE_COMPARATOR: GWM
The modified Weeks Group (GWM) that will carry out the modified Weeks protocol
Patients underwent electromyographic analysis for the determination of maximal voluntary isometric contraction. The force will be collected for 5 seconds during a CIVM, in which a load cell model MM50 (Kratos, Cotia, SP, Brazil) will be positioned between the floor and the forearm of the volunteer, being coupled to a leather device at 20 cm Make the lateral epicondyle of the elbow. The angle between the forearm and the cable containing a load cell with a 90 degree service.
The modified Weeks group (GWM) will apply the protocol suggested by Flowers (2002), the positioning will be maintained and at rest will be done electromyographic registers, active goniometry and EVA. Soon afterwards the patients will be submitted to the whirlwind for 20 minutes at a temperature of 41 ° C performing active flexion and elbow extension movements. After the swirl the patients will be submitted to a stretching maintained for 10 minutes with load proportional to the force captured during MVIC according to the pain of the patient. The load will be positioned through a leather device 20 cm from the lateral epicondyle of the elbow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion of elboww
Time Frame: 10 minutes
Goniometry of maximal elbow extension (degrees)
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyography
Time Frame: 10 minutes
Electromyographic activity of the agonist and elbow antagonist muscles
10 minutes

Collaborators and Investigators

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

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)

June 30, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

March 30, 2019

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (ACTUAL)

June 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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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