search
Back to results

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

Primary Purpose

Contracture of Elbow Joint

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Modified Weeks protocol
CIVM
GC- Sustained Stretching
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contracture of Elbow Joint focused on measuring Elbow, Stretching, Joint amplitude, Electromyography, Surface heat, Orthosis, Posttraumatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucy Montoro Institute of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group (GC)

GWM

Arm Description

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)

The modified Weeks Group (GWM) that will carry out the modified Weeks protocol

Outcomes

Primary Outcome Measures

Range of motion of elboww
Goniometry of maximal elbow extension (degrees)

Secondary Outcome Measures

Surface electromyography
Electromyographic activity of the agonist and elbow antagonist muscles

Full Information

First Posted
January 29, 2017
Last Updated
April 27, 2019
Sponsor
University of Sao Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT03179098
Brief Title
Immediate Effects of Superficial Heat Associated With Elongation in the Posttraumatic Elbow Contracture
Official Title
Immediate Effects of Superficial Heat Associated With Sustained Stretching on Post-traumatic Elbow Contracture: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contracture of Elbow Joint
Keywords
Elbow, Stretching, Joint amplitude, Electromyography, Surface heat, Orthosis, Posttraumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group (GC)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
GWM
Arm Type
Active Comparator
Arm Description
The modified Weeks Group (GWM) that will carry out the modified Weeks protocol
Intervention Type
Other
Intervention Name(s)
Modified Weeks protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CIVM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
GC- Sustained Stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of motion of elboww
Description
Goniometry of maximal elbow extension (degrees)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Surface electromyography
Description
Electromyographic activity of the agonist and elbow antagonist muscles
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lucy Montoro Institute of Rehabilitation
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048900
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs