Contracture of Elbow JointNCT03179098
Immediate Effects of Superficial Heat Associated With Elongation in the Posttraumatic Elbow Contracture
A study testing Modified Weeks protocol, CIVM and GC- Sustained Stretching in people with Contracture of Elbow Joint, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Contracture of Elbow Joint
- What is being tested?
- Modified Weeks protocol, CIVM and GC- Sustained Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2017to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lucy Montoro Institute of Rehabilitation
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: 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.
- Conditions
- Contracture of Elbow Joint
- Being tested
- Modified Weeks protocol, CIVM, GC- Sustained Stretching
- Keywords
- Elbow, Stretching, Joint amplitude, Electromyography, Surface heat, Orthosis, Posttraumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Weeks protocolOther
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.
CIVMOther
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.
GC- Sustained StretchingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (GC) | Active comparator | 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) Receives: Other: CIVM; Other: GC- Sustained Stretching |
| GWM | Active comparator | The modified Weeks Group (GWM) that will carry out the modified Weeks protocol Receives: Other: Modified Weeks protocol; Other: CIVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of elboww
Goniometry of maximal elbow extension (degrees)
Measured: 10 minutes
Secondary outcomes (1)
Surface electromyography
Electromyographic activity of the agonist and elbow antagonist muscles
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start30 Jun 2017
- Primary completion30 Jul 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contracture of Elbow JointStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marisa de Cassia Registro Fonseca, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179098
- Sponsor's protocol ID
- FMRPUSP2
- Status last verified
- Apr 2019
- First submitted
- 29 Jan 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Superficial Heat Associated With Sustained Stretching on Post-traumatic Elbow Contracture: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03179098
- Acronym / sponsor ID
- FMRPUSP2
- Conditions
- Contracture of Elbow Joint
- Keywords
- Elbow, Stretching, Joint amplitude, Electromyography, Surface heat, Orthosis, Posttraumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (GC) | Active comparator | Other: CIVM, Other: GC- Sustained StretchingThe 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) |
| GWM | Active comparator | Other: Modified Weeks protocol, Other: CIVMThe modified Weeks Group (GWM) that will carry out the modified Weeks protocol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Weeks protocolThe 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. | Other | GWM |
| CIVMPatients 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. | Other | Control group (GC), GWM |
| GC- Sustained StretchingThe 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. | Other | Control group (GC) |
Primary outcome
Range of motion of elboww
Time frame: 10 minutes
Goniometry of maximal elbow extension (degrees)
1 secondary outcome
Surface electromyography
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Weeks protocol, CIVM and GC- Sustained Stretching in people with Contracture of Elbow Joint, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of elboww (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.