Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.

January 15, 2017 updated by: Cid André Fidelis de Paula Gomes, University of Nove de Julho
This project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. Sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation of pain at the end of Each session and one month after the end of treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • São Paulo
      • Sao Paulo, São Paulo, Brazil
        • University of Nove de Julho

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of anterolateral, unilateral pain in the shoulder with more than 3 months duration.
  • Medical diagnosis,
  • minimal grade 4 pain by numerical scale of pain assessment,
  • positivity in at least 2 of 3 orthopedic tests for impact syndrome: Neer, Hawkins or Jobe.

Exclusion Criteria:

  • Fibromyalgia diagnosis,
  • pregnancy,
  • numbness or tingling in the upper limb
  • History of shoulder trauma, other shoulder related diseases,
  • ruptured tendons, ligament laxity,
  • symptoms of numbness and / or Tingling in the upper limbs, history of shoulder and / or cervical surgery
  • use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: exercise group
Manual cervical traction, Myofascial release of upper trapezius muscle, 3 sets of 1 minute;Sleeper's stretch, during 3 series of 30 seconds,Punch exercise, Knee push-up plus, Prone V-raise exercise (arms abducted at 120°), rotador cuff exercise (internal rotation), rotador cuff exercise (external rotation), Rotation on the wall using a ball (internal rotation), Rotation on the wall using a ball (external rotation).
Other: exercise
Experimental: exercise + Interferential current group
Addition to the exercise protocol performed in the exercise group the interferential current. Four self-adhesive electrodes (8x5 cm), two upper and two lower ones (forming a square) will be placed around the center of the shoulder. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (swing pattern), 100 Hz Frequency modulation amplitude (AMF), 50 Hz (sweep frequency), automatic vector mode, With intensity at the motor threshold of sensation, with duration of 50 minutes.
Other: exercise
Device: Interferential current therapy
Placebo Comparator: exercise + US group
In addition to the exercise protocol performed in the exercise group, an ultrasound device will be used. The appliance will be used off, without any individual participant having knowledge. For this, the individual will be asked to position himself in the dorsal position on the stretcher, the therapist will perform the application of the transducer head, with gel on its surface, in the anterolateral region of the affected shoulder.
Other: exercise
Device: Therapeutic Ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
physical function and pain
Time Frame: 10 months
The Shoulder pain and disability index in the numerical version consists of 13 items distributed in the domain of pain (five items) and function (eight items), each item being scored on a numerical rating scale of 0 to 10 points. The final score of the questionnaire, as well as the score obtained separately by each domain, is converted into a percentage for values ranging from 0 to 100, with the highest score indicating worse shoulder dysfunction condition.
10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 10 months
Numeric pain rating scale
10 months
Catastrophizing of the Pain
Time Frame: 10 months
Pain-Related Catastrophizing Thoughts Scale
10 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 51675615.3.0000.5511

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