Shoulder Impingement SyndromeNCT02964819
Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.
A study testing exercise, Interferential current therapy and Therapeutic Ultrasound in people with Shoulder Impingement Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- exercise, Interferential current therapy and Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Dec 2016
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- exercise, Interferential current therapy, Therapeutic Ultrasound
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Interferential current therapyDevice
Therapeutic UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Active comparator | 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). Receives: Other: exercise |
| exercise + Interferential current group | Experimental | 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. Receives: Other: exercise; Device: Interferential current therapy |
| exercise + US group | Placebo comparator | 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. Receives: Other: exercise; Device: Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function and pain
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.
Measured: 10 months
Secondary outcomes (2)
pain
Numeric pain rating scale
Measured: 10 months
Catastrophizing of the Pain
Pain-Related Catastrophizing Thoughts Scale
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964819
- Sponsor's protocol ID
- 51675615.3.0000.5511
- Status last verified
- Jan 2017
- First submitted
- 13 Nov 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02964819
- Acronym / sponsor ID
- 51675615.3.0000.5511
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise group | Active comparator | Other: exerciseManual 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). |
| exercise + Interferential current group | Experimental | Other: exercise, Device: Interferential current therapyAddition 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. |
| exercise + US group | Placebo comparator | Other: exercise, Device: Therapeutic UltrasoundIn 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Fibromyalgia diagnosis,
- pregnancy,
- numbness or tingling in the upper limb
- History of shoulder trauma, other shoulder related diseases,
- ruptured tendons, ligament laxity,
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 |
|---|---|---|
| exercise | Other | exercise + Interferential current group, exercise + US group, exercise group |
| Interferential current therapy | Device | exercise + Interferential current group |
| Therapeutic Ultrasound | Device | exercise + US group |
Primary outcome
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.
2 secondary outcomes
pain
Time frame: 10 months
Catastrophizing of the Pain
Time frame: 10 months
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 18 Jan 2017.
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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 exercise, Interferential current therapy and Therapeutic Ultrasound in people with Shoulder Impingement Syndrome, run by University of Nove de Julho 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 4 inclusion and 7 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 18 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
physical function and pain (time frame: 10 months). 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 18 Jan 2017.