Shoulder Impingement SyndromeNCT02735967
The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome
A study testing manual therapy and diadynamic current in people with Shoulder Impingement Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure. 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?
- manual therapy and diadynamic current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Jun 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 anterior lateral and unilateral shoulder pain
- with more than 3 months duration
- intensity of at least 4 points on the Numerical Rating Pain Scale
- positivity in at least 2 of 3 orthopedic tests for impingement syndrome: Neer, Hawkins or Jobe
- Associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder
Who cannot join
- diagnosis of bilateral impingement syndrome shoulder
- fibromyalgia
- muscle injury
- history of trauma on the shoulder
- ruptured tendons
- ligamentous laxity
Show all 10Show fewer
- symptoms of numbness and / or tingling in the upper limbs
- corticosteroid injection use shoulder
- making use of anti-inflammatory
- they performed surgery or physical therapy treatment in the last 6 months in the affected shoulder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome: a Randomized Blind Clinical Trial
The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- manual therapy, diadynamic current
- 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.
manual therapyOther
the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.
diadynamic currentDevice
Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.
| Study group | Role | What they receive |
|---|---|---|
| Group manual therapy + diadynamic | Experimental | Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.
Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient. Receives: Other: manual therapy; Device: diadynamic current |
| Group manual therapy | Active comparator | Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications. Receives: Other: manual therapy |
| Group diadynamic | Active comparator | An electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF),4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient. Receives: Device: diadynamic current |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder disability
questionnaire of quality of life developed to assess pain and associated with specific inability to shoulder disorders.
Measured: Change from Baseline in the Shoulder Pain and Disability Index at 4 weeks
Secondary outcomes (2)
intensity of pain
the Numerical rating pain scale, a simple, easily administered scale evaluates
Measured: Change from Baseline in The Numerical rating pain scale at 4 weeks
level of pressure pain
Pressure Pain Threshold in the shoulder with algometer dynamometer.
Measured: change from Baseline in ThePressure Pain Threshold at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionJun 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
- Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT02735967
- Sponsor's protocol ID
- 50917515.3.0000.5511
- Status last verified
- Jul 2016
- First submitted
- 2 Apr 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome: a Randomized Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02735967
- Acronym / sponsor ID
- 50917515.3.0000.5511
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Apr 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.
The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group manual therapy + diadynamic | Experimental | Other: manual therapy, Device: diadynamic currentInitially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications. Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient. |
| Group manual therapy | Active comparator | Other: manual therapyInitially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications. |
| Group diadynamic | Active comparator | Device: diadynamic currentAn electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF),4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- history of anterior lateral and unilateral shoulder pain
- with more than 3 months duration
- intensity of at least 4 points on the Numerical Rating Pain Scale
- positivity in at least 2 of 3 orthopedic tests for impingement syndrome: Neer, Hawkins or Jobe
- Associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder
Key exclusion criteria (10 listed)
- diagnosis of bilateral impingement syndrome shoulder
- fibromyalgia
- muscle injury
- history of trauma on the shoulder
- ruptured tendons
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 |
|---|---|---|
| manual therapythe positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications. | Other | Group manual therapy, Group manual therapy + diadynamic |
| diadynamic currentThrough an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient. | Device | Group diadynamic, Group manual therapy + diadynamic |
Primary outcome
shoulder disability
Time frame: Change from Baseline in the Shoulder Pain and Disability Index at 4 weeks
questionnaire of quality of life developed to assess pain and associated with specific inability to shoulder disorders.
2 secondary outcomes
intensity of pain
Time frame: Change from Baseline in The Numerical rating pain scale at 4 weeks
level of pressure pain
Time frame: change from Baseline in ThePressure Pain Threshold at 4 weeks
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 20 Jul 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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 manual therapy and diadynamic current 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 5 inclusion and 10 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 20 Jul 2016. 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?
shoulder disability (time frame: Change from Baseline in the Shoulder Pain and Disability Index at 4 weeks). 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 20 Jul 2016.