Impingement ShoulderPEMFNCT01452204
Pulsed Electromagnetic Field (PEMF) in Impingement Shoulder
A study testing Pulsed Electromagnetical Field and Exercise in people with Impingement Shoulder, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
In the past many authors have reported the abnormal contact between the rotator cuff and coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives of this study relate specifically to improve the symptoms and rehabilitation of shoulder function of the patient: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Shoulder
- What is being tested?
- Pulsed Electromagnetical Field and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Mar 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must have a diagnosis of impingement of the rotator cuff grade II or grade III. For patients with grade III, they must present at least 90 ° of active elevation of the affected shoulder-free. Patients with extensive lesions of the rotator cuff will be deleted.
- The patient must be aged between 30 and 50 years, of both sexes.
- Patients should not use any anti-inflammatory, analgesic and / or chondroprotective by at least one week before the start of treatment.
- The patient must not have been subjected to intra-articular injection of corticosteroids for at least 30 days before the start of treatment.
- The patient can not be being subjected to physical therapy for at least 30 days before the start of treatment.
- Patient must have at least 3 months of discomfort and / or symptoms of impingement syndrome.
Who cannot join
- Make use of systemic anti-inflammatory medications and / or topics during the study.
- Patient presenting during pregnancy or postpartum.
- A patient with cancer, even if you are treated.
- Having been subjected to surgery on the shoulder to receive the study treatment
- submit inflammatory joint diseases (such as rheumatoid arthritis, lupus, gout, etc.) except for the impingement of the rotator cuff.
- Patients who do not submit high active-free up to 90 degrees (minimum) of the affected shoulder will be deleted. These cases are specific to patients with extensive lesions of the rotator cuff and have no function of this muscle group.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020
About this study
Official title: Pulsed Electromagnetic Field in Patients With Impingement Shoulder: A Randomized, Placebo-Controlled Clinical Trial
In the past many authors have reported the abnormal contact between the rotator cuff and coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives of this study relate specifically to improve the symptoms and rehabilitation of shoulder function of the patient:
- Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
- Assess whether the application of magnetic therapy 3 times a week for three weeks, may be effective as a single treatment of impingement of the rotator cuff;
- Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
- Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
- Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and 20 mT in patients with shoulder impingement syndrome.
Read the detailed description
- Randomization of the patients 1.1) Duration of wash-out Having made the proper screening of patients undergoing the study, all pre-selected patients should discontinue any medications that might influence the symptoms of impingement syndrome (such as analgesics, antiinflammatory, chondroprotective, etc.) for a period of 7 days. 1.2) Randomization The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome (IS). Patients will be equally distributed in two groups, receiving first place: Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session. Group 2: placebo of magnet therapy (MT), three times per week lasting 30 minutes each session. Randomization will be done as follows: initially 10 patients will be selected to be evaluated by a blinded evaluator and by the end of the evaluation, the patient will randomly choose a paper folded into 2 parts, which will be inside a plastic bag. Inside this bag there will be 10 paper folded in the same way and with the same color and size, where in three of them will say "A", two of them written in "B", three of them written in "C" and two of them "D" . Patients were drawn papers written "A" and "D" will be selected for group 1 and patients to raffle papers written "B" and "C" will be selected for group 2. After the drawing paper, the same can not be placed back in the bag. Randomization will be done this way so that all patients can also be divided into two groups and for the blind assessor does not know which group the patient was allocated.
- PLAN OF STUDY 2.1) Assessment 1: Patients selected for study are those referred to our outpatient musculoskeletal physiotherapy with a diagnosis of impingement syndrome grade II and grade III. All will be evaluated by a blinded investigator, who uses the Visual Analogue Scale (VAS), the rating scale of Constant and University of California, Los Angeles (UCLA) shoulder rating scale, and measurement of rotator cuff muscle force (external and internal rotation) and shoulder elevation.
2.2) Assessment 2: After 3 weeks of treatment only with the applications of magneto therapy, a new assessment will be equal to an evaluation made by an assessor blinded, who do not know which patients are exposed to placebo or not. After the third evaluation, all patients will continue with the sessions of magnetic therapy (placebo or not), but now associated with specific therapeutic exercises for the treatment of impingement syndrome of the shoulder. The assessment consists of two re-evaluation of all parameters previously in an evaluation.
2.3) Evaluation 3: The third evaluation will happen after three weeks of treatment with magnetic therapy and exercises over again a blind assessor will evaluate patients in the same manner as in evaluation 1 and 2. After this evaluation, patients receive high treatment and receive a booklet of exercises to help them to practice proper exercises for the shoulder at home.
2.4) Evaluation 4: The fourth review will occur six months after the third evaluation, where the main objective is to evaluate the efficacy of treatment without the guidance of a physiotherapist and without weekly applications of magnetic therapy.
- Application of methods: The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome. Patients will be equally distributed in two groups, receiving first place: Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session. Group 2: placebo of magnet therapy, three times per week lasting 30 minutes each session.After the first 3 weeks of application of magnetic therapy, will begin a program of therapeutic exercises (kinesiotherapy) equally to all patients in both groups. These exercises will be conducted after each application of magnetic therapy and all patients will receive a brochure guiding them to perform exercises at home. The applications of magnetic therapy will continue to be 3 times per week with 30 minutes duration each application, but this time associated with exercise, treatment will be done for another 4 weeks. After these four weeks, patients will be reassessed by the scale of Constant and UCLA to evaluate the overall function of the shoulders that received placebo treatment and the magneto.
- Conditions
- Impingement Shoulder
- Being tested
- Pulsed Electromagnetical Field and Exercise
- Keywords
- PEMF, magneto, shoulder, impingement
- 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.
Pulsed Electromagnetical Field and ExerciseOther
Also called PEMF, Pulsed Electromagnetical Field, Exercise
G1: MT, three times per week lasting 30' each session. G2: placebo MT, 3 X week lasting 30'each session. After 3 weeks of application of MT, will begin a program of exercises.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetical Field | Experimental | Not described Receives: Other: Pulsed Electromagnetical Field and Exercise |
| Placebo | Placebo comparator | Not described Receives: Other: Pulsed Electromagnetical Field and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff muscle force
Patients selected are those referred with a diagnosis of impingement syndrome grade II and III. All will be evaluated by a blinded investigator, who uses measurement of rotator cuff muscle force after 3 weeks of exercise treatment.
Measured: 3 weeks after exercise
Secondary outcomes (1)
Rotator cuff muscle force
Patients selected are those referred with a diagnosis of impingement syndrome grade II and III. All will be evaluated by a blinded investigator, who uses the measurement of rotator cuff muscle force
Measured: 3 months post-exercise follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impingement ShoulderStudies 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, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Galace de Freitas, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- Diego DG Galace, Study Chair, Principal investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452204
- Sponsor's protocol ID
- PEMF01
- Acronym
- PEMF
- Status last verified
- Oct 2011
- First submitted
- 19 Sep 2011
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria de Moraes Barros Fucs P, Fukuda TY. Pulsed electromagnetic field and exercises in patients with shoulder impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. Arch Phys Med Rehabil. 2014 Feb;95(2):345-52. doi: 10.1016/j.apmr.2013.09.022. Epub 2013 Oct 15.
PubMed 24139986
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Field in Patients With Impingement Shoulder: A Randomized, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01452204
- Acronym / sponsor ID
- PEMF / PEMF01
- Conditions
- Impingement Shoulder
- Keywords
- PEMF, magneto, shoulder, impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Oct 2011 (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.
In the past many authors have reported the abnormal contact between the rotator cuff and coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives of this study relate specifically to improve the symptoms and rehabilitation of shoulder function of the patient:
- Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
- Assess whether the application of magnetic therapy 3 times a week for three weeks, may be effective as a single treatment of impingement of the rotator cuff;
- Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
- Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
- Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and 20 mT in patients with shoulder impingement syndrome.
Detailed description
- Randomization of the patients 1.1) Duration of wash-out Having made the proper screening of patients undergoing the study, all pre-selected patients should discontinue any medications that might influence the symptoms of impingement syndrome (such as analgesics, antiinflammatory, chondroprotective, etc.) for a period of 7 days. 1.2) Randomization The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome (IS). Patients will be equally distributed in two groups, receiving first place: Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session. Group 2: placebo of magnet therapy (MT), three times per week lasting 30 minutes each session. Randomization will be done as follows: initially 10 patients will be selected to be evaluated by a blinded evaluator and by the end of the evaluation, the patient will randomly choose a paper folded into 2 parts, which will be inside a plastic bag. Inside this bag there will be 10 paper folded in the same way and with the same color and size, where in three of them will say "A", two of them written in "B", three of them written in "C" and two of them "D" . Patients were drawn papers written "A" and "D" will be selected for group 1 and patients to raffle papers written "B" and "C" will be selected for group 2. After the drawing paper, the same can not be placed back in the bag. Randomization will be done this way so that all patients can also be divided into two groups and for the blind assessor does not know which group the patient was allocated.
- PLAN OF STUDY 2.1) Assessment 1: Patients selected for study are those referred to our outpatient musculoskeletal physiotherapy with a diagnosis of impingement syndrome grade II and grade III. All will be evaluated by a blinded investigator, who uses the Visual Analogue Scale (VAS), the rating scale of Constant and University of California, Los Angeles (UCLA) shoulder rating scale, and measurement of rotator cuff muscle force (external and internal rotation) and shoulder elevation.
2.2) Assessment 2: After 3 weeks of treatment only with the applications of magneto therapy, a new assessment will be equal to an evaluation made by an assessor blinded, who do not know which patients are exposed to placebo or not. After the third evaluation, all patients will continue with the sessions of magnetic therapy (placebo or not), but now associated with specific therapeutic exercises for the treatment of impingement syndrome of the shoulder. The assessment consists of two re-evaluation of all parameters previously in an evaluation.
2.3) Evaluation 3: The third evaluation will happen after three weeks of treatment with magnetic therapy and exercises over again a blind assessor will evaluate patients in the same manner as in evaluation 1 and 2. After this evaluation, patients receive high treatment and receive a booklet of exercises to help them to practice proper exercises for the shoulder at home.
2.4) Evaluation 4: The fourth review will occur six months after the third evaluation, where the main objective is to evaluate the efficacy of treatment without the guidance of a physiotherapist and without weekly applications of magnetic therapy.
- Application of methods: The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome. Patients will be equally distributed in two groups, receiving first place: Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session. Group 2: placebo of magnet therapy, three times per week lasting 30 minutes each session.After the first 3 weeks of application of magnetic therapy, will begin a program of therapeutic exercises (kinesiotherapy) equally to all patients in both groups. These exercises will be conducted after each application of magnetic therapy and all patients will receive a brochure guiding them to perform exercises at home. The applications of magnetic therapy will continue to be 3 times per week with 30 minutes duration each application, but this time associated with exercise, treatment will be done for another 4 weeks. After these four weeks, patients will be reassessed by the scale of Constant and UCLA to evaluate the overall function of the shoulders that received placebo treatment and the magneto.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetical Field | Experimental | Other: Pulsed Electromagnetical Field and Exercise |
| Placebo | Placebo comparator | Other: Pulsed Electromagnetical Field and Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have a diagnosis of impingement of the rotator cuff grade II or grade III. For patients with grade III, they must present at least 90 ° of active elevation of the affected shoulder-free. Patients with extensive lesions of the rotator cuff will be deleted.
- The patient must be aged between 30 and 50 years, of both sexes.
- Patients should not use any anti-inflammatory, analgesic and / or chondroprotective by at least one week before the start of treatment.
- The patient must not have been subjected to intra-articular injection of corticosteroids for at least 30 days before the start of treatment.
- The patient can not be being subjected to physical therapy for at least 30 days before the start of treatment.
Key exclusion criteria (6 listed)
- Make use of systemic anti-inflammatory medications and / or topics during the study.
- Patient presenting during pregnancy or postpartum.
- A patient with cancer, even if you are treated.
- Having been subjected to surgery on the shoulder to receive the study treatment
- submit inflammatory joint diseases (such as rheumatoid arthritis, lupus, gout, etc.) except for the impingement of the rotator cuff.
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 |
|---|---|---|
| Pulsed Electromagnetical Field and ExerciseAlso: PEMF, Pulsed Electromagnetical Field, ExerciseG1: MT, three times per week lasting 30' each session. G2: placebo MT, 3 X week lasting 30'each session. After 3 weeks of application of MT, will begin a program of exercises. | Other | Placebo, Pulsed Electromagnetical Field |
Primary outcome
Rotator cuff muscle force
Time frame: 3 weeks after exercise
Patients selected are those referred with a diagnosis of impingement syndrome grade II and III. All will be evaluated by a blinded investigator, who uses measurement of rotator cuff muscle force after 3 weeks of exercise treatment.
1 secondary outcome
Rotator cuff muscle force
Time frame: 3 months post-exercise follow up
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 28 Mar 2017.
- Derived from this study: PubMed 24139986Galace de Freitas D, Marcondes FB, Monteiro RL, Rosa SG, Maria de Moraes Barros Fucs P, Fukuda TY. Pulsed electromagnetic field and exercises in patients with shoulder impingement syndrome: a randomized, double-blind, placebo-controlled clinical trial. Arch Phys Med Rehabil. 2014 Feb;95(2):345-52. doi: 10.1016/j.apmr.2013.09.022. Epub 2013 Oct 15.
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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.
Diego DG Galace, Study Chair principal investigator
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetical Field and Exercise in people with Impingement Shoulder, run by Faculdade de Ciências Médicas da Santa Casa de São 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 6 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 28 Mar 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?
Rotator cuff muscle force (time frame: 3 weeks after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452204, which also lists 1 linked publication.
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 28 Mar 2017.