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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Brazil

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:

  1. Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
  2. 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;
  3. Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
  4. Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
  5. 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
  1. 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.
  2. 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.
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 groups in NCT01452204
Study groupRoleWhat they receive
Pulsed Electromagnetical FieldExperimentalNot described
Receives: Other: Pulsed Electromagnetical Field and Exercise
PlaceboPlacebo comparatorNot 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.

  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 measurement of rotator cuff muscle force after 3 weeks of exercise treatment.

    Measured: 3 weeks after exercise

Secondary outcomes (1)
  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.

  1. First posted14 Oct 2011 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2011
  4. Study completionMar 2012

Resources

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)
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

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.

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