Pulsed Electromagnetic Field (PEMF) in Impingement Shoulder
Condition: Impingement Shoulder
Study type: Interventional

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. 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.
    

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.
    

Intervention name(s): Pulsed Electromagnetical Field and Exercise
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): PEMF; Pulsed Electromagnetical Field; Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PEMF; magneto; shoulder; impingement