Pulsed Electromagnetic Field (PEMF) in Impingement Shoulder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Diego Galace de Freitas, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT01452204
First received: September 19, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.

Condition Intervention Phase
Impingement Shoulder
Other: Pulsed Electromagnetical Field and Exercise
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Electromagnetic Field in Patients With Impingement Shoulder: A Randomized, Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • Rotator cuff muscle force [ Time Frame: 3 weeks after exercise ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rotator cuff muscle force [ Time Frame: 3 months post-exercise follow up ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulsed Electromagnetical Field Other: Pulsed Electromagnetical Field and 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.
Other Names:
  • PEMF
  • Pulsed Electromagnetical Field
  • Exercise
Placebo Comparator: Placebo Other: Pulsed Electromagnetical Field and 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.
Other Names:
  • PEMF
  • Pulsed Electromagnetical Field
  • Exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. The patient must be aged between 30 and 50 years, of both sexes.
  3. Patients should not use any anti-inflammatory, analgesic and / or chondroprotective by at least one week before the start of treatment.
  4. The patient must not have been subjected to intra-articular injection of corticosteroids for at least 30 days before the start of treatment.
  5. The patient can not be being subjected to physical therapy for at least 30 days before the start of treatment.
  6. Patient must have at least 3 months of discomfort and / or symptoms of impingement syndrome.

Exclusion Criteria:

  1. Make use of systemic anti-inflammatory medications and / or topics during the study.
  2. Patient presenting during pregnancy or postpartum.
  3. A patient with cancer, even if you are treated.
  4. Having been subjected to surgery on the shoulder to receive the study treatment
  5. submit inflammatory joint diseases (such as rheumatoid arthritis, lupus, gout, etc.) except for the impingement of the rotator cuff.
  6. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452204

Contacts
Contact: Thiago TF Fukuda 551177330607 tfukuda10@yahoo.com.br

Locations
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo Recruiting
são Paulo, SP, Brazil, 01221-020
Contact: Nilza Carvalho, PhD    +55 11 2176-7000    fisioterapia@santacasasp.org   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: Diego DG Galace, Study Chair Faculdade de Ciências Médicas da Santa Casa de São Paulo
  More Information

No publications provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diego Galace de Freitas, MSc Student Diego Freitas, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT01452204     History of Changes
Other Study ID Numbers: PEMF01
Study First Received: September 19, 2011
Last Updated: October 13, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
PEMF
magneto
shoulder
impingement

ClinicalTrials.gov processed this record on October 29, 2014