Pulsed Electromagnetic Field (PEMF) in Impingement Shoulder

NCT01452204 | Completed

• 1 other identifier: PEMF01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
2. 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. 3.Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
4. 4.Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
5. 5.Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and 20 mT in patients with shoulder impingement syndrome.

Conditions

Impingement Shoulder

Keywords

PEMF; magneto; shoulder; impingement

Outcome Measures

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

  3 weeks after exercise

Secondary Outcomes (1)

• Rotator cuff muscle force

  3 months post-exercise follow up

Study Arms (2)

Pulsed Electromagnetical Field

EXPERIMENTAL

Other: Pulsed Electromagnetical Field and Exercise

Placebo

PLACEBO COMPARATOR

Other: Pulsed Electromagnetical Field and Exercise

Interventions

Pulsed Electromagnetical Field and Exercise OTHER

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.

Also known as: PEMF, Pulsed Electromagnetical Field, Exercise

Placebo; Pulsed Electromagnetical Field

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24139986 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diego DG Galace, Study Chair

  Faculdade de Ciências Médicas da Santa Casa de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student Diego Freitas

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: October 14, 2011
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 28, 2017

Record last verified: 2011-10

Locations

BR (1)