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Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome

A

Afyonkarahisar Health Sciences University

Status

Completed

Conditions

Shoulder Pain
Musculoskeletal Diseases
Shoulder Injuries and Disorders
Subacromial Impingement Syndrome

Treatments

Device: Sham pulse electromagnetic field therapy
Device: Pulse electromagnetic field therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05057871
SUBIMPPEMF2021

Details and patient eligibility

About

The aim of our study is to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMT) versus placebo on pain, quality of life, shoulder function and isokinetic assessment, and muscle strength in the treatment of subacromial impingement syndrome.

Full description

Shoulder pain is one of the common health problems. It ranks third among musculoskeletal problems after low back and neck pain. Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain. SIS is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial-subdeltoid bursa, and biceps tendon located under the acromion and coracoacromial ligament. SIS is characterized by functional limitation of the shoulder with gradual limitation of both active and passive glenohumeral movement due to compression of the subacromial structures. Pain in the anterior shoulder region, which is exacerbated by elevation of the shoulder joint or overhead activities, and limitation of range of motion are the main reasons for the decrease in quality of life in patients with SIS.

The most common symptom of SIS is pain. The pain is usually at night and radiates to the anterior aspect of the shoulder. Night pain often occurs when lying on the affected side and is typically in the deltoid region. Symptoms usually increase with abduction, elevation, or overhead activities. Patients often complain that they have difficulty reaching their back while dressing. Active movements may be restricted due to pain.

Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs), steroid injections, physical therapy methods, exercise and surgical procedures are used in the treatment of shoulder pain. Superficial hot and cold applications, analgesic currents, ultrasound, extracorporeal shock wave therapy (ESWT), magnetotherapy, laser and acupuncture are preferred as treatment options.

Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases.

This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 2 groups: PEMF + therapeutic exercise, sham PEMF + therapeutic exercise.

Shoulder range of motion, Visual Pain Scale (VAS), SF (Short form) -36 Quality of Life Scale, Constant Murley Scale, Shoulder pain and disability index, upper extremity muscle strength measurement with Isomed 2000 isokinetic device) will be evaluated. It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.

Enrollment

80 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Shoulder pain for at least 6 weeks in the 30-65 age range
  2. Positivity of shoulder impingement tests on examination(Neer test, Hawkins Kennedy test)
  3. Findings related to subacromial impingement syndrome in MRI

Exclusion criteria

  1. Pregnancy
  2. Inflammatory rheumatologic diseases
  3. Malignity
  4. Having received physical therapy and rehabilitation for the shoulder area in the last 3 months
  5. Local injection therapy to the shoulder area in the last 6 months
  6. History of trauma, history of surgery, history of fracture in the aching shoulder region in the last 6 months
  7. Adhesive capsulitis, calcification findings in the rotator cuff tendons exceeding 2 cm, findings of full-thickness total rotator cuff rupture in magnetic resonance (MR) imaging, presence of osteoarthritis findings and labral pathologies in imaging of the acromioclavicular joint or glenohumeral joint, presence of benign malignant lesions
  8. cervical radiculopathy
  9. Cervical myofascial pain syndrome
  10. cardiac pacemaker
  11. bleeding diathesis
  12. Body implant with electronic or battery system
  13. Acute infections
  14. tuberculosis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

PEMF+exercise
Experimental group
Description:
A total of 20 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia), five times a week and once a day for four weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist.
Treatment:
Device: Pulse electromagnetic field therapy
Sham PEMF+exercise
Sham Comparator group
Description:
Sham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist.
Treatment:
Device: Sham pulse electromagnetic field therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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