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

NCT05057871 | Completed

• 1 other identifier: SUBIMPPEMF2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain; Musculoskeletal Diseases; Subacromial Impingement Syndrome; Shoulder Injuries and Disorders

Keywords

Pulse Electromagnetic Field Therapy; Subacromial Impingement Syndrome; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline visual analog scale (VAS) shoulder pain rest movement at 4th and 12th week

  Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

  up to 12th week

Secondary Outcomes (5)

• Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks

  up to 12th week

• range of motion

  up to 12th week

• Change from baseline Constant Murley Score (C-MS) at 4th and 12th weeks

  up to 12th week

• Change from baseline Shoulder Pain and Disability Index(SPADI) at 4th and 12th weeks

  up to 12th week

• Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks

  up to 12th week

Study Arms (2)

PEMF+exercise

EXPERIMENTAL

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.

Device: Pulse electromagnetic field therapy

Sham PEMF+exercise

SHAM COMPARATOR

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.

Device: Sham pulse electromagnetic field therapy

Interventions

Pulse electromagnetic field therapy DEVICE

It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 50 Hz frequency, 85 Gauss (8.5 milliTesla) intensity and for 30 minutes. The treatment period was 5 days a week for 4 weeks, in total. It was applied as 20 sessions. Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

PEMF+exercise

Sham pulse electromagnetic field therapy DEVICE

Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 20 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device. Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Sham PEMF+exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Inflammatory rheumatologic diseases
• Malignity
• Having received physical therapy and rehabilitation for the shoulder area in the last 3 months
• Local injection therapy to the shoulder area in the last 6 months
• History of trauma, history of surgery, history of fracture in the aching shoulder region in the last 6 months
• 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
• cervical radiculopathy
• Cervical myofascial pain syndrome
• cardiac pacemaker
• bleeding diathesis
• Body implant with electronic or battery system
• Acute infections
• tuberculosis

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (5)

• Michener LA, Walsworth MK, Burnet EN. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):152-64. doi: 10.1197/j.jht.2004.02.004.

  PMID: 15162102 BACKGROUND

• 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 BACKGROUND

• Guo L, Kubat NJ, Isenberg RA. Pulsed radio frequency energy (PRFE) use in human medical applications. Electromagn Biol Med. 2011 Mar;30(1):21-45. doi: 10.3109/15368378.2011.566775.

  PMID: 21554100 BACKGROUND

• Pribicevic M, Pollard H, Bonello R, de Luca K. A systematic review of manipulative therapy for the treatment of shoulder pain. J Manipulative Physiol Ther. 2010 Nov-Dec;33(9):679-89. doi: 10.1016/j.jmpt.2010.08.019. Epub 2010 Oct 18.

  PMID: 21109059 BACKGROUND

• Kandemir O, Adar S, Dundar U, Toktas H, Yesil H, Eroglu S, Eyvaz N. Effectiveness of Pulse Electromagnetic Field Therapy in Patients With Subacromial Impingement Syndrome: A Double-Blind Randomized Sham Controlled Study. Arch Phys Med Rehabil. 2024 Feb;105(2):199-207. doi: 10.1016/j.apmr.2023.09.020. Epub 2023 Oct 31.

  PMID: 37820844 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Musculoskeletal Diseases; Shoulder Impingement Syndrome; Shoulder Injuries; Disease

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Pathologic Processes

Study Officials

• Sevda MD ADAR

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Oğuzhan MD KANDEMİR

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 27, 2021
• Study Start: January 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)