Shoulder Pain Clinical Trial
Official title:
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome: A Randomized Study of Double Blınd With Sham Control
Verified date | November 2022 |
Source | Afyonkarahisar Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Afyonkarahisar Health Sciences University | Afyonkarahi?sar |
Lead Sponsor | Collaborator |
---|---|
Afyonkarahisar Health Sciences University |
Turkey,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks | This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health. | up to 12th week | |
Secondary | range of motion | In shoulder range of motion measurement, flexion and abduction will be recorded, including active and passive measurements of the shoulder with a goniometer.Shoulder internal and external rotation measurements will be recorded while the patient's shoulder is abducted at 90 degrees and the elbow is flexed at 90 degrees. | up to 12th week | |
Secondary | Change from baseline Constant Murley Score (C-MS) at 4th and 12th weeks | The Constant-Murley Shoulder Score (C-M Score) is a clinical and functional assessment scale that evaluates the functional status of a normal, diseased or treated shoulder. Comparisons can be made in pre-treatment and post-treatment follow-up. Evaluated parameters were pain (15 points), activities of daily living (20 points), ROM (40 points), and strength (25 points).Scoring that measures the functionality of the shoulder consists of 100 points in total. C-M score; It is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). | up to 12th week | |
Secondary | Change from baseline Shoulder Pain and Disability Index(SPADI) at 4th and 12th weeks | It is a two-part scale that evaluates pain and function.The first part questions pain, the second part questions disability. In the pain section consisting of 5 items, the pain felt during activities of daily living is measured using a 10-unit VAS, and in the disability section, the difficulty encountered during activities of daily living is measured in the 8-item disability section. The score of both sections and the total score are calculated with a special formula. | up to 12th week | |
Secondary | Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks | Isokinetic contraction; It is defined as contraction at a constant rate throughout the entire range of motion and at an equal rate at all angles of motion. No matter how hard a person moves the device, they can never exceed the predetermined speed (for example, 90 degrees per second). It is advantageous that the desired muscle or muscle groups can be evaluated in isolation and that the measurements are comparable. The isokinetic strength assessment of the patients during internal and external rotation of the shoulder will be made with an isokinetic device (IsoMed 2000, isokinetic dynamometer, Germany). Measurements will be made by a physiotherapist with at least 5 years of device experience. Measurements will be made in 10 repetitions to increase reliability. | up to 12th week |
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