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临床试验/NCT05057871
NCT05057871已完成不适用

Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Subacromial Impingement Syndrome: A Randomized Study of Double Blınd With Sham Control

Afyonkarahisar Health Sciences University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Change from baseline visual analog scale (VAS) shoulder pain rest movement at 4th and 12th week

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Inflammatory rheumatologic diseases
  • 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

结局指标

主要结局

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

时间窗: up to 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.

次要结局

  • range of motion(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)
  • Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks(up to 12th week)
  • Change from baseline Constant Murley Score (C-MS) at 4th and 12th weeks(up to 12th week)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oğuzhan Kandemir

Research Assistant Doctor

Afyonkarahisar Health Sciences University

研究点 (2)

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