Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field (PBMT-sMF) on Temporary Pain Relief in Patients With Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Degree of Pain Rating (VAS)
研究概览
简要总结
Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle. LE can be considered an overuse injury which occurs on the lateral side of the elbow in the extensor tendons with repetitive micro-trauma. The clinical presentation of LE involves a painful or burning sensation over the humeral insertion of the common extensor tendons. Despite the high incidence of LE, optimal treatment has not been established. Treatment options include therapeutic exercise, bracing, shock wave or ultrasound therapy , but many of them lack sufficient evidence of beneficial effects. Photobiomodulation therapy (PBMT) alone or combined with static magnetic field (PBMT-sMF) has been shown to stimulate tendon healing, this suggests that therapy using laser or light-emitting diodes (LEDs) is efficacious for the symptoms associated with epicondylitis. According to the favorable results of PBMT-sMF in tendons repair processes, this type of therapy can be used as a therapeutic tool for management in epicondylitis, therefore, more investigations are necessary to establish the ideal parameters. Therefore, the aim of this project is to investigate the effects of PBMT-sMF, in the appropriate parameters, on degree of pain and quality of life of patients with lateral epicondylitis.
详细描述
To achieve the proposed objective it will be performed a multi-center, randomized, triple-blinded, placebo-controlled trial, with voluntary patients with lateral epicondylitis. Fifty patients will be randomly allocated to two treatment groups: 1. Active PBMT-sMF (MR5® Prototype Device) or Placebo PBMT-sMF (MR5® Prototype Device). The patients will be treated by a blinded therapist.
The patients randomly allocated to the different groups will be subjected to treatment two times a week for three consecutive weeks, each procedure administration three to four days apart.
The study will contain five phases: 1) pre-procedure activities; 2) pre-procedure assessment phase; 3) procedure administration phase; 4) procedure administration phase measures; 5) post-procedure administration phase.
The outcomes measured will be: degree of pain, forearm pain and disability, grip strength, TNF-α levels, subject satisfaction with overall outcome rating, perceived group assignment and adverse events.
The outcomes will be obtained at the stabilization phase (pre-procedure activities), baseline (pre-procedure assessment phase), 24 hours after the end of the treatment (procedure administration phase measures), and 30 days after the end of the treatment (post-procedure administration phase).
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)
盲法说明
A researcher will program the device (active PBMT-sMF or placebo PBMT-sMF) and will be instructed not to inform the patients or other researchers as to the type of treatment (active PBMT-sMF or placebo PBMT-sMF). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of the treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active PBMT-sMF or placebo PBMT-sMF).
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of pain around the lateral epicondyle for at least 1 month;
- •Self-reported Degree of Pain rating on the 0-100 VAS pain scale for the lateral epicondyle region is 50 or greater;
- •Tenderness localized to the epicondyle and anterodistal region of the epicondyle with palpation;
- •2 of 4 positive results of provocative tests comprising of Maudsley's, Cozen's, Thomsen and Mill's tests;
- •Aged between 18 and 50 years;
- •Both genders;
- •Patients fluent in Portuguese.
排除标准
- •hemophilia or any type of blood clotting disorder;
- •chronic immune impairment neoplasia;
- •cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord;
- •diabetes Type 1;
- •significant heart conditions including CHF and implantable heart devices such as a pacemaker;
- •current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
- •neurologic deficits;
- •cervical radiculopathy;
- •peripheral nerve disease;
- •rheumatoid arthritis;
- •shoulder disease;
- •radial tunnel syndrome;
- •previous surgery of the affected upper extremities;
- •congenital or acquired bony deformity in the ipsilateral upper extremity;
- •bilateral epicondylosis;
- •secondary orthopedic problems;
- •the initiation of opioid analgesia or corticosteroid or analgesic injection interventions within the previous 6 months;
- •local corticosteroids and/or botulinum toxin (Botox®) injection for Lateral Epicondyle pain relief within the prior 30 days;
- •medical tx; such as chiropractic care and acupuncture within last 30 days;
- •physical therapy intervention on the upper extremity in the previous year;
- •active infection, wound, or other external trauma to the areas to be treated with the laser;
- •medical, physical, or other contraindications for, or sensitivity to, light therapy;
- •serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;
- •pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
结局指标
主要结局
Degree of Pain Rating (VAS)
时间窗: 3 weeks (end of treatment)
Degree of pain rating will be measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'
次要结局
- Presence of Adverse Events(3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.)
- Forearm Pain and Disability(3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.)
- Grip Strength(3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.)
- TNF-α (Tumor Necrosis Factor-alpha) Levels(3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.)
- Subject Satisfaction With Overall Outcome Rating(3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.)
- Degree of Pain Rating (VAS)(4 weeks after the conclusion of the treatment.)
研究者
Ernesto Cesar Pinto Leal Junior
Principal investigator
University of Nove de Julho