Evaluation of the Effect of Multi Radiance Medical® Super Pulsed Laser for Adjunctive Use in Providing Temporary Relief of Chronic Knee Pain of Musculoskeletal Origin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Degree of pain rating
研究概览
简要总结
Knee pain is among the most common reasons for musculoskeletal pain consultations, accounting for nearly 4 million primary care visits annually. Knee pain can have different causes such as, tendinopathies, synovitis, bursitis, trauma, etc.
Considering the importance and high incidence of musculoskeletal disorders that affect the knee joint, a variety of therapeutic modalities has been employed to alleviate pain and repair the tissue. Among these conservative treatments, photobiomodulation therapy (PBMT) has been shown to stimulate tendon and ligament healing, and decrease the pain.
Therefore, the aim of this study is to determine the effectiveness of the Multi Radiance Medical® Super Pulsed Laser, manufactured by Multi Radiance Medical®, for adjunctive use in providing temporary relief of chronic knee pain of musculoskeletal origin.
详细描述
To achieve the proposed objectives it will be performed a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic knee pain. Eighty-six patients will be randomly allocated to two treatment groups: 1. Active Multi Radiance Medical® Super Pulsed Laser or Placebo Multi Radiance Medical® Super Pulsed Laser. The patients will be treated by a blinded therapist.
Treatment administration will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments (each treatment administration one to two days apart).
The outcomes will be obtained at the stabilization phase, baseline (pre-procedure), end of treatment and one week after the conclusion of treatment.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles.
The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.332.202. Board Affiliation: Comissão Nacional de Ética em Pesquisa (CONEP) Phone: +55113385-9010 - Email: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil.
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 (placebo or active) and will be instructed not to inform the patients or other researchers as to the type of treatment (placebo or active). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of 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 (placebo or active).
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
- •Signed consent form.
- •Aged between 18 and 50 years, inclusive.
- •Any gender.
- •Subject is fluent in Portuguese.
- •The volunteers' presenting primary (dominant) pain is in the region of the right or left knee only. i.e., it is unilateral.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is 50 or greater.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is less than
- •Knee pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months.
- •Volunteers' knee pain is of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the principal investigator based on any one or combination of the following:
- •Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation.
- •Previous Records Review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of Degenerative Joint Disorder (DJD).
- •Medical history consistent with one of the etiologies of knee pain falling within the scope of this study.
- •Physical examination of the knee that yields one or both of the following findings: Increased pain upon range of motion and/or increased pain and weakness upon knee extension, knee flexion, or gait.
- •Subject is willing and able to maintain his or her individualized pain regimen as determined by the study principal investigator at baseline as needed to manage any knee pain that may arise throughout the course of study duration, whilst refraining from consuming other over the counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, and/or partaking in other treatments/therapies.
排除标准
- •A volunteer who satisfies any one or more of the following criteria will be excluded from study participation:
- •The volunteers' presenting primary pain is located outside or in addition to the knee.
- •The volunteers' presenting primary pain is bilateral, i.e., equally dominant in the right and left knees.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is less than
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is 20 or greater.
- •Knee pain is acute, defined as having persisted less than half the time over less than the last 3 months.
- •Knee pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months.
- •Volunteers' knee pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strains, and sprains from traumatic or non-traumatic origin, and/or the etiology of the subject's knee pain cannot be satisfactorily ruled out.
- •Prior surgical intervention to the target knee that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- •Neurologic deficits that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- •Peripheral nerve disease.
- •Rheumatoid arthritis.
- •Hip or ankle disease.
- •Congenital or acquired bony deformity in the ipsilateral lower extremity.
- •Secondary orthopedic problems that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- •Local corticosteroids and/or botulinum toxin (Botox®) injection for knee pain relief within 30 days prior to study enrollment.
- •Treatments such as chiropractic care, and acupuncture within 30 days prior to study enrollment.
- •Current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain,
- •Current cancer or treatment for cancer in the past 6 months.
- •Significant heart conditions including chronic heart failure (CHF) and implantable heart devices such as a pacemaker.
- •Active infection, wound, or other external trauma to the areas to be treated with the PBMT.
- •Medical, physical, or other contraindications for, or sensitivity to, light therapy.
- •Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- •Female subject of childbearing age who is unwilling to engage in effective medical contraceptive use while sexually active during the study procedure administration phase.
- •Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- •Developmental disability or cognitive impairment that in the opinion of the principal investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- •Any other medical condition or medication use that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
结局指标
主要结局
Degree of pain rating
时间窗: 4 weeks (end of treatment).
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
次要结局
- Patient satisfaction(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Adverse events(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Levels of Prostaglandin E2 (PGE2)(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Subjective knee evaluation(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Degree of pain rating(One-week after the conclusion of the treatment.)
- Blinding efficacy(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
研究者
Ernesto Cesar Pinto Leal Junior
Full professor
University of Nove de Julho