CTRI/2022/07/043775已完成未知
A study to evaluate the safety and efficacy of Litemedâ??s pain management device â?? Double blind, Randomized, controlled, multi-centric study.
itemed India Private Limited0 个研究点目标入组 240 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •i.Adults, 18 to 60 years of age at the time of screening either gender.
- •ii.Subjects with musculoskeletal pain, Acute pain can be defined as having been present for a short period (typically less than 3 months that is to say associated with a healing injury or pathology. eg: ligament sprain, muscle/tendon strain, back pain. Chronic pain can be defined by its persistence beyond an expected time frame for healing and it lasts more than 3 and is not only dependent on the time factor but on healing time also. eg: lower back pain, tendonitis, untreated acute pain.
- •iii.Able to comprehend and willing to sign the informed consent form and follow the study protocol.
- •iv.Significant pain score of 4 to 7 in VAS scale up to 10.
- •v.Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of his or her pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
排除标准
- •i. Subject who participated in other study for less than 3 months.
- •ii. Pain condition to be medically managed by the doctor or any physician.
- •iii. Subjects with special disability (Deaf and Dumb)
- •iv. A condition, which in the opinion of the investigator or designee, would put the person or study at risk. E.g.: arthritic pain, Neuropathic pain conditions, Psychosomatic pain condition, Deep vein thrombosis, Varicose veins, Gout, Ganglionic cysts.
- •v.Subjects with allergic reaction to drugs specifically Aceclofenac and Diclofenac (rescue medication).
- •vi. Subjects having implants impregnated into selected pain site of the body.
- •vii. Subjects undergoing chemotherapy.
- •viii. Subjects who are suffering with Visceral pain.
- •ix. Active infection, wound or other external trauma to the areas to be treated with the LED.
- •x. Medical, physical, or other contraindications for, or sensitivity to light therapy.
- •xi. Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- •xii Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- •xiii. Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- •xiv. Use of any one or more analgesics, or an equivalent, within 24 hours prior to initiation of the study procedure administration with Litemedâ??s pain management device.
- •xv. Subjects with fracture and broken bone pain.
- •xvi. Subject with cervical spondylosis.
研究者
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