CTRI/2021/12/039056暂停未知
A study to Evaluate the Safety and Efficacy of NIPRA - Double blind, Randomized, Controlled, Multicentric Study.
Dr Surya Prakash Maguluri0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
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 <3 or 6 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 to 6 months and is not only dependent on the time factor but on healing time also. e.g.: 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 of 3 to 7 in VAS PAIN 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. Patient who participated in other study for less than 3 months.
- •ii. Pain condition to be medically managed by the doctor or any physician.
- •iii. 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.
- •iv. Subjects having implants impregnated into the body.
- •v. Subject undergoing chemotherapy.
- •vi. Subject who is suffering with visceral pain.
- •vii. Active infection, wound or other external trauma to the areas to be treated with the LED.
- •viii. Medical, physical, or other contraindications for, or sensitivity to light therapy.
- •ix. Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- •x. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- •xi. 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.
- •xii. Use of any one or more of the following analgesics, or an equivalent, within 24 hours prior to initiation of the study procedure administration with Biofiââ?¬•s non-invasive pain reliever.
- •xiii. OTC NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin) and naproxen (Aleve), Prescription NSAIDs such as ibuprofen, diclofenac.
- •xiv. Subjects with fracture and broken bone pain are excluded.
- •xv. Subject with cervical spondylosis is excluded.
研究者
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