Health Condition 1: R298- Other symptoms and signs involvingthe nervous and musculoskeletal systems
Conditions
Interventions
Intervention1: Non-invasive pain reliever: Non-invasive pain reliever is a portable and miniaturised model which relieves Musculoskeletal pain (Acute and Chronic pain) immediately after the treatment
Sponsors
Dr Surya Prakash Maguluri
Biofi Medical Healthcare India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of the device on musculoskeletal (Acute and chronic) pain conditions.Timepoint: i. Safety evaluation is done by noting AE and SAEs. It is obtained in day 1. ii. Efficacy is evaluated using Visual Analog Scale (VAS scale). It is obtained in day 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| To check efficacy of the device on different skin Colour. To check the relapse time of the pain.Timepoint: Efficacy of the device in different skin Colour is evaluated using Fitzpatriks scale and VAS scale. It is obtained in Visit 1. Relapse time of the pain is collected by calling the subject at 8th to 12th hour and at 24th hour from the treatment time. | — |
Countries
India
Contacts
Public ContactDr Rohith
Biofi Medical Healthcare India Pvt Ltd
Outcome results
None listed