Health Condition 1: R298- Other symptoms and signs involvingthe nervous and musculoskeletal systems
Conditions
Interventions
Intervention1: Litemeds Pain Management Device: Litemedâ??s Pain Management device is a non-invasive, compact, portable, and wearable device which provides effective pain relief and functions based up
Sponsors
Litemed India Private Limited
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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.To evaluate safety and efficacy of the device on musculoskeletal (Acute and chronic) pain conditions. ii. To compare the average pain score between the subjects used test and control devices. 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 |
|---|---|
| i.To check the relapse time of the pain. ii.To check the efficacy of the device in different skin type. Timepoint: i. Efficacy of the device in different skin types is evaluated by using the Fitzpatrick scale and VAS scale. It is obtained in day 1 ii. Relapse time of the pain is noted through a phone call to the subject. It is done 24 hours after completion of treatment. | — |
Countries
India
Contacts
Public ContactDr Vinod Kumar
Litemed India Private limited
Outcome results
None listed