Health Condition 1: - Health Condition 2: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between 18-65yrs of age of either gender with painful muscle spasms attending Orthopaedic OPD. 2. Willingness to give written informed consent and available for regular follow up and examination.
Exclusion criteria
Exclusion criteria: 1. Patients with history of liver and kidney damage, cardiovascular disease, acid peptic diseases 2. Pregnant and lactating mothers 3. Patients allergic to NSAIDS and skeletal muscle relaxants or prior history of asthma or hypersensitivity potentially requiring concomitant treatment 4. Patients treated with NSAIDS or skeletal muscle relaxants 1 week prior to study 5. Patients with severe concurrent systemic diseases including bleeding diathesis, on anticoagulant therapy. 6. Patients with malignancy, osteoporosis or previous history of lumbar spine surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ The primary efficacy end point of the drug therapy for the intended purpose of treatment will be evaluated through pain assessment scale using VASTimepoint: VAS will be assessed at baseline, 3rd day and 7th day visit to the OPD | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary efficacy end point by patients global assessment in response to treatment (PGART)Timepoint: â?¢ Patients Global assessment in response to treatment-PGART, is measured at the end of the study on a scale of 0 to 4. 0-Poor, 1-Fair, 2-Good, 3-Very Good, 4- Excellent. | — |
Countries
India
Contacts
KIMS, Bangalore