Health Condition 1: M99-M99- Biomechanical lesions, not elsewhere classified
Conditions
Interventions
Intervention1: Myofatigue Forte Tablets: It is a combination of Palmitoylethanolamide and Acetyl-L-Carnitine which are Nutraceuticals that have demonstrated analgesic and anti-inflammatory properties
Sponsors
Fourrts (India) Laboratories Pvt.Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18-65 years. Clinical diagnosis of chronic lower back pain lasting more than three months. Minimum pain intensity of 4 on the Visual Analog Scale (VAS) at baseline. Ability to provide informed consent and comply with study protocols Degenerative discs disease without prolapses
Exclusion criteria
Exclusion criteria: Acute pain conditions or recent injury within the last three months. History of spinal surgery within the past six months. Pregnant or breastfeeding women. Severe comorbidities that could interfere with study outcomes. Participation in other clinical trials for lower back pain. Participants with Disc Prolapse, Lysis, Listhesis, Trauma, Tumors, Inflammatory pathologies are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 Inperson assessment Week 10 Telephonic check in Week 12 Final in person assessment This endpoint will help to determine the primary effectiveness of PEA versus physical therapy in alleviating pain.Timepoint: Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 Inperson assessment Week 10 Telephonic check in Week 12 Final in person assessment This endpoint will help to determine the primary effectiveness of PEA versus physical therapy in alleviating pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional improvement, accessed by the Oswestry disability index (ODI) which evaluates the degree of disability related to lower back pain. Quality of life evaluated, using short form health survey (SF-36), RMDQ which matches health-related quality of life across multiple domains. Timepoint: Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 In person assessment Week 10 Telephonic check in Week 12 Final in person assessment | — |
Countries
India
Contacts
Public ContactDr G Sudhir
Sri Ramachandra Institute of Higher Education and Research
Outcome results
None listed