Comparative Efficacy of Myo Fatige Forte Tablet Palmitoylethanolamide Supplementation over physiotherapy in the management of chronic lower back pain A randomized control Bi centric trial
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit
研究概览
简要总结
Primary objectives· To evaluate the effectiveness of Myo Fatige Forte Tablet in reducing the pain intensity, compared to physical therapy in patient with chronic lower back pain.
Secondary objectives· To assess improvement in functional outcomes as measured by the Oswestry Disability index (ODI)
· To evaluate changes in their quality of life as assessed by short form health survey (SF-36)
· To monitor any adverse effects associated with each intervention through participant diaries.
· To assess the overall psychological state during the study period through participant diaries
· To Assess primary care patients with low back pain for prognostic indicators that are relevant to initial decision making (The Keele STarT Back Screening Tool)
· To assess improvement and clinical outcomes using the Roland Morris disability questionnaire for back pain.
Exploratory objective· To assess the effectives of combination therapy relative to isolated interventions
End points and safety assessmentPrimary Endpoints· Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from baseline to week six and week 12. This endpoint will help to determine the primary effectiveness of Myo Fatige Forte Tablet over physical therapy in alleviating pain.
Secondary endpoints· 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.
Exploratory endpoints· Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from baseline to week six and week 12. This endpoint will help to determine the Combined effectiveness of Myo Fatige Forte Tablet as a nutraceutical supplement in aiding the treatment of cLBP with minimal to no side effect.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit
时间窗: 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.
Week 2 In person assessment
时间窗: 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.
Week 4 In person assessment
时间窗: 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.
Week 6 Telephonic check in
时间窗: 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.
Week 8 Inperson assessment
时间窗: 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.
Week 10 Telephonic check in
时间窗: 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.
Week 12 Final in person assessment
时间窗: 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.
This endpoint will help to determine the primary effectiveness of PEA versus physical therapy in alleviating pain.
时间窗: 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.
次要结局
- 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.)
研究者
Dr G Sudhir
Sri Ramachandra Institute of Higher Education and Research