Evaluation of comparative efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per the computer-generated table. The clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, MGACHRC, Salod (H), and Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a randomized, open-labeled, standard-controlled equivalence clinical trial. It will include a 30-day treatment period and a follow-up period on the 20th and 30th days and an assessment period on the 0th, 10th, 20th, and 30th days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written informed consent and of either gender between the ages of 20 and 60 years.
- •Patients with non-traumatic Muscular LBP having acute (up to 12 weeks) or Chronic (up to 3 months) low back pain Patient able to attend sessions and follow up regularly.
- •Patient indicated for massage/abhyang with simple oil and aromatic oil.
排除标准
- •Patients with LBP but suffering from Trauma, Fractures , hemi/paraparesis, infections Inflammatory diseases, menstruation, and PID.
- •History of spinal surgery Pregnant and lactating women with Neurological deficits.
结局指标
主要结局
To assess and compare the efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial
时间窗: at baseline, 20 days and 30 days
次要结局
- Comparison and Assessment of the Efficacy of two Massage techniques (Ayurvedic versus Swedish) by using Aromatic versus Non-Aromatic Oils in the management of Non-Traumatic Low Back Pain: A Randomized Four-Arm Parallel Clinical Trial(at baseline, 2 weeks 6 days and 4 weeks 2 days)
研究者
Dr Samruddhi Anil Walke
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra India 442001