Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Change in Pain from baseline at 12 weeks
研究概览
简要总结
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.
详细描述
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day.
The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 20 and 65 years of age.
- •The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
- •The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
- •The pain must be episodic.
- •BMI 18.5 - 29.9 kg/m
- •Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.
排除标准
- •Severe or terminal illnesses.
- •Subjects with pain associated with trauma.
- •Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
- •Subjects with known allergy to any of the components of the investigational product. the investigational product.
- •Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
- •Pregnant or lactating women.
- •Inability to understand the informed consent.
结局指标
主要结局
Change in Pain from baseline at 12 weeks
时间窗: The evolution of pain after consumption during 12 weeks will be measured.
Visual analog scale from 0 to 10. The higher the value, the more pain.
次要结局
- Evaluation of back pain: Promis-29 test(Day 1, at 4, 8 and 12 weeks later)
- Anxiety questionnaire(Day 1, at 4, 8 and 12 weeks later)
- Perceived stress(Day 1, at 4, 8 and 12 weeks later)
- Sleep quality(It will be measured twice, once at baseline or at the end of the study after 12 weeks of use)
- Physical activity(The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.)
- Wellbeing / wellness(Day 1, at 4, 8 and 12 weeks later)
- Sleep efficiency(The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.)
- Evaluation of back pain: Cornell(Day 1, at 4, 8 and 12 weeks later)
- Level of functionality: Roland Morris test(Day 1, at 4, 8 and 12 weeks later)
- Quality of life questionnaire(Day 1, at 4, 8 and 12 weeks later)
- Body composition(The test will be measured at baseline and after 12 weeks of consumption.)
- C Reactive Protein (PCR)(It will be measured twice, once at baseline or at the end of the study after 12 weeks.)
- Change in concomitant analgesic medication(The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis)
- Depression(Day 1, at 4, 8 and 12 weeks later)
- Interleukin 6 (IL-6)(It will be measured twice, once at baseline or at the end of the study after 12 weeks.)
- Liver safety variables(It will be measured twice, once at baseline or at the end of the study after 12 weeks.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia