Supplementation, Back Pain
Conditions
Keywords
botanical extracts
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTExperimental product
Botanical extract
Product with identical characteristics to the experimental product.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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/m2. * Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain from baseline at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety questionnaire | Day 1, at 4, 8 and 12 weeks later | Test STAI, to measure the level of anxiety of the subjects |
| Perceived stress | Day 1, at 4, 8 and 12 weeks later | Remor, 2001. Test to measure the level of stress of the subjects |
| Sleep quality | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | Measured by Pittsburgh test |
| 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 | The change in the need for the use of analgesic medications will be evaluated |
| Evaluation of back pain: Promis-29 test | Day 1, at 4, 8 and 12 weeks later | Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain. |
| Evaluation of back pain: Cornell | Day 1, at 4, 8 and 12 weeks later | The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) assesses musculoskeletal symptomatology in workers who perform sedentary and standing work. sedentary work and standing work. |
| Level of functionality: Roland Morris test | Day 1, at 4, 8 and 12 weeks later | The Roland-Morris questionnaire is used to reliably determine the degree of physical degree of physical disability derived from non-specific low back pain. |
| Body composition | The test will be measured at baseline and after 12 weeks of consumption. | It is a control variable. Measured by bioimpedance |
| Wellbeing / wellness | Day 1, at 4, 8 and 12 weeks later | WHOQOL BREF test |
| Depression | Day 1, at 4, 8 and 12 weeks later | Beck depression. Test to measure the level of depression of the subjects |
| 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. | It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT |
| 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. | Measured by accelerometry, with Actigraph wGT3X-BT |
| C Reactive Protein (PCR) | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | It is a blood test that measures inflammation levels. |
| Interleukin 6 (IL-6) | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | It is a blood test that measures inflammation levels. |
| Liver safety variables | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L) |
| Quality of life questionnaire | Day 1, at 4, 8 and 12 weeks later | SF-36 test health questionnaire |
Countries
Spain
Outcome results
None listed