Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts

Conditions
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Supplementation, Back Pain

Intervention / Treatment
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* Dietary Supplement: Experimental product
* Other: Control product consumption


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botanical extracts high dose<br>Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. | Dietary Supplement: Experimental product<br>* Botanical extract<br>|
| Experimental: Botanical extracts low dose<br>Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. | Dietary Supplement: Experimental product<br>* Botanical extract<br>|
| Placebo Comparator: Control group<br>Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. | Other: Control product consumption<br>* Product with identical characteristics to the experimental product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain from baseline at 12 weeks | Visual analog scale from 0 to 10. The higher the value, the more pain. | The evolution of pain after consumption during 12 weeks will be measured. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concomitant analgesic medication | The change in the need for the use of analgesic medications will be evaluated | The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis | 
| Evaluation of back pain: Promis-29 test | Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain. | Day 1, at 4, 8 and 12 weeks later | 
| Evaluation of back pain: Cornell | The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) assesses musculoskeletal symptomatology in workers who perform sedentary and standing work. sedentary work and standing work. | Day 1, at 4, 8 and 12 weeks later | 
| Level of functionality: Roland Morris test | The Roland-Morris questionnaire is used to reliably determine the degree of physical degree of physical disability derived from non-specific low back pain. | Day 1, at 4, 8 and 12 weeks later | 
| Quality of life questionnaire | SF-36 test health questionnaire | Day 1, at 4, 8 and 12 weeks later | 
| Wellbeing / wellness | WHOQOL BREF test | Day 1, at 4, 8 and 12 weeks later | 
| Depression | Beck depression. Test to measure the level of depression of the subjects | Day 1, at 4, 8 and 12 weeks later | 
| Anxiety questionnaire | Test STAI, to measure the level of anxiety of the subjects | Day 1, at 4, 8 and 12 weeks later | 
| Perceived stress | Remor, 2001. Test to measure the level of stress of the subjects | Day 1, at 4, 8 and 12 weeks later | 
| Sleep quality | Measured by Pittsburgh test | It will be measured twice, once at baseline or at the end of the study after 12 weeks of use | 
| Body composition | It is a control variable. Measured by bioimpedance | The test will be measured at baseline and after 12 weeks of consumption. | 
| Physical activity | It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT | The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day. | 
| Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day. | 
| C Reactive Protein (PCR) | It is a blood test that measures inflammation levels. | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | 
| Interleukin 6 (IL-6) | It is a blood test that measures inflammation levels. | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | 
| Liver safety variables | 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) | It will be measured twice, once at baseline or at the end of the study after 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botanical extracts