Clinical trial NCT05597189: Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
Official title: Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplementation
Back Pain
Keywords: botanical extracts
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain from baseline at 12 weeks
timeFrame: The evolution of pain after consumption during 12 weeks will be measured.
Secondary outcomes:
measure: Change in concomitant analgesic medication
timeFrame: The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis
measure: Evaluation of back pain: Promis-29 test
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Evaluation of back pain: Cornell
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Level of functionality: Roland Morris test
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Quality of life questionnaire
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Wellbeing / wellness
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Depression
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Anxiety questionnaire
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Perceived stress
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Sleep quality
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
measure: Body composition
timeFrame: The test will be measured at baseline and after 12 weeks of consumption.
measure: Physical activity
timeFrame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
measure: Sleep efficiency
timeFrame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
measure: C Reactive Protein (PCR)
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
measure: Interleukin 6 (IL-6)
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
measure: Liver safety variables
timeFrame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: