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Completed

NCT Number: NCT05597189

Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

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.

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Key information

Conditions

Supplementation Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental product

Dietary Supplement

Botanical extract

Control product consumption

Other

Product with identical characteristics to the experimental product.

Primary outcomes

  1. Change in Pain from baseline at 12 weeks

    Time frame: 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 outcomes

  1. Change in concomitant analgesic medication

    Time frame: 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

  2. Evaluation of back pain: Promis-29 test

    Time frame: 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.

  3. Evaluation of back pain: Cornell

    Time frame: 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.

  4. Level of functionality: Roland Morris test

    Time frame: 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.

  5. Quality of life questionnaire

    Time frame: Day 1, at 4, 8 and 12 weeks later

    SF-36 test health questionnaire

  6. Wellbeing / wellness

    Time frame: Day 1, at 4, 8 and 12 weeks later

    WHOQOL BREF test

  7. Depression

    Time frame: Day 1, at 4, 8 and 12 weeks later

    Beck depression. Test to measure the level of depression of the subjects

  8. Anxiety questionnaire

    Time frame: Day 1, at 4, 8 and 12 weeks later

    Test STAI, to measure the level of anxiety of the subjects

  9. Perceived stress

    Time frame: Day 1, at 4, 8 and 12 weeks later

    Remor, 2001. Test to measure the level of stress of the subjects

  10. Sleep quality

    Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use

    Measured by Pittsburgh test

  11. Body composition

    Time frame: The test will be measured at baseline and after 12 weeks of consumption.

    It is a control variable. Measured by bioimpedance

  12. Physical activity

    Time frame: 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

  13. Sleep efficiency

    Time frame: 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

  14. C Reactive Protein (PCR)

    Time frame: 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.

  15. Interleukin 6 (IL-6)

    Time frame: 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.

  16. Liver safety variables

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: Backin

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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