Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain (Backin)

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Supplementation
• Intervention / Treatment: Dietary supplement: Experimental product; Other: Control product consumption

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: botanical extracts
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: UCAMCFE-00028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No