Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Back Pain Clinical Trial

— Backin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597189
• Other study ID #: UCAMCFE-00028
• Status: Completed
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2022
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 31, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Supplementation

Intervention

Dietary Supplement:
• Experimental product
Botanical extract

Other:
• Control product consumption
Product with identical characteristics to the experimental product.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life questionnaire	SF-36 test health questionnaire	Day 1, at 4, 8 and 12 weeks later
Secondary	Wellbeing / wellness	WHOQOL BREF test	Day 1, at 4, 8 and 12 weeks later
Secondary	Depression	Beck depression. Test to measure the level of depression of the subjects	Day 1, at 4, 8 and 12 weeks later
Secondary	Anxiety questionnaire	Test STAI, to measure the level of anxiety of the subjects	Day 1, at 4, 8 and 12 weeks later
Secondary	Perceived stress	Remor, 2001. Test to measure the level of stress of the subjects	Day 1, at 4, 8 and 12 weeks later
Secondary	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
Secondary	Body composition	It is a control variable. Measured by bioimpedance	The test will be measured at baseline and after 12 weeks of consumption.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.