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

Primary Purpose

Supplementation, Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Experimental product

Control product consumption

About this trial

This is an interventional other trial for Supplementation focused on measuring botanical extracts

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Catholic University of MurciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Botanical extracts high dose

Botanical extracts low dose

Control group

Arm Description

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Outcomes

Primary Outcome Measures

Change in Pain from baseline at 12 weeks

Visual analog scale from 0 to 10. The higher the value, the more pain.

Secondary Outcome Measures

Change in concomitant analgesic medication

The change in the need for the use of analgesic medications will be evaluated

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.

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.

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.

Quality of life questionnaire

SF-36 test health questionnaire

Wellbeing / wellness

WHOQOL BREF test

Depression

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

Anxiety questionnaire

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

Perceived stress

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

Sleep quality

Measured by Pittsburgh test

Body composition

It is a control variable. Measured by bioimpedance

Physical activity

It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT

Sleep efficiency

Measured by accelerometry, with Actigraph wGT3X-BT

C Reactive Protein (PCR)

It is a blood test that measures inflammation levels.

Interleukin 6 (IL-6)

It is a blood test that measures inflammation levels.

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)

Full Information

NCT ID

NCT05597189

First Posted

October 24, 2022

Last Updated

November 1, 2022

Sponsor

Universidad Católica San Antonio de Murcia

1. Study Identification

Unique Protocol Identification Number

NCT05597189

Brief Title

Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Acronym

Backin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

June 26, 2023 (Anticipated)

Study Completion Date

July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Supplementation, Back Pain

Keywords

botanical extracts

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Botanical extracts high dose

Arm Type

Experimental

Arm Description

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Arm Title

Botanical extracts low dose

Arm Type

Experimental

Arm Description

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Intervention Type

Dietary Supplement

Intervention Name(s)

Experimental product

Intervention Description

Botanical extract

Intervention Type

Other

Intervention Name(s)

Control product consumption

Intervention Description

Product with identical characteristics to the experimental product.

Primary Outcome Measure Information:

Title

Change in Pain from baseline at 12 weeks

Description

Visual analog scale from 0 to 10. The higher the value, the more pain.

Time Frame

The evolution of pain after consumption during 12 weeks will be measured.

Secondary Outcome Measure Information:

Title

Change in concomitant analgesic medication

Description

The change in the need for the use of analgesic medications will be evaluated

Time Frame

The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis

Title

Evaluation of back pain: Promis-29 test

Description

Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain.

Time Frame