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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Supplementation; Back Pain

Treatments: Dietary Supplement: Experimental product; Other: Control product consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT05597189

UCAMCFE-00028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Botanical extracts high dose

Experimental group

Description:

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

Treatment:

Dietary Supplement: Experimental product

Botanical extracts low dose

Experimental group

Description:

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

Treatment:

Dietary Supplement: Experimental product

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Control product consumption