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NCT05597189
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
Conditions: Supplementation, Back Pain
Sex: All
Ages: 20 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 135
Sponsor: Universidad Católica San Antonio de Murcia
Location: Spain
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05597189). StuddyBuddy aggregates publicly available trial information.