Myalgia Clinical Trial
— UELOfficial title:
Evaluation of the Prophylactic Effects of the Flavonoid Diosmin on Delayed-onset Muscle Soreness in Humans: a Randomized, Double-blinded and Placebo-controlled Single-center Clinical Trial
The potential benefits of exercise for the treatment of chronic inflammatory diseases and pain have been well documented in the scientific literature. Psychiatric, neurological, metabolic and cardiovascular diseases are examples of conditions that impact the health and quality of life of the population. Due to the effects provided by exercise, it can modify the natural course of these diseases. This concept is important to justify the efforts made by government bodies committed to promoting exercise, such as the WHO. However, the habitual practice of physical activity following the primary guidelines may be hampered by some factors, including those that support the physiological repercussions of exercise on the body, such as muscle pain. In this sense, an important complicating factor such as delayed-onset muscle soreness (DOMS), present in the post-exercise recovery period, can impair adherence and permanence in physical activity programs, thus representing a considerable barrier to exercise promotion. They can also severely impair the performance of high-level athletes. Flavonoids, present in plants, but also in foods of the human diet, are known to have several biological properties, including analgesic, anti-inflammatory, and antioxidant effects. Currently, there are still few studies that have evaluated the effects of flavonoids on the development and evolution of DOMS in humans.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 35 Years |
Eligibility | Inclusion Criteria: - Be within the pre-determined age range. - Be able to perform the proposed intense dynamic exercise protocol. Exclusion Criteria: - Locomotor system dysfunctions. - Use of analgesic/anti-inflammatory medication at the time of recruitment. - Calorie-restricted diet or ergogenic supplementation. |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Estadual de Londrina | Londrina | Paraná |
Lead Sponsor | Collaborator |
---|---|
Sergio Marques Borghi | Universidade Norte do Paraná |
Brazil,
Borghi SM, Zaninelli TH, Saraiva-Santos T, Bertozzi MM, Cardoso RDR, Carvalho TT, Ferraz CR, Camilios-Neto D, Cunha FQ, Cunha TM, Pinho-Ribeiro FA, Casagrande R, Verri WA Jr. Brief research report: Repurposing pentoxifylline to treat intense acute swimming-Induced delayed-onset muscle soreness in mice: Targeting peripheral and spinal cord nociceptive mechanisms. Front Pharmacol. 2023 Jan 10;13:950314. doi: 10.3389/fphar.2022.950314. eCollection 2022. — View Citation
Bussulo SKD, Ferraz CR, Carvalho TT, Verri WA Jr, Borghi SM. Redox interactions of immune cells and muscle in the regulation of exercise-induced pain and analgesia: implications on the modulation of muscle nociceptor sensory neurons. Free Radic Res. 2021 Jul;55(7):757-775. doi: 10.1080/10715762.2021.1953696. Epub 2021 Jul 19. — View Citation
Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005. — View Citation
Heiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, Huttel M, Hotfiel T. Advances in Delayed-Onset Muscle Soreness (DOMS) - Part II: Treatment and Prevention. Sportverletz Sportschaden. 2019 Mar;33(1):21-29. doi: 10.1055/a-0810-3516. Epub 2019 Mar 13. — View Citation
Luque MZ, Aguiar AF, da Silva-Araujo AK, Zaninelli TH, Heintz OK, Saraiva-Santos T, Bertozzi MM, Souza NA, Junior EO, Verri WA Jr, Borghi SM. Evaluation of a preemptive intervention regimen with hesperidin methyl chalcone in delayed-onset muscle soreness in young adults: a randomized, double-blinded, and placebo-controlled trial study. Eur J Appl Physiol. 2023 Sep;123(9):1949-1964. doi: 10.1007/s00421-023-05207-2. Epub 2023 Apr 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle soreness | Evaluated by both digital algometer (in kilograms force; Kgf) and visual analogue (VAS) scale (in centimeters; cm), where 0 represents no pain and 10 the worst possible pain. | Basal, 24, and 48 hours after DOMS induction protocol | |
Secondary | Muscle tissue damage through the evaluation of the creatine phosphokinase (CPK) levels. | Evaluated by spectrophotometric analysis using commercial kits (in milligram per liter; mg/L) | Basal, 24, and 48 hours after DOMS induction protocol | |
Secondary | Plasmatic lipid peroxidation levels | Evaluated by spectrophotometric analysis (in micromol per liter; µmol/L). | Basal, 24, and 48 hours after DOMS induction protocol | |
Secondary | Plasmatic total antioxidant status | Evaluated by spectrophotometric analysis (in millimol per liter; mmol/L). | Basal, 24, and 48 hours after DOMS induction protocol | |
Secondary | Recovery of muscle function through the evaluation of the average and maximum torque of the knee extension for determining quadriceps strength (maximum voluntary isometric contraction; MVIC). | Evaluated by isometric dynamometer (flexor/extension chair, in newton per meter; N/m). | Basal, 24, and 48 hours after DOMS induction protocol | |
Secondary | Recovery of muscle function through vertical jump height. | Evaluated by jump strength (in milliseconds; msec). | Basal, 24, and 48 hours after DOMS induction protocol. | |
Secondary | Bipedal and single-legged (unipedal) postural balance. | Evaluated through the antero-posterior (AP) and mediolateral (ML) displacement velocities (in centimeter per seconds; cm/sec). | Basal, 24, and 48 hours after DOMS induction protocol. |
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