Methylsulfonylmethane on Knee Laxity
Completed · Not applicable · Has a placebo group
Conditions studied: Ligament Injury, Ligament; Laxity, Tendon Rupture, Tendon Injuries
In brief
The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females. As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed work is designed to determine whether MSM can decrease the negative effect of estrogen on knee laxity in females. Ligament function is determined by the content and cross-linking of collagen, which is influenced by a milieu of biochemical and mechanical parameters. The greater the amount and cross-linking the greater the stiffness and strength of these connective tissues. In engineered ligaments it has been previously shown that the high levels of estrogen, normally present in the days before and after ovulation, can inhibit the cross-linking enzyme lysyl oxidase. This decrease in collagen cross-linking likely increases connective tissue laxity and contributes to observed 4-fold greater occurrence of anterior cruciate ligament (ACL) rupture in females. Conversely, MSM increases collagen cross-linking and recent work conducted by the Baar lab in engineered human ligaments treated with high estrogen demonstrated that MSM could completely reverse the effects of estrogen on ligament mechanics. The proposed research aims to advance this promising pre-clinical data and apply in a clinical trial. This research also proposes to quantify that knee laxity increases up to 5mm between the first day of menstruation and the day after ovulation and also that the magnitude of the increase in laxity is directly related to the magnitude of the change in estrogen. Importantly, a direct relationship between knee laxity and ACL rupture exists. For every 1.3mm increase in anterior-posterior knee displacement, the odds of ACL rupture increase 4-fold. Therefore, any treatment that decreases knee laxity could be expected to reduce ACL ruptures and have widespread application across the general active population and high-level athletics.
Key facts
- Study ID
- NCT03747198
- Run by
- University of California, Davis
- People needed
- 32
- Starts
- 2019-02-01
- Expected to finish
- 2019-10-01
- Last updated by the study team
- 2020-06-01
Who can join
Age: 18 and older, up to 30. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- • Regular menstrual cycle (\~1 x month)
- Not using oral contraceptive
- No history of serious knee injury (e.g. ACL rupture)
- Not currently pregnant (known)
- Not routinely taking medication or supplements that would interact with study measures or be contraindicated (e.g. steroid injections)
You may not qualify if…
- • Irregular menstrual cycling (1 x month)
- Using oral contraceptive
- History of serious knee injury (e.g. ACL rupture)
- Currently pregnant or potential of being pregnant
- Routinely taking medication or supplements that would interact with study measures or be contraindicated (e.g. steroid injections)
Where it is running
- Neurobiology, Physiology & Behaviour — Davis, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.