The Effect of Fatigue and Biofreeze® on the Biomechanics of Running
1 other identifier
interventional
20
1 country
1
Brief Summary
Delayed onset muscle soreness (DOMS) can be identified as the muscular pain that occurs due to intense use of skeletal muscle through exercise or other activities performed intense enough or long enough to cause minor damage(Cheung et al., 2003). DOMS usually begins to show symptoms 24 hours post-activity, becomes most intense 48-72 hours post-activity and can sometimes last up to 5-10 days in ordinary cases(Cheung et al., 2003; Dutto and Braun 2004). Typical less severe cases still can cause an individual to alter proper movement mechanics - this alteration in mechanics can lead to the further injuring of the involved or compensating skeletal muscle tissues and the associated joints and skeletal structures. DOMS-related muscular pain can lead to functional deficits and altered movement mechanics that can lead to a greater risk of further injury or sources of pain. The body does this by trying to avoid the initial source of pain by adopting some form of compensation (such as a limp when walking) which may help reduce pain at the initial source but lead to another source of pain or risk injury at another joint or limb. DOMS is a common complaint of many runners from novice to expert and due to the increased forces in running, a compensatory pattern in walking is exaggerated in running and can affect the compensating structures to an even greater extent, further increasing the risk of injury. Biofreeze®, a topical analgesic, is used to block the pain signal from the affected structures to the brain when applied to muscles experiencing delayed onset muscle soreness. Blocking the pain signal from DOMS should allow an individual to restore their natural movement mechanics. The purpose of this study is to assess the interaction between Biofreeze® and delayed onset muscle soreness and how it affects movement mechanics and muscle function. Hypothesis: The application of a topical analgesic (Biofreeze®) on muscles experiencing delayed onset muscle soreness (DOMS) will increase force production and return running biomechanics to pre-DOMS values.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 27, 2020
May 1, 2020
1.2 years
April 24, 2018
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Joint angles (degrees)
Digitized landmarks from the trunk as well as the lower extremities will be used to create anatomical frames of reference for each modeled segment. Three-dimensional coordinates for the digitized landmarks will be continuously monitored using the fixed spatial relationship with the rigid body affixed to the segment. All kinematic data will be filtered at a rate of 6 Hz using a digital Butterworth filter. Anatomical frames of reference derived from the digitized landmarks will be used to determine joint angles in degrees throughout the selected tasks. Joint angle data will be measured for the hip, knee and ankle.
6 months
Joint velocity (degrees/second)
Digitized landmarks from the trunk as well as the lower extremities will be used to create anatomical frames of reference for each modeled segment. Three-dimensional coordinates for the digitized landmarks will be continuously monitored using the fixed spatial relationship with the rigid body affixed to the segment. All kinematic data will be filtered at a rate of 6 Hz using a digital Butterworth filter. Anatomical frames of reference derived from the digitized landmarks will be used to determine joint angles and velocity in degrees/second will be derived. Joint velocity data will be measured for the hip, knee and ankle.
6 months
Joint acceleration (degrees/second^2)
Digitized landmarks from the trunk as well as the lower extremities will be used to create anatomical frames of reference for each modeled segment. Three-dimensional coordinates for the digitized landmarks will be continuously monitored using the fixed spatial relationship with the rigid body affixed to the segment. All kinematic data will be filtered at a rate of 6 Hz using a digital Butterworth filter. Joint acceleration will be derived from joint velocity throughout the selected tasks. Joint acceleration data will be measured for the hip, knee and ankle.
6 months
Temporal measures (stride length)
Motion capture data will be used to determine the phase of running stride (ie. Heel strike, toe off, swing, etc.). This data will be used to determined stride length.
6 months
Temporal measures (variability)
Variability in stride measures throughout the repetition of the movement will be measured as a standard deviation.
6 months
Secondary Outcomes (2)
Muscle activity (average)
6 months
Muscle activity (maximum)
6 months
Study Arms (2)
Experimental
EXPERIMENTALParticipants receive the topical analgesic, Biofreeze.
Placebo
PLACEBO COMPARATORParticipants receive a placebo cream.
Interventions
Following a procedure that induces muscle fatigue in the lower extremity, a topical cream will be applied over the quadriceps. The cream will be either a topical analgesic (Biofreeze) or a placebo cream. Evaluation of the movement kinematics and kinetics will be evaluated for each group.
Following a procedure that induces muscle fatigue in the lower extremity, a topical cream will be applied over the quadriceps. The cream will be either a topical analgesic (Biofreeze) or a placebo cream. Evaluation of the movement kinematics and kinetics will be evaluated for each group. Placebo cream will be blinded to both the experimenter and study participant. It will look and smell the same and will be in the same packaging.
Eligibility Criteria
You may qualify if:
- Age limits
- Average 20 kilometers running per week
You may not qualify if:
- No recent or current injuries that would affect ability to run
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brock Universitylead
Study Sites (1)
Applied Health Sciences
St. Catharines, Ontario, L2S 3A1, Canada
Related Publications (7)
Dutto DJ, Braun WA. DOMS-associated changes in ankle and knee joint dynamics during running. Med Sci Sports Exerc. 2004 Apr;36(4):560-6. doi: 10.1249/01.mss.0000121957.83226.cc.
PMID: 15064581BACKGROUNDPaquette MR, Peel SA, Schilling BK, Melcher DA, Bloomer RJ. Soreness-related changes in three-dimensional running biomechanics following eccentric knee extensor exercise. Eur J Sport Sci. 2017 Jun;17(5):546-554. doi: 10.1080/17461391.2017.1290140. Epub 2017 Feb 22.
PMID: 28276912BACKGROUNDPaschalis V, Giakas G, Baltzopoulos V, Jamurtas AZ, Theoharis V, Kotzamanidis C, Koutedakis Y. The effects of muscle damage following eccentric exercise on gait biomechanics. Gait Posture. 2007 Feb;25(2):236-42. doi: 10.1016/j.gaitpost.2006.04.002. Epub 2006 May 22.
PMID: 16714113BACKGROUNDTsatalas T, Giakas G, Spyropoulos G, Paschalis V, Nikolaidis MG, Tsaopoulos DE, Theodorou AA, Jamurtas AZ, Koutedakis Y. The effects of muscle damage on walking biomechanics are speed-dependent. Eur J Appl Physiol. 2010 Nov;110(5):977-88. doi: 10.1007/s00421-010-1589-1. Epub 2010 Jul 29.
PMID: 20668871BACKGROUNDEllis C, Himbert A, Thompson AW, Mincer A, & Lake DA. The Effect Of Biofreeze On Delayed Onset Muscle Soreness. Journal of Orthopaedic & Sports Physical, 35(1): A34, 2005.
BACKGROUNDJohar P, Grover V, Topp R, Behm DG. A comparison of topical menthol to ice on pain, evoked tetanic and voluntary force during delayed onset muscle soreness. Int J Sports Phys Ther. 2012 Jun;7(3):314-22.
PMID: 22666646BACKGROUNDCheung 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.
PMID: 12617692BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mike Holmes, PhD
Brock University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 24, 2018
First Posted
May 4, 2018
Study Start
June 1, 2018
Primary Completion
August 30, 2019
Study Completion
September 1, 2019
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share