Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Fatigue and Biofreeze® on the Biomechanics of Running

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516240
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Holmes, Brock University

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.


Condition or disease Intervention/treatment Phase
Fatigue Other: Biofreeze Other: Placebo Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Fatigue and Biofreeze® on the Biomechanics of Running
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Biofreeze

Arm Intervention/treatment
Experimental: Experimental
Participants receive the topical analgesic, Biofreeze.
Other: Biofreeze
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 Comparator: Placebo
Participants receive a placebo cream.
Other: Placebo
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.




Primary Outcome Measures :
  1. Joint angles (degrees) [ Time Frame: 6 months ]
    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.

  2. Joint velocity (degrees/second) [ Time Frame: 6 months ]
    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.

  3. Joint acceleration (degrees/second^2) [ Time Frame: 6 months ]
    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.

  4. Temporal measures (stride length) [ Time Frame: 6 months ]
    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.

  5. Temporal measures (variability) [ Time Frame: 6 months ]
    Variability in stride measures throughout the repetition of the movement will be measured as a standard deviation.


Secondary Outcome Measures :
  1. Muscle activity (average) [ Time Frame: 6 months ]
    Average muscle activity (Surface Electromyography) will be evaluated for all muscles during all sessions. Activity will be evaluated during specific phases of a running motion. Raw signals will be full-wave rectified; digitally low-pass filtered (3Hz cut-off, 2nd order, and single pass Butterworth filtered) and normalized to the previously collected maximal voluntary contractions.

  2. Muscle activity (maximum) [ Time Frame: 6 months ]
    Maximum muscle activity (Surface Electromyography) will be evaluated for all muscles during all sessions. Activity will be evaluated during specific phases of a running motion. Raw signals will be full-wave rectified; digitally low-pass filtered (3Hz cut-off, 2nd order, and single pass Butterworth filtered) and normalized to the previously collected maximal voluntary contractions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age limits
  • Average 20 kilometers running per week

Exclusion Criteria:

  • No recent or current injuries that would affect ability to run

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516240


Locations
Layout table for location information
Canada, Ontario
Applied Health Sciences
St. Catharines, Ontario, Canada, L2S 3A1
Sponsors and Collaborators
Brock University
Investigators
Layout table for investigator information
Principal Investigator: Mike Holmes, PhD Brock University
Publications:
Layout table for additonal information
Responsible Party: Michael Holmes, Assistant Professor, Brock University
ClinicalTrials.gov Identifier: NCT03516240    
Other Study ID Numbers: BrockURun
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue