NCT03516240

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

April 24, 2018

Last Update Submit

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

EXPERIMENTAL

Participants receive the topical analgesic, Biofreeze.

Other: Biofreeze

Placebo

PLACEBO COMPARATOR

Participants receive a placebo cream.

Other: Placebo

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.

Experimental
PlaceboOTHER

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.

Placebo

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Applied Health Sciences

St. Catharines, Ontario, L2S 3A1, Canada

Location

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: 15064581BACKGROUND
  • Paquette 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: 28276912BACKGROUND
  • Paschalis 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: 16714113BACKGROUND
  • Tsatalas 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: 20668871BACKGROUND
  • Ellis 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.

    BACKGROUND
  • Johar 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: 22666646BACKGROUND
  • 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.

    PMID: 12617692BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mike Holmes, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

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

Locations