FatigueNCT03516240
The Effect of Fatigue and Biofreeze® on the Biomechanics of Running
A study testing Biofreeze in people with Fatigue, run by Brock University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 17 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Biofreeze
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age limits
- Average 20 kilometers running per week
Who cannot join
- No recent or current injuries that would affect ability to run
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Delayed onset muscle soreness (DOMS) is a common complaint of many runners, from novice to expert. DOMS can affect the primary movers in locomotion, including but not limited to the hip flexors and extensors, knee flexors and extensors, and the ankle plantar flexors. When running with DOMS, hip, knee, and ankle mechanics can be affected in such that they may cause protective compensation in order to prevent further damage or attenuate pain in the affected musculature. One common occurrence is DOMS in the knee extensors following prolonged running. DOMS occurring in the knee extensors can greatly affect sagittal knee joint biomechanics (Dutto and Braun 2004; Paquette et al., 2017). More specifically, these changes in knee mechanics can increase knee stiffness at initial stance, resulting in an increase in vertical leg stiffness. This change in knee stiffness potentially serves as a protective compensation mechanism against lengthening of the knee extensors (Paschalis et al., 2007; Tsatalas et al., 2010). Changing running mechanics (as a result of DOMS, or fatigue) can potentially lead to an increased risk of running related injury.
One potential way to reduce or alleviate the influence of muscle soreness on running biomechanics is via topical analgesic (Ellis et al., 2005). Topical analgesics, such as Biofreeze® work by attaching to the pain receptors that transmit a signal to the brain and relay a signal back to the muscle to protect the muscle by staying in a shortened position, affecting both force production and running biomechanics (Johar et al., 2012). The blocking of this signal should allow the individual to alleviate muscular pain and return muscle function and joint mechanics to pre-DOMS levels. However, the interactive effect of muscle soreness and a topical analgesic on the biomechanics of running remains unknown. A reduction in muscular pain related to DOMS can lead to improved performance in running, or at least more comfortability in daily living when dealing with DOMS. To date, there has been little research on the interactive effect of DOMS treated with a topical analgesic on running biomechanics.
Experiment protocol
Subjects: Twenty subjects aged 17-40 years will be recruited for the study. Participants will be considered recreational runners (minimum 17 years old, running 20km per week with no recent or current injuries). Written informed consent will be obtained from all subjects.
Experimental Procedures: Before any experimental procedures, participants will be a short familiarization session and anthropometric measurements that required for motion capture analysis will be taken. Next, participants will be allowed to warm up with their regular walk/run/stretching routine. After completion, participants will be instrumented with our biomechanics equipment (see below). Next, participants will run on a treadmill. Each running session will last for 5-10 minutes and participants will run at two different speeds (2 and 3 m/s) because the effects of eccentric exercise of both knee extensors and flexors on particular tempo-spatial parameters and knee kinematics of running are speed-dependent. Following the running session at both speeds, participants will perform our DOMS protocol (see below). At 48 hours post DOMS protocol, participants will return to the lab for the exact same running protocol as described above. Next, participants will have Biofreeze® (or placebo) applied (see below) and 15 minutes following the application, participants will again perform the running protocol (see timeline below)
Day 1:
- Familiarization with protocol and lab area
- Anthropometric Measurements
- Running kinematic analysis - BASELINE (EMG and Motion Capture)
- DOMS protocol (Decline treadmill running) Day 2: (48 hours post- DOMS protocol)
- Measurement of DOMS (Pressure Pain Threshold - see appendix, Subjective Analysis)
- DOMS-induced running kinematic analysis
- Biofreeze application / Control (Placebo) application
- Intervention running kinematic analysis
- EMG and Motion Capture throughout both sessions
DOMS protocol to induce pain: The DOMS protocol will consist of participants performing a 30-minute decline treadmill running protocol. The participant will first warm up for 5 minutes at an easy walking pace on a 0% grade. Once the participant is familiar with the treadmill and is prepared, the treadmill will be set to a -10% grade (decline) and participants will work up to 85% of their predicted heart rate maximum (PHRM). Once 85% PHRM is achieved, a 30-minute timer will begin and the participant will aim to maintain that level of intensity with monitoring by a spotter that will remain by the participants side. The participant will be clipped into the safety key on the treadmill at all times when on the treadmill.
Kinematics: Three-dimensional lower body kinematics will be tracked using a 10-camera Vicon motion capture system (Vicon, Oxford, UK). Individual markers will be placed over anatomical landmarks including, medial and lateral malleoli, foot (heel, distal metatarsals), medial and lateral condyles of the knee, greater trochanters of the hip, pelvis (anterior superior iliac spines, posterior superior iliac spines), and torso (xiphoid process, suprasternal notch, T10 vertebrae, C7 vertebrae, and a medio-inferior scapular landmark for positional identification). Additionally, custom-molded rigid bodies consisting of light weight reflective markers will be secured to the dorsal surface of the foot, mid-shank laterally, mid-thigh laterally, and pelvis posteriorly (sacral-iliac region). The rigid bodies will be used to track segment movement during experimental testing. A static calibration will determine the relationship between the rigid bodies and the calibration markers over the anatomical landmarks, and subsequently joint centers and segment coordinate systems. Markers will be attached by either a velcro-nylon strap, medical tape, or double-sided tape depending on each individual location.
Electromyography (EMG): Muscle activity will be recorded using surface electromyography (SEMG) and prior to electrode placement, standard preparations, including shaving the surface and cleansing the skin with alcohol will be performed (SOP 07 - Surface EMG). The investigators will require localized shaving on the specified locations below prior to electrode placement to improve the quality of our recording sites. A single-use, disposable razor will be used and if bleeding or razor burn occurs, this will become the priority, rather than continuing the protocol. SEMG will be recorded from 8 lower extremity muscles (bilaterally). Selected muscle groups will include:
- Knee extensors: vastus medialis, vastus lateralis, rectus femoris, vastus intermedius
- Knee flexors: biceps femoris, semimembranosus, semitendinosus
- Ankle plantar flexors: lateral gastrocnemius
Following electrode preparation that included shaving and scrubbing with alcohol, disposable bipolar Ag-AgCl surface electrodes (MediTrace 130, Kendall, Mansfield, MA, USA) will be placed over each muscle belly aligned with muscle fiber orientation with an interelectrode center-to-center distance of 2.5 cm. EMG will be band-pass filtered (10-1000 Hz) and differentially amplified (CMRR > 115 dB at 60 Hz; input impedance -10 GQ; Model AMT-8, Bortec Biomedical Ltd., Calgary, AB, Canada).
Following preparation, participants will perform a series of maximal voluntary contractions to normalize the EMG signals. Participants will perform isometric maximal knee flexion and extension contractions to normalize the EMG signals. All EMG data will be digitally recorded at a rate of 2048 Hz.
Pressure Pain Threshold: Pressure pain threshold will be used to assess muscle tenderness and is defined as the minimal amount of pressure that causes pain. A higher-pressure pain threshold indicates a lower amount of muscle tenderness. The pressure pain threshold will be measured for each participants' right quadricep at the beginning of each exercise session prior to any other testing. Participants will be instructed to say "yes" the instant they feel pain rather than pressure. With the participant in a relaxed standing position, the investigator will place the probe of the algometer into the midline of the right quadriceps midway between the iliac crest and the superior border of the patella. The investigator will gradually apply force at a constant rate of 50-60kPa s-1 until the participant indicates pain. Three trials, with a 30-second interval between measurement will be measured with an algometer with a 1.0cm2 stimulation area (Lafayette Instrument Company, Manual Muscle Tester, Model 01163, Lafayette, Indiana, USA.) and data will be recorded in kilograms/cm2 with a conversion to kilopascals (1kg/cm2=98.1 kPa). The average of three trials will be used for analysis.
Perceived Pain (Subjective Pain Analysis): Muscle soreness will also be measured using the BS-11 Numerical Rating Scale (NRS). The NRS will allow participants to express the amount of pain, in reference to muscle soreness they experienced. The NRS is an 11-point scale ranging 0-10, with 0 defined as "absolutely no muscle soreness", and 10 defined as "worst muscle soreness ever felt".
Rate of Perceived Exertion: A simplified scale to measure the rate of perceived exertion will be used (1-10, 1 being minimal effort and 10 being maximal effort sustainable for only a few seconds). This will be collected and averaged during every running portion of the study (Baseline, DOMS, Biofreeze/Control).
Biofreeze® (or placebo) Application: A topical cream will be applied over the quadriceps. If Biofreeze, 8ml of the topical analgesic will be applied over the muscle belly of the quadriceps. The mode of application will not involve any substantial force, pressure or rubbing, and thus any reflex activation will not be expected. This dose of Biofreeze®, is based upon the estimate that the average skin surface area over the quadriceps is approximately 1600cm2 and the recommended dosage of Biofreeze® of 1ml per 200cm. The same process will occur for the placebo cream. The researchers will be blind to application of either Biofreeze® or a placebo. Groups will be randomized into either the control or the experimental condition.
- Conditions
- Fatigue
- Being tested
- Biofreeze, Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreezeOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants receive the topical analgesic, Biofreeze. Receives: Other: Biofreeze |
| Placebo | Placebo comparator | Participants receive a placebo cream. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Temporal measures (variability)
Variability in stride measures throughout the repetition of the movement will be measured as a standard deviation.
Measured: 6 months
Secondary outcomes (2)
Muscle activity (average)
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.
Measured: 6 months
Muscle activity (maximum)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jun 2018
- Primary completion30 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Holmes, Brock University
- Investigators
- Mike Holmes, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516240
- Sponsor's protocol ID
- BrockURun
- Status last verified
- May 2020
- First submitted
- 24 Apr 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15064581Paquette 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.
PubMed 28276912Paschalis 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.
PubMed 16714113Tsatalas 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.
PubMed 20668871Ellis 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.
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.
PubMed 22666646Cheung 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.
PubMed 12617692
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatigue and Biofreeze® on the Biomechanics of Running
- ClinicalTrials.gov ID
- NCT03516240
- Acronym / sponsor ID
- BrockURun
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Delayed onset muscle soreness (DOMS) is a common complaint of many runners, from novice to expert. DOMS can affect the primary movers in locomotion, including but not limited to the hip flexors and extensors, knee flexors and extensors, and the ankle plantar flexors. When running with DOMS, hip, knee, and ankle mechanics can be affected in such that they may cause protective compensation in order to prevent further damage or attenuate pain in the affected musculature. One common occurrence is DOMS in the knee extensors following prolonged running. DOMS occurring in the knee extensors can greatly affect sagittal knee joint biomechanics (Dutto and Braun 2004; Paquette et al., 2017). More specifically, these changes in knee mechanics can increase knee stiffness at initial stance, resulting in an increase in vertical leg stiffness. This change in knee stiffness potentially serves as a protective compensation mechanism against lengthening of the knee extensors (Paschalis et al., 2007; Tsatalas et al., 2010). Changing running mechanics (as a result of DOMS, or fatigue) can potentially lead to an increased risk of running related injury.
One potential way to reduce or alleviate the influence of muscle soreness on running biomechanics is via topical analgesic (Ellis et al., 2005). Topical analgesics, such as Biofreeze® work by attaching to the pain receptors that transmit a signal to the brain and relay a signal back to the muscle to protect the muscle by staying in a shortened position, affecting both force production and running biomechanics (Johar et al., 2012). The blocking of this signal should allow the individual to alleviate muscular pain and return muscle function and joint mechanics to pre-DOMS levels. However, the interactive effect of muscle soreness and a topical analgesic on the biomechanics of running remains unknown. A reduction in muscular pain related to DOMS can lead to improved performance in running, or at least more comfortability in daily living when dealing with DOMS. To date, there has been little research on the interactive effect of DOMS treated with a topical analgesic on running biomechanics.
Experiment protocol
Subjects: Twenty subjects aged 17-40 years will be recruited for the study. Participants will be considered recreational runners (minimum 17 years old, running 20km per week with no recent or current injuries). Written informed consent will be obtained from all subjects.
Experimental Procedures: Before any experimental procedures, participants will be a short familiarization session and anthropometric measurements that required for motion capture analysis will be taken. Next, participants will be allowed to warm up with their regular walk/run/stretching routine. After completion, participants will be instrumented with our biomechanics equipment (see below). Next, participants will run on a treadmill. Each running session will last for 5-10 minutes and participants will run at two different speeds (2 and 3 m/s) because the effects of eccentric exercise of both knee extensors and flexors on particular tempo-spatial parameters and knee kinematics of running are speed-dependent. Following the running session at both speeds, participants will perform our DOMS protocol (see below). At 48 hours post DOMS protocol, participants will return to the lab for the exact same running protocol as described above. Next, participants will have Biofreeze® (or placebo) applied (see below) and 15 minutes following the application, participants will again perform the running protocol (see timeline below)
Day 1:
- Familiarization with protocol and lab area
- Anthropometric Measurements
- Running kinematic analysis - BASELINE (EMG and Motion Capture)
- DOMS protocol (Decline treadmill running) Day 2: (48 hours post- DOMS protocol)
- Measurement of DOMS (Pressure Pain Threshold - see appendix, Subjective Analysis)
- DOMS-induced running kinematic analysis
- Biofreeze application / Control (Placebo) application
- Intervention running kinematic analysis
- EMG and Motion Capture throughout both sessions
DOMS protocol to induce pain: The DOMS protocol will consist of participants performing a 30-minute decline treadmill running protocol. The participant will first warm up for 5 minutes at an easy walking pace on a 0% grade. Once the participant is familiar with the treadmill and is prepared, the treadmill will be set to a -10% grade (decline) and participants will work up to 85% of their predicted heart rate maximum (PHRM). Once 85% PHRM is achieved, a 30-minute timer will begin and the participant will aim to maintain that level of intensity with monitoring by a spotter that will remain by the participants side. The participant will be clipped into the safety key on the treadmill at all times when on the treadmill.
Kinematics: Three-dimensional lower body kinematics will be tracked using a 10-camera Vicon motion capture system (Vicon, Oxford, UK). Individual markers will be placed over anatomical landmarks including, medial and lateral malleoli, foot (heel, distal metatarsals), medial and lateral condyles of the knee, greater trochanters of the hip, pelvis (anterior superior iliac spines, posterior superior iliac spines), and torso (xiphoid process, suprasternal notch, T10 vertebrae, C7 vertebrae, and a medio-inferior scapular landmark for positional identification). Additionally, custom-molded rigid bodies consisting of light weight reflective markers will be secured to the dorsal surface of the foot, mid-shank laterally, mid-thigh laterally, and pelvis posteriorly (sacral-iliac region). The rigid bodies will be used to track segment movement during experimental testing. A static calibration will determine the relationship between the rigid bodies and the calibration markers over the anatomical landmarks, and subsequently joint centers and segment coordinate systems. Markers will be attached by either a velcro-nylon strap, medical tape, or double-sided tape depending on each individual location.
Electromyography (EMG): Muscle activity will be recorded using surface electromyography (SEMG) and prior to electrode placement, standard preparations, including shaving the surface and cleansing the skin with alcohol will be performed (SOP 07 - Surface EMG). The investigators will require localized shaving on the specified locations below prior to electrode placement to improve the quality of our recording sites. A single-use, disposable razor will be used and if bleeding or razor burn occurs, this will become the priority, rather than continuing the protocol. SEMG will be recorded from 8 lower extremity muscles (bilaterally). Selected muscle groups will include:
- Knee extensors: vastus medialis, vastus lateralis, rectus femoris, vastus intermedius
- Knee flexors: biceps femoris, semimembranosus, semitendinosus
- Ankle plantar flexors: lateral gastrocnemius
Following electrode preparation that included shaving and scrubbing with alcohol, disposable bipolar Ag-AgCl surface electrodes (MediTrace 130, Kendall, Mansfield, MA, USA) will be placed over each muscle belly aligned with muscle fiber orientation with an interelectrode center-to-center distance of 2.5 cm. EMG will be band-pass filtered (10-1000 Hz) and differentially amplified (CMRR > 115 dB at 60 Hz; input impedance -10 GQ; Model AMT-8, Bortec Biomedical Ltd., Calgary, AB, Canada).
Following preparation, participants will perform a series of maximal voluntary contractions to normalize the EMG signals. Participants will perform isometric maximal knee flexion and extension contractions to normalize the EMG signals. All EMG data will be digitally recorded at a rate of 2048 Hz.
Pressure Pain Threshold: Pressure pain threshold will be used to assess muscle tenderness and is defined as the minimal amount of pressure that causes pain. A higher-pressure pain threshold indicates a lower amount of muscle tenderness. The pressure pain threshold will be measured for each participants' right quadricep at the beginning of each exercise session prior to any other testing. Participants will be instructed to say "yes" the instant they feel pain rather than pressure. With the participant in a relaxed standing position, the investigator will place the probe of the algometer into the midline of the right quadriceps midway between the iliac crest and the superior border of the patella. The investigator will gradually apply force at a constant rate of 50-60kPa s-1 until the participant indicates pain. Three trials, with a 30-second interval between measurement will be measured with an algometer with a 1.0cm2 stimulation area (Lafayette Instrument Company, Manual Muscle Tester, Model 01163, Lafayette, Indiana, USA.) and data will be recorded in kilograms/cm2 with a conversion to kilopascals (1kg/cm2=98.1 kPa). The average of three trials will be used for analysis.
Perceived Pain (Subjective Pain Analysis): Muscle soreness will also be measured using the BS-11 Numerical Rating Scale (NRS). The NRS will allow participants to express the amount of pain, in reference to muscle soreness they experienced. The NRS is an 11-point scale ranging 0-10, with 0 defined as "absolutely no muscle soreness", and 10 defined as "worst muscle soreness ever felt".
Rate of Perceived Exertion: A simplified scale to measure the rate of perceived exertion will be used (1-10, 1 being minimal effort and 10 being maximal effort sustainable for only a few seconds). This will be collected and averaged during every running portion of the study (Baseline, DOMS, Biofreeze/Control).
Biofreeze® (or placebo) Application: A topical cream will be applied over the quadriceps. If Biofreeze, 8ml of the topical analgesic will be applied over the muscle belly of the quadriceps. The mode of application will not involve any substantial force, pressure or rubbing, and thus any reflex activation will not be expected. This dose of Biofreeze®, is based upon the estimate that the average skin surface area over the quadriceps is approximately 1600cm2 and the recommended dosage of Biofreeze® of 1ml per 200cm. The same process will occur for the placebo cream. The researchers will be blind to application of either Biofreeze® or a placebo. Groups will be randomized into either the control or the experimental condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: BiofreezeParticipants receive the topical analgesic, Biofreeze. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive a placebo cream. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age limits
- Average 20 kilometers running per week
Key exclusion criteria (1 listed)
- No recent or current injuries that would affect ability to run
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofreezeFollowing 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. | Other | Experimental |
| PlaceboFollowing 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. | Other | Placebo |
Primary outcome
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.
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.
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.
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.
Temporal measures (variability)
Time frame: 6 months
Variability in stride measures throughout the repetition of the movement will be measured as a standard deviation.
2 secondary outcomes
Muscle activity (average)
Time frame: 6 months
Muscle activity (maximum)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 15064581Dutto 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.
- Background: PubMed 28276912Paquette 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.
- Background: PubMed 16714113Paschalis 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.
- Background: PubMed 20668871Tsatalas 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.
- BackgroundEllis 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: PubMed 22666646Johar 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.
- Background: PubMed 12617692Cheung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Holmes, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofreeze in people with Fatigue, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint angles (degrees) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516240, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.