Pain, AcuteNCT04677985
Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases
A study testing Menthol based topical analgesic in people with Pain, Acute and Muscle Soreness, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Background: Both health professionals and consumers use menthol-based topical analgesics extensively for the temporary relief of pain from musculoskeletal ailments or injury. However, there are no reports of differences in the pain pressure threshold (PPT) or the relative effectiveness of topical analgesics to reduce… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Muscle Soreness, Tendon Injuries
- What is being tested?
- Menthol based topical analgesic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2019to 31 Dec 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy individuals with no musculoskeletal or neural pathologies.
Who cannot join
- 1. Musculoskeletal or neural pathologies / injuries in the year before the experiment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1C 5S7
About this study
Official title: Menthol-based Topical Analgesic Induces Similar Upper and Lower Body Increases in Pain Pressure Threshold: A Randomized Trial
Background: Both health professionals and consumers use menthol-based topical analgesics extensively for the temporary relief of pain from musculoskeletal ailments or injury. However, there are no reports of differences in the pain pressure threshold (PPT) or the relative effectiveness of topical analgesics to reduce pain in the upper and lower body muscles and tendons. Objectives: The objective of this study was to investigate whether differences existed in PPT and relative pain attenuation associated with a menthol based topical analgesic over a variety of upper and lower body muscles and tendons. Design: Randomized allocation, controlled, intervention study. Method: Sixteen participants (10 females and 6 males), who were tested on their dominant or non-dominant side. The order of specific muscle / tendon testing was also randomized, which included upper body (middle deltoid, biceps brachii, and lateral epicondylar tendon) and lower body locations (quadriceps, hamstrings, gastrocnemius, lumbo-sacral erector spinae muscles, and patellar and Achilles tendons). PPT was monitored before and 15-minutes following the application of a menthol based topical analgesic.
Read the detailed description
Experimental Design Using random allocation (slip of paper chosen from a box by one of the researchers), participants were either tested on their dominant or non-dominant side. Limb dominance was determined by the participants' self-report of the preferred hand used for writing/throwing (upper extremity) and for kicking a ball (lower extremity). Further, randomization was used to determine which muscle groups would be tested first: upper body versus lower body, and the order of muscle testing. The tested upper body limb muscles consisted of the middle deltoid, and biceps brachii. The lower body muscle groups consisted of the quadriceps, hamstrings, and gastrocnemius. In order to compare sensitivity differences between muscles and tendons, the patellar tendon, and Achilles tendon were also tested. In addition, as tennis elbow (lateral epicondylitis/epicondylosis) is a common injury [40], the lateral epicondylar tendon was also evaluated. The lower back was tested using the lumbo-sacral erector spinae muscles.
The pre-testing consisted of obtaining PPT (without topical analgesic application) using a handheld algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA), from each muscle or tendon. The algometer was a hand-held muscle tester with a range of 0-300 pounds (136.1 kilograms) that consisted of a padded disc with a surface area of 1.7 cm2 attached to a microprocessor-control unit that measures peak force (pounds or kilograms). The unit has a digital readout for peak-applied pressure and provides a built-in calibration routine that verifies a valid calibration. The pain threshold was defined as the minimum pressure that induced pain [15]. Participants were instructed to provide a verbal report as soon as the quality of sensation changed from pressure to pain [15,16] at which point the algometer was removed. This study chose to measure the PPT via a pressure algometer as it has been shown to be a clinically and experimentally reliable method to assess pain [16,23,35]. The middle of the muscle belly for the biceps brachii, middle deltoid, hamstrings (biceps femoris), quadriceps (rectus femoris), and gastrocnemius was used. The measurement sites for the patella tendon and lateral epicondylar tendon were 1 cm distal from the bony origin. For the Achilles tendon, the measurement was taken at one third of the distance of the tendon length distal to its insertion. There were three readings from each testing position with a 5-second rest period between each reading.
Intervention The intervention involved the application of 4% menthol-based Biofreeze® (Performance Health, Akron, Ohio) to the muscles and tendons immediately following the pre-testing. Based on prior recommendations [22,45,32] varying volumes of the topical analgesic were applied in reference to the surface area of the muscle. The previously cited investigators recommended 1ml per 200 cm2 of muscle surface area. No significant force (light stroking actions to apply the analgesic) was used for the application of the menthol-based topical analgesic.
- Conditions
- Pain, Acute, Muscle Soreness, Tendon Injuries
- Being tested
- Menthol based topical analgesic
- Keywords
- menthol, musculoskeletal, tendons, lower back
- Medical subject headings
- Acute Pain, Myalgia, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol based topical analgesicCombination product
Also called Menthol smelling cream with no analgesic
Topical analgesic or placebo was applied to upper and lower body muscles and tendons and pain pressure threshold was measured with a handheld algometer.
| Study group | Role | What they receive |
|---|---|---|
| Menthol based topical analgesic | Experimental | Menthol based topical analgesic was applied to a variety of upper and lower body muscles and tendons. Receives: Combination Product: Menthol based topical analgesic |
| Placebo | Placebo comparator | Placebo (cream that smelled like menthol) was applied to a variety of upper and lower body muscles and tendons. Receives: Combination Product: Menthol based topical analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Measures the force applied to the muscle or tendon till pain is detected.
Measured: Applied 15 minutes after application of topical analgesic or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 May 2019
- Primary completion30 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Crossover
- Model description
- Random allocation of the application of a menthol based topical analgesic versus a placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David George Behm, Memorial University of Newfoundland
- Investigators
- David G Behm, PhD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677985
- Sponsor's protocol ID
- 20192544
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel sheet data can be obtained upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menthol-based Topical Analgesic Induces Similar Upper and Lower Body Increases in Pain Pressure Threshold: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04677985
- Acronym / sponsor ID
- 20192544
- Conditions
- Pain, Acute, Muscle Soreness, Tendon Injuries
- Keywords
- menthol, musculoskeletal, tendons, lower back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Dec 2020 (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.
Background: Both health professionals and consumers use menthol-based topical analgesics extensively for the temporary relief of pain from musculoskeletal ailments or injury. However, there are no reports of differences in the pain pressure threshold (PPT) or the relative effectiveness of topical analgesics to reduce pain in the upper and lower body muscles and tendons. Objectives: The objective of this study was to investigate whether differences existed in PPT and relative pain attenuation associated with a menthol based topical analgesic over a variety of upper and lower body muscles and tendons. Design: Randomized allocation, controlled, intervention study. Method: Sixteen participants (10 females and 6 males), who were tested on their dominant or non-dominant side. The order of specific muscle / tendon testing was also randomized, which included upper body (middle deltoid, biceps brachii, and lateral epicondylar tendon) and lower body locations (quadriceps, hamstrings, gastrocnemius, lumbo-sacral erector spinae muscles, and patellar and Achilles tendons). PPT was monitored before and 15-minutes following the application of a menthol based topical analgesic.
Detailed description
Experimental Design Using random allocation (slip of paper chosen from a box by one of the researchers), participants were either tested on their dominant or non-dominant side. Limb dominance was determined by the participants' self-report of the preferred hand used for writing/throwing (upper extremity) and for kicking a ball (lower extremity). Further, randomization was used to determine which muscle groups would be tested first: upper body versus lower body, and the order of muscle testing. The tested upper body limb muscles consisted of the middle deltoid, and biceps brachii. The lower body muscle groups consisted of the quadriceps, hamstrings, and gastrocnemius. In order to compare sensitivity differences between muscles and tendons, the patellar tendon, and Achilles tendon were also tested. In addition, as tennis elbow (lateral epicondylitis/epicondylosis) is a common injury [40], the lateral epicondylar tendon was also evaluated. The lower back was tested using the lumbo-sacral erector spinae muscles.
The pre-testing consisted of obtaining PPT (without topical analgesic application) using a handheld algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA), from each muscle or tendon. The algometer was a hand-held muscle tester with a range of 0-300 pounds (136.1 kilograms) that consisted of a padded disc with a surface area of 1.7 cm2 attached to a microprocessor-control unit that measures peak force (pounds or kilograms). The unit has a digital readout for peak-applied pressure and provides a built-in calibration routine that verifies a valid calibration. The pain threshold was defined as the minimum pressure that induced pain [15]. Participants were instructed to provide a verbal report as soon as the quality of sensation changed from pressure to pain [15,16] at which point the algometer was removed. This study chose to measure the PPT via a pressure algometer as it has been shown to be a clinically and experimentally reliable method to assess pain [16,23,35]. The middle of the muscle belly for the biceps brachii, middle deltoid, hamstrings (biceps femoris), quadriceps (rectus femoris), and gastrocnemius was used. The measurement sites for the patella tendon and lateral epicondylar tendon were 1 cm distal from the bony origin. For the Achilles tendon, the measurement was taken at one third of the distance of the tendon length distal to its insertion. There were three readings from each testing position with a 5-second rest period between each reading.
Intervention The intervention involved the application of 4% menthol-based Biofreeze® (Performance Health, Akron, Ohio) to the muscles and tendons immediately following the pre-testing. Based on prior recommendations [22,45,32] varying volumes of the topical analgesic were applied in reference to the surface area of the muscle. The previously cited investigators recommended 1ml per 200 cm2 of muscle surface area. No significant force (light stroking actions to apply the analgesic) was used for the application of the menthol-based topical analgesic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Random allocation of the application of a menthol based topical analgesic versus a placebo.
| Arm | Type | Receives |
|---|---|---|
| Menthol based topical analgesic | Experimental | Combination Product: Menthol based topical analgesicMenthol based topical analgesic was applied to a variety of upper and lower body muscles and tendons. |
| Placebo | Placebo comparator | Combination Product: Menthol based topical analgesicPlacebo (cream that smelled like menthol) was applied to a variety of upper and lower body muscles and tendons. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy individuals with no musculoskeletal or neural pathologies.
Key exclusion criteria (1 listed)
- 1. Musculoskeletal or neural pathologies / injuries in the year before the experiment.
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 |
|---|---|---|
| Menthol based topical analgesicAlso: Menthol smelling cream with no analgesicTopical analgesic or placebo was applied to upper and lower body muscles and tendons and pain pressure threshold was measured with a handheld algometer. | Combination product | Menthol based topical analgesic, Placebo |
Primary outcome
Pain pressure threshold
Time frame: Applied 15 minutes after application of topical analgesic or placebo.
Measures the force applied to the muscle or tendon till pain is detected.
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 21 Dec 2020.
- Individual participant dataSharing planned: Yes. Excel sheet data can be obtained upon request.
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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.
David G Behm, PhD principal investigator
Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol based topical analgesic in people with Pain, Acute and Muscle Soreness, run by Memorial University of Newfoundland 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 1 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 21 Dec 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?
Pain pressure threshold (time frame: Applied 15 minutes after application of topical analgesic or placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2020.