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Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases

Primary Purpose

Pain, Acute, Muscle Soreness, Tendon Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Menthol based topical analgesic
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring menthol, musculoskeletal, tendons, lower back

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Healthy individuals with no musculoskeletal or neural pathologies.

Exclusion Criteria:

1. Musculoskeletal or neural pathologies / injuries in the year before the experiment.

Sites / Locations

  • Memorial University of Newfoundland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Menthol based topical analgesic

Placebo

Arm Description

Menthol based topical analgesic was applied to a variety of upper and lower body muscles and tendons.

Placebo (cream that smelled like menthol) was applied to a variety of upper and lower body muscles and tendons.

Outcomes

Primary Outcome Measures

Pain pressure threshold
Measures the force applied to the muscle or tendon till pain is detected.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2020
Last Updated
December 18, 2020
Sponsor
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT04677985
Brief Title
Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases
Official Title
Menthol-based Topical Analgesic Induces Similar Upper and Lower Body Increases in Pain Pressure Threshold: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Muscle Soreness, Tendon Injuries
Keywords
menthol, musculoskeletal, tendons, lower back

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Random allocation of the application of a menthol based topical analgesic versus a placebo.
Masking
ParticipantInvestigator
Masking Description
Placebo and analgesic applications were identified by numbers which were only revealed after the statistical analysis.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menthol based topical analgesic
Arm Type
Experimental
Arm Description
Menthol based topical analgesic was applied to a variety of upper and lower body muscles and tendons.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (cream that smelled like menthol) was applied to a variety of upper and lower body muscles and tendons.
Intervention Type
Combination Product
Intervention Name(s)
Menthol based topical analgesic
Other Intervention Name(s)
Menthol smelling cream with no analgesic
Intervention Description
Topical analgesic or placebo was applied to upper and lower body muscles and tendons and pain pressure threshold was measured with a handheld algometer.
Primary Outcome Measure Information:
Title
Pain pressure threshold
Description
Measures the force applied to the muscle or tendon till pain is detected.
Time Frame
Applied 15 minutes after application of topical analgesic or placebo.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Healthy individuals with no musculoskeletal or neural pathologies. Exclusion Criteria: 1. Musculoskeletal or neural pathologies / injuries in the year before the experiment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Behm, PhD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5S7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Excel sheet data can be obtained upon request.
IPD Sharing Time Frame
December 14, 2020 onwards

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Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases

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