Analgesic Induces Similar Upper and Lower Body Pain Pressure Threshold Increases

NCT04677985 | Completed

• 1 other identifier: 20192544
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Muscle Soreness; Tendon Injuries

Keywords

menthol; musculoskeletal; tendons; lower back

Outcome Measures

Primary Outcomes (1)

• Pain pressure threshold

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

  Applied 15 minutes after application of topical analgesic or placebo.

Study Arms (2)

Menthol based topical analgesic

EXPERIMENTAL

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

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.

Combination Product: Menthol based topical analgesic

Interventions

Menthol based topical analgesic COMBINATION_PRODUCT

Topical analgesic or placebo was applied to upper and lower body muscles and tendons and pain pressure threshold was measured with a handheld algometer.

Also known as: Menthol smelling cream with no analgesic

Menthol based topical analgesic; Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy individuals with no musculoskeletal or neural pathologies.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1C 5S7, Canada

Location

MeSH Terms

Conditions

Acute Pain; Myalgia; Tendon Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Wounds and Injuries

Study Officials

• David G Behm, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo and analgesic applications were identified by numbers which were only revealed after the statistical analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Research Professor

Model Details: Random allocation of the application of a menthol based topical analgesic versus a placebo.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: May 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 14, 2020 onwards

Locations

CA (1)