Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold

Sponsor
Kyle Knight (Other)
Overall Status
Completed
CT.gov ID
NCT04625335
Collaborator
(none)
14
1
2
6
2.3

Study Details

Study Description

Brief Summary

Therapeutic massage has been thought to reduce anxiety and increase relaxation in human patients.This study is meant to determine the immediate effects of therapeutic massage on pain tolerance and threshold.

Condition or Disease Intervention/Treatment Phase
  • Other: No Massage Protocol
  • Other: Prophylactic Therapeutic Massage
N/A

Detailed Description

Patients participated in two trials of a pain stimulus test that measured pain threshold and pain tolerance. One trial was titled "Massage Protocol" and the other, "No-Massage Protocol." During the "Massage Protocol," they received a therapeutic massage to the forearm before participating in the pain stimulus test. During the "No-Massage Protocol" they did not receive a massage before participating in the pain stimulus test. Their pain threshold and tolerance for both trials were compared against each other. Each patient was randomized as to which protocol they participated in first.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Oct 2, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Intervention First

Adult, healthy volunteers will receive the intervention (prophylactic therapeutic massage) before completing the Cold Pressor Test. Following the crossover, these participants will then complete the Cold Pressor Test without prior massage.

Other: No Massage Protocol
Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.

Other: Prophylactic Therapeutic Massage
Participants received a 5 minute prophylactic therapeutic massage prior to completing the Cold Pressor Test. The massage was completed distally-to-proximally in the following order: superficial strokes to the entire forearm, deep strokes to the entire forearm, one-handed palmar kneading of the entire forearm with participant's forearm stabilized by the massager's the other hand, bilateral thumb kneading of the forearm in strips until the entire forearm was addressed, bilateral transverse thumb motions over palmar surface of the hand, single thumb kneading of thenar and hypothenar eminences simultaneously, bilateral thumb kneading to the dorsum of hand, deep stroking to the entire forearm, and superficial stroking to the entire forearm.

Experimental: Group 2: Intervention Last

Adult, healthy volunteers will complete the Cold Pressor Test without prior massage. After crossover, they will receive the intervention (prophylactic therapeutic massage) before completing the Cold Pressor Test.

Other: No Massage Protocol
Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.

Other: Prophylactic Therapeutic Massage
Participants received a 5 minute prophylactic therapeutic massage prior to completing the Cold Pressor Test. The massage was completed distally-to-proximally in the following order: superficial strokes to the entire forearm, deep strokes to the entire forearm, one-handed palmar kneading of the entire forearm with participant's forearm stabilized by the massager's the other hand, bilateral thumb kneading of the forearm in strips until the entire forearm was addressed, bilateral transverse thumb motions over palmar surface of the hand, single thumb kneading of thenar and hypothenar eminences simultaneously, bilateral thumb kneading to the dorsum of hand, deep stroking to the entire forearm, and superficial stroking to the entire forearm.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Tolerance [Approximately 3 minutes]

    Pain tolerance is measured as using the Cold Pressor Test. It is calculated as the amount of time elapsed between submersion of the hand in cold water and removal due to intolerance of the stimulus. Data will be reported as the change in pain tolerance between massage and no massage.

  2. Change in Pain Threshold [Approximated 3 minutes]

    Pain threshold is measured using the Cold Pressor Test. It is calculated as the amount of time elapsed between submersion of the hand in cold water and the first report of pain. Data will be reported as the change in pain threshold between massage and no massage.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

-generally healthy

Exclusion Criteria:
  • pregnant

  • smoker

  • cold allergy

  • Raynaud's disease

  • cryophobia

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40536

Sponsors and Collaborators

  • Kyle Knight

Investigators

  • Study Director: Terry Malone, PT, EdD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kyle Knight, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier:
NCT04625335
Other Study ID Numbers:
  • 15-0650-P1H
First Posted:
Nov 12, 2020
Last Update Posted:
Nov 12, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kyle Knight, Principal Investigator, University of Kentucky

Study Results

No Results Posted as of Nov 12, 2020