- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625335
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
November 10, 2020 updated by: Kyle Knight
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
-generally healthy
Exclusion Criteria:
- pregnant
- smoker
- cold allergy
- Raynaud's disease
- cryophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.
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.
|
Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Tolerance
Time Frame: 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.
|
Approximately 3 minutes
|
Change in Pain Threshold
Time Frame: 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.
|
Approximated 3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Terry Malone, PT, EdD, University of Kentucky
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003 Jun 3;138(11):898-906. doi: 10.7326/0003-4819-138-11-200306030-00011.
- Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8. doi: 10.1001/archinte.161.8.1081.
- Ferrell-Torry AT, Glick OJ. The use of therapeutic massage as a nursing intervention to modify anxiety and the perception of cancer pain. Cancer Nurs. 1993 Apr;16(2):93-101.
- Field T, Hernandez-Reif M, Taylor S, Quintino O, Burman I. Labor pain is reduced by massage therapy. J Psychosom Obstet Gynaecol. 1997 Dec;18(4):286-91. doi: 10.3109/01674829709080701.
- Hernandez-Reif M, Field T, Krasnegor J, Theakston H. Lower back pain is reduced and range of motion increased after massage therapy. Int J Neurosci. 2001;106(3-4):131-45. doi: 10.3109/00207450109149744.
- Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20.
- National Institute on Drug Abuse; Johns Hopkins University. Study of the treatment of experimental pain in opioid dependent persons on methadone or buprenorphine maintenance. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2015-[cited 2015 Aug 19]. Available from: https://clinicaltrials.gov/ct2/show/NCT01642030 NLM Identifier: NCT01642030.
- Kelly D. Therapeutic massage of the forearm and hand. Lecture presented at: PT615 Basic Clinical Skills; 2015; University of Kentucky, Lexington, KY.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2015
Primary Completion (ACTUAL)
October 2, 2015
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
November 5, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (ACTUAL)
November 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-0650-P1H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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