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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04625335
Other study ID # 15-0650-P1H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date March 1, 2016

Study information

Verified date November 2020
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 1, 2016
Est. primary completion date October 2, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: -generally healthy Exclusion Criteria: - pregnant - smoker - cold allergy - Raynaud's disease - cryophobia

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Kyle Knight

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Kelly D. Therapeutic massage of the forearm and hand. Lecture presented at: PT615 Basic Clinical Skills; 2015; University of Kentucky, Lexington, KY.

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.

Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain Tolerance 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
Primary Change in Pain Threshold 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
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