NCT04625335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 5, 2020

Last Update Submit

November 10, 2020

Conditions

Keywords

massage therapypain tolerancepain threshold

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group 1: Intervention First

EXPERIMENTAL

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 ProtocolOther: Prophylactic Therapeutic Massage

Group 2: Intervention Last

EXPERIMENTAL

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 ProtocolOther: Prophylactic Therapeutic Massage

Interventions

Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.

Group 1: Intervention FirstGroup 2: Intervention Last

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.

Group 1: Intervention FirstGroup 2: Intervention Last

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • generally healthy

You may not qualify if:

  • pregnant
  • smoker
  • cold allergy
  • Raynaud's disease
  • cryophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (8)

  • 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.

    PMID: 8477405BACKGROUND
  • 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.

    PMID: 11322842BACKGROUND
  • 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.

    PMID: 9443139BACKGROUND
  • 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.

    PMID: 12779300BACKGROUND
  • 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.

    PMID: 11264915BACKGROUND
  • Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20.

    PMID: 10906914BACKGROUND
  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Terry Malone, PT, EdD

    University of Kentucky

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

September 1, 2015

Primary Completion

October 2, 2015

Study Completion

March 1, 2016

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations