Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT04625335
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2020-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Tolerance', 'timeFrame': 'Approximately 3 minutes', 'description': '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.'}, {'measure': 'Change in Pain Threshold', 'timeFrame': 'Approximated 3 minutes', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['massage therapy', 'pain tolerance', 'pain threshold'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '8477405', 'type': 'BACKGROUND', '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.'}, {'pmid': '11322842', 'type': 'BACKGROUND', 'citation': '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': '9443139', 'type': 'BACKGROUND', '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. doi: 10.3109/01674829709080701.'}, {'pmid': '12779300', 'type': 'BACKGROUND', '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. doi: 10.7326/0003-4819-138-11-200306030-00011.'}, {'pmid': '11264915', 'type': 'BACKGROUND', '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. doi: 10.3109/00207450109149744.'}, {'pmid': '10906914', 'type': 'BACKGROUND', 'citation': 'Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Kelly D. Therapeutic massage of the forearm and hand. Lecture presented at: PT615 Basic Clinical Skills; 2015; University of Kentucky, Lexington, KY.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n-generally healthy\n\nExclusion Criteria:\n\n* pregnant\n* smoker\n* cold allergy\n* Raynaud's disease\n* cryophobia"}, 'identificationModule': {'nctId': 'NCT04625335', 'briefTitle': 'Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold', 'orgStudyIdInfo': {'id': '15-0650-P1H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Intervention First', 'description': '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.', 'interventionNames': ['Other: No Massage Protocol', 'Other: Prophylactic Therapeutic Massage']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Intervention Last', 'description': '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.', 'interventionNames': ['Other: No Massage Protocol', 'Other: Prophylactic Therapeutic Massage']}], 'interventions': [{'name': 'No Massage Protocol', 'type': 'OTHER', 'description': 'Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.', 'armGroupLabels': ['Group 1: Intervention First', 'Group 2: Intervention Last']}, {'name': 'Prophylactic Therapeutic Massage', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Group 1: Intervention First', 'Group 2: Intervention Last']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Terry Malone, PT, EdD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyle Knight', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kyle Knight', 'investigatorAffiliation': 'University of Kentucky'}}}}