PainNCT04625335
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
A study testing No Massage Protocol and Prophylactic Therapeutic Massage in people with Pain, run by Kyle Knight at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- No Massage Protocol and Prophylactic Therapeutic Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 1 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -generally healthy
Who cannot join
- pregnant
- smoker
- cold allergy
- Raynaud's disease
- cryophobia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- No Massage Protocol, Prophylactic Therapeutic Massage
- Keywords
- massage therapy, pain tolerance, pain threshold
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Massage ProtocolOther
Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.
Prophylactic Therapeutic MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Massage Protocol; Other: 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. Receives: Other: No Massage Protocol; Other: Prophylactic Therapeutic Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximated 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Sep 2015
- Primary completion2 Oct 2015
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyle Knight
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyle Knight, University of Kentucky
- Investigators
- Terry Malone, PT, EdD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625335
- Sponsor's protocol ID
- 15-0650-P1H
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8477405Cherkin 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.
PubMed 11322842Field 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.
PubMed 9443139Cherkin 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.
PubMed 12779300Hernandez-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.
PubMed 11264915Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20.
PubMed 10906914National 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 at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
- ClinicalTrials.gov ID
- NCT04625335
- Acronym / sponsor ID
- 15-0650-P1H
- Conditions
- Pain
- Keywords
- massage therapy, pain tolerance, pain threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kyle KnightUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 2 Oct 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Intervention First | Experimental | Other: No Massage Protocol, Other: Prophylactic Therapeutic MassageAdult, 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. |
| Group 2: Intervention Last | Experimental | Other: No Massage Protocol, Other: Prophylactic Therapeutic MassageAdult, 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -generally healthy
Key exclusion criteria (5 listed)
- pregnant
- smoker
- cold allergy
- Raynaud's disease
- cryophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Massage ProtocolParticipants did not receive therapeutic massage prior to completing the Cold Pressor Test. | Other | Group 1: Intervention First, Group 2: Intervention Last |
| Prophylactic Therapeutic MassageParticipants 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. | Other | Group 1: Intervention First, Group 2: Intervention Last |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 8477405Ferrell-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.
- Background: PubMed 11322842Cherkin 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.
- Background: PubMed 9443139Field 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.
- Background: PubMed 12779300Cherkin 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.
- Background: PubMed 11264915Hernandez-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.
- Background: PubMed 10906914Preyde M. Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ. 2000 Jun 27;162(13):1815-20.
- BackgroundNational 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.
- BackgroundKelly D. Therapeutic massage of the forearm and hand. Lecture presented at: PT615 Basic Clinical Skills; 2015; University of Kentucky, Lexington, KY.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Malone, PT, EdD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Massage Protocol and Prophylactic Therapeutic Massage in people with Pain, run by Kyle Knight at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Tolerance (time frame: Approximately 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625335, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.