HealthyNCT03490474
Pain Modulatory Profiles in Massage for Healthy Participants
A study testing Pain Inducing Massage, Pain Free Massage and Coldpressor in people with Healthy and Musculoskeletal Pain, run by University of Florida at 1 site in United States.
Trial summary
One in ten adults experience widespread pain. Neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually. Massage is a common manual therapy intervention for individuals with musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Musculoskeletal Pain
- What is being tested?
- Pain Inducing Massage, Pain Free Massage and Coldpressor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 12 Dec 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pain free
- blood pressure under 140/90 mmHg
- ability of therapist to locate necessary trigger points on participant
Who cannot join
- blood pressure over 140/90 mmHg
- inability of therapist to locate necessary trigger points on participant
- systemic medical condition known to affect sensation (i.e. diabetes)
- regular use of prescription pain medication to manage pain
- current or history of chronic pain condition
- currently using blood thinning medication
Show all 9Show fewer
- any blood clotting disorder such as hemophilia
- any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise
- non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
One in ten adults experience widespread pain. Neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually.
Massage is a common manual therapy intervention for individuals with musculoskeletal pain. However, the mechanisms of massage are not well established. Also, the conditioned pain modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain inhibitory process in which pain sensitivity is lessened in response to a remotely applied painful stimulus.
This study will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm.
Read the detailed description
Conditioned pain modulation (CPM) is the physical manifestation of the diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions and it is a predictor for the development of chronic pain.
Massage is a common manual therapy intervention for individuals with musculoskeletal pain. Greater changes in pain sensitivity occur following pain inducing massage suggesting a mechanism dependent upon the efficiency of the conditioned pain modulation response.
The study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. Healthy participants will be randomly assigned to receive a pain inducing massage, a pain free massage, or participate in a coldpressor task. Pre-and post intervention pain sensitivity including conditioned pain modulation will be assessed. The study team will determine if analgesia induced by massage is similar to the conditioned pain modulation paradigm and compare changes in pain sensitivity between groups.
Previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation. However, this study will be the first to systematically investigate if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm. Furthermore, this study will be the first to determine the association between baseline conditioned pain modulation and massage related hypoalgesia.
- Conditions
- Healthy, Musculoskeletal Pain
- Being tested
- Pain Inducing Massage, Pain Free Massage, Coldpressor
- Keywords
- conditioned pain modulation (CPM), diffuse noxious inhibitory control (DNIC), massage, hypoalgesia
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Inducing MassageOther
Participants will receive 60 seconds of manual pressure applied to one myofascial trigger point so the participant rates the pain = 5/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
Pain Free MassageOther
Participants will receive 60 seconds of light touch applied to one myofascial trigger point so the participant rates the pain = 0/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
ColdpressorOther
Participants will place their non-dominant hand into water cooled by a refrigeration unit temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Pain Inducing Massage | Experimental | Participants will receive manual pressure applied to one myofascial trigger point. Receives: Other: Pain Inducing Massage |
| Pain Free Massage | Active comparator | Participants will receive light touch applied to one myofascial trigger point. Receives: Other: Pain Free Massage |
| Coldpressor | Placebo comparator | Participants will place hand into water cooled to 6 degrees Celsius (males) or 8 degrees Celsius (females). Receives: Other: Coldpressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pressure Pain Threshold
Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful
Measured: 2 hours
Secondary outcomes (5)
Change from baseline in Thermal Pain Threshold and Tolerance
Temperature at which ascending thermal stimulus first changes from warm to painful and maximum temperature tolerated
Measured: 2 hours
Change from baseline in Pressure Pain Tolerance
Pressure in kilograms at which ascending pressure is no longer tolerated
Measured: 2 hours
Change from baseline in Ramp and Hold
Participants will rate their pain using a 101 point mechanical visual analog scale to thermal stimuli of 45, 47, 49, and 50 degree Celsius each of 5 seconds duration will be applied to the forearm and to the muscle on the side of the neck
Measured: 2 hours
Change from baseline in Temporal Summation
Participants will rate their pain using a 0 to 10 numeric rating scale to a train of 10 50 degree Celsius heat pulses will be applied to the skin in the plantar surface of the hand.
Measured: 2 hours
Change from baseline in Conditioned Pain Modulation
Pressure in kilograms at which ascending pressure stimulus applied to the foot first changes from pressure to painful both prior to and immediately following immersion of the opposite hand in a cold water bath
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start16 Apr 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Bialosky, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490474
- Sponsor's protocol ID
- IRB201800213
- Status last verified
- Dec 2018
- First submitted
- 21 Mar 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Modulatory Profiles in Massage for Healthy Participants
- ClinicalTrials.gov ID
- NCT03490474
- Acronym / sponsor ID
- IRB201800213
- Conditions
- Healthy, Musculoskeletal Pain
- Keywords
- conditioned pain modulation (CPM), diffuse noxious inhibitory control (DNIC), massage, hypoalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 6 Apr 2018 (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.
One in ten adults experience widespread pain. Neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually.
Massage is a common manual therapy intervention for individuals with musculoskeletal pain. However, the mechanisms of massage are not well established. Also, the conditioned pain modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain inhibitory process in which pain sensitivity is lessened in response to a remotely applied painful stimulus.
This study will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm.
Detailed description
Conditioned pain modulation (CPM) is the physical manifestation of the diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions and it is a predictor for the development of chronic pain.
Massage is a common manual therapy intervention for individuals with musculoskeletal pain. Greater changes in pain sensitivity occur following pain inducing massage suggesting a mechanism dependent upon the efficiency of the conditioned pain modulation response.
The study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. Healthy participants will be randomly assigned to receive a pain inducing massage, a pain free massage, or participate in a coldpressor task. Pre-and post intervention pain sensitivity including conditioned pain modulation will be assessed. The study team will determine if analgesia induced by massage is similar to the conditioned pain modulation paradigm and compare changes in pain sensitivity between groups.
Previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation. However, this study will be the first to systematically investigate if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm. Furthermore, this study will be the first to determine the association between baseline conditioned pain modulation and massage related hypoalgesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Inducing Massage | Experimental | Other: Pain Inducing MassageParticipants will receive manual pressure applied to one myofascial trigger point. |
| Pain Free Massage | Active comparator | Other: Pain Free MassageParticipants will receive light touch applied to one myofascial trigger point. |
| Coldpressor | Placebo comparator | Other: ColdpressorParticipants will place hand into water cooled to 6 degrees Celsius (males) or 8 degrees Celsius (females). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pain free
- blood pressure under 140/90 mmHg
- ability of therapist to locate necessary trigger points on participant
Key exclusion criteria (9 listed)
- blood pressure over 140/90 mmHg
- inability of therapist to locate necessary trigger points on participant
- systemic medical condition known to affect sensation (i.e. diabetes)
- regular use of prescription pain medication to manage pain
- current or history of chronic pain condition
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 |
|---|---|---|
| Pain Inducing MassageParticipants will receive 60 seconds of manual pressure applied to one myofascial trigger point so the participant rates the pain = 5/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times. | Other | Pain Inducing Massage |
| Pain Free MassageParticipants will receive 60 seconds of light touch applied to one myofascial trigger point so the participant rates the pain = 0/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times. | Other | Pain Free Massage |
| ColdpressorParticipants will place their non-dominant hand into water cooled by a refrigeration unit temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times. | Other | Coldpressor |
Primary outcome
Change from baseline in Pressure Pain Threshold
Time frame: 2 hours
Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful
5 secondary outcomes
Change from baseline in Thermal Pain Threshold and Tolerance
Time frame: 2 hours
Change from baseline in Pressure Pain Tolerance
Time frame: 2 hours
Change from baseline in Ramp and Hold
Time frame: 2 hours
Change from baseline in Temporal Summation
Time frame: 2 hours
Change from baseline in Conditioned Pain Modulation
Time frame: 2 hours
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 13 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Joel Bialosky, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Inducing Massage, Pain Free Massage and Coldpressor in people with Healthy and Musculoskeletal Pain, run by University of Florida 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 3 inclusion and 9 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 13 Dec 2018. 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. Some participants in this study may receive a placebo. 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 from baseline in Pressure Pain Threshold (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2018.