HealthyNCT04108403
Mechanisms of Massage
A study testing Pain Inducing Massage, Pain Free Massage and Positive Expectation Instructional Set in people with Healthy and Pain, run by University of Florida at 1 site in United States.
Trial summary
The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Pain Inducing Massage, Pain Free Massage and Positive Expectation Instructional Set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 15 Dec 2021
- 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
Who cannot join
- non-English speaking
- 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
- any blood clotting disorder such as hemophilia
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. The researchers aim to extend these findings by understanding the influence of expectation on these findings.
Read the detailed description
Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established. In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia. Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant. Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.
- Being tested
- Pain Inducing Massage, Pain Free Massage, Positive Expectation Instructional Set, Negative Expectation Instructional Set
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Inducing MassageOther
A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.
Pain Free MassageOther
A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.
Positive Expectation Instructional SetOther
Participants will be instructed that the massage is effective for some people with neck pain.
Negative Expectation Instructional SetOther
Participants will be instructed that the massage is ineffective for some people with neck pain.
| Study group | Role | What they receive |
|---|---|---|
| Pain Inducing Massage and Positive Expectation Instructions | Experimental | A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. Receives: Other: Pain Inducing Massage; Other: Positive Expectation Instructional Set |
| Pain Inducing Massage and Negative Expectation Instructions | Active comparator | A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. Receives: Other: Pain Inducing Massage; Other: Negative Expectation Instructional Set |
| Pain Free Massage and Positive Expectation Instructions | Active comparator | A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. Receives: Other: Pain Free Massage; Other: Positive Expectation Instructional Set |
| Pain Free Massage and Negative Expectation Instructions | Active comparator | A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. Receives: Other: Pain Free Massage; Other: Negative Expectation Instructional Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
A computerized pressure algometer with a 1cm diameter rubber tip will be applied to the web space of the non-dominant foot. Participants are instructed to say "stop" so the stimulus can be terminated when the sensation first transitions from pressure to pain (threshold).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start31 Oct 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Bialosky, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108403
- Sponsor's protocol ID
- IRB201902417
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson AT, Bishop MD, Beneciuk JM, Tilley HE, Riley JL 3rd, Cruz-Almeida Y, Bialosky JE. Expectations affect pain sensitivity changes during massage. J Man Manip Ther. 2023 Apr;31(2):84-92. doi: 10.1080/10669817.2022.2118449. Epub 2022 Sep 7.
PubMed 36069038
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Massage
- ClinicalTrials.gov ID
- NCT04108403
- Acronym / sponsor ID
- IRB201902417
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 30 Sep 2019 (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.
The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. The researchers aim to extend these findings by understanding the influence of expectation on these findings.
Detailed description
Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established. In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia. Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant. Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pain Inducing Massage and Positive Expectation Instructions | Experimental | Other: Pain Inducing Massage, Other: Positive Expectation Instructional SetA myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. |
| Pain Inducing Massage and Negative Expectation Instructions | Active comparator | Other: Pain Inducing Massage, Other: Negative Expectation Instructional SetA myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a moderately painful massage (pain = 50/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. |
| Pain Free Massage and Positive Expectation Instructions | Active comparator | Other: Pain Free Massage, Other: Positive Expectation Instructional SetA myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a positive expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. |
| Pain Free Massage and Negative Expectation Instructions | Active comparator | Other: Pain Free Massage, Other: Negative Expectation Instructional SetA myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck. Participants in this arm will receive a negative expectation instructional set followed by a pain free massage (pain = 0/100). Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pain Free
Key exclusion criteria (6 listed)
- non-English speaking
- 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
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 MassageA pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times. | Other | Pain Inducing Massage and Negative Expectation Instructions, Pain Inducing Massage and Positive Expectation Instructions |
| Pain Free MassageA pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times. | Other | Pain Free Massage and Negative Expectation Instructions, Pain Free Massage and Positive Expectation Instructions |
| Positive Expectation Instructional SetParticipants will be instructed that the massage is effective for some people with neck pain. | Other | Pain Free Massage and Positive Expectation Instructions, Pain Inducing Massage and Positive Expectation Instructions |
| Negative Expectation Instructional SetParticipants will be instructed that the massage is ineffective for some people with neck pain. | Other | Pain Free Massage and Negative Expectation Instructions, Pain Inducing Massage and Negative Expectation Instructions |
Primary outcome
Pressure Pain Threshold
Time frame: 1 hour
A computerized pressure algometer with a 1cm diameter rubber tip will be applied to the web space of the non-dominant foot. Participants are instructed to say "stop" so the stimulus can be terminated when the sensation first transitions from pressure to pain (threshold).
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 16 Sep 2022.
- Derived from this study: PubMed 36069038Wilson AT, Bishop MD, Beneciuk JM, Tilley HE, Riley JL 3rd, Cruz-Almeida Y, Bialosky JE. Expectations affect pain sensitivity changes during massage. J Man Manip Ther. 2023 Apr;31(2):84-92. doi: 10.1080/10669817.2022.2118449. Epub 2022 Sep 7.
- 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, PT, 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 Positive Expectation Instructional Set in people with Healthy and 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 1 inclusion and 6 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 16 Sep 2022. 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?
Pressure Pain Threshold (time frame: 1 hour). 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 NCT04108403, which also lists 1 linked publication.
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 16 Sep 2022.