Neck PainNCT06224829
Response to Massage in Neck Pain
A study testing Pain Inducing Massage, Pain Free Massage and Cold Water Bath in people with Neck Pain, run by University of Florida at 1 site in United States.
Trial summary
This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Pain Inducing Massage, Pain Free Massage and Cold Water Bath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years old
- Currently experiencing neck pain with or without arm pain
- Neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
- Neck pain for greater than or equal to 3 months
Who cannot join
- Non- English speaking
- Systemic medical conditions known to affect sensation (e.g. diabetes)
- History of neck surgery or fracture within the past 6 months
- Current history of chronic pain condition other than neck pain
- Diagnosis of cervical radiculopathy or cervical myelopathy
- History of whiplash
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- Currently using blood thinning medication
- Any blood clotting disorder such as hemophilia
- Any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Joel E Bialosky, PhD, 352-273-8636, bialosky@phhp.ufl.edu
Joel E Bialosky, PhD
About this study
Official title: Characterizing Responses to Massage in Individuals With Neck Pain
This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.
- Conditions
- Neck Pain
- Being tested
- Pain Inducing Massage, Pain Free Massage, Cold Water Bath
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Inducing MassageProcedure or surgery
60 seconds of direct pressure to the neck resulting in 5/10 pain . This will be repeated four times for a total of 240 seconds
Pain Free MassageProcedure or surgery
60 seconds of direct pressure to the neck resulting in 0/10 pain . This will be repeated four times for a total of 240 seconds
Cold Water BathProcedure or surgery
Participants will place their hand in a cold water bath maintained at 6 to 8 degrees Celsius for 60 seconds. This will be repeated four times for a total of 240 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Pain Inducing Massage | Experimental | Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 5/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable. Receives: Procedure: Pain Inducing Massage |
| Pain Free Massage | Active comparator | Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 0/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable. Receives: Procedure: Pain Free Massage |
| Cold Water Bath | Active comparator | Participants will place their non-dominant hand into water cooled by a refrigeration unit (NESLAB RTE 7 Digital One, Thermo Scientific Co., Massachusetts, USA) that circulates water continuously to maintain a constant 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 for a total immersion time of 240 seconds. Receives: Procedure: Cold Water Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
Pressure applied to the web space of the foot with a digital pressure algometer applied at 1 kg/s. Participants will be instructed to indicate when the sensation first changes from pressure to pain (pain threshold)
Measured: Baseline and immediately following the intervention
Secondary outcomes (2)
Numeric Pain Rating Scale Resting Pain
Participants will rate their "current" neck pain on a 0 to 100 scale with 0= no pain and 100= the most intense pain imaginable
Measured: Baseline, immediately following intervention
Numeric Pain Rating Scale Movement Evoked Pain
Participants will rate their neck pain on a 0 to 100 scale with 0= no pain and 100= the most intense pain imaginable during active cervical spine range of motion. The average rating across all motions (flexion, extension, left and right sidebend, left and right rotation) will be used in the analysis.
Measured: Baseline, immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start8 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224829
- Sponsor's protocol ID
- IRB202301891
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Responses to Massage in Individuals With Neck Pain
- ClinicalTrials.gov ID
- NCT06224829
- Acronym / sponsor ID
- IRB202301891
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Inducing Massage | Experimental | Procedure: Pain Inducing MassageParticipants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 5/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable. |
| Pain Free Massage | Active comparator | Procedure: Pain Free MassageParticipants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 0/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable. |
| Cold Water Bath | Active comparator | Procedure: Cold Water BathParticipants will place their non-dominant hand into water cooled by a refrigeration unit (NESLAB RTE 7 Digital One, Thermo Scientific Co., Massachusetts, USA) that circulates water continuously to maintain a constant 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 for a total immersion time of 240 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 60 years old
- Currently experiencing neck pain with or without arm pain
- Neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
- Neck pain for greater than or equal to 3 months
Key exclusion criteria (10 listed)
- Non- English speaking
- Systemic medical conditions known to affect sensation (e.g. diabetes)
- History of neck surgery or fracture within the past 6 months
- Current history of chronic pain condition other than neck pain
- Diagnosis of cervical radiculopathy or cervical myelopathy
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 Massage60 seconds of direct pressure to the neck resulting in 5/10 pain . This will be repeated four times for a total of 240 seconds | Procedure or surgery | Pain Inducing Massage |
| Pain Free Massage60 seconds of direct pressure to the neck resulting in 0/10 pain . This will be repeated four times for a total of 240 seconds | Procedure or surgery | Pain Free Massage |
| Cold Water BathParticipants will place their hand in a cold water bath maintained at 6 to 8 degrees Celsius for 60 seconds. This will be repeated four times for a total of 240 seconds. | Procedure or surgery | Cold Water Bath |
Primary outcome
Pressure Pain Threshold
Time frame: Baseline and immediately following the intervention
Pressure applied to the web space of the foot with a digital pressure algometer applied at 1 kg/s. Participants will be instructed to indicate when the sensation first changes from pressure to pain (pain threshold)
2 secondary outcomes
Numeric Pain Rating Scale Resting Pain
Time frame: Baseline, immediately following intervention
Numeric Pain Rating Scale Movement Evoked Pain
Time frame: Baseline, immediately following intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
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 Cold Water Bath in people with Neck 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Bialosky, PT, PhD (352-733-1162, bialosky@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: Baseline and immediately following the intervention). 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 30 Sep 2026.