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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and immediately following the intervention
Awards & highlights
Study Summary
"This trial wants to see if how sensitive you are to pain at the beginning can predict how much pain relief you'll get from a massage that causes pain. They also want to compare the pain relief from
Who is the study for?
This trial is for individuals aged 18 to 60 who have been experiencing neck pain for at least three months, with a pain intensity of at least 4 out of 10 in the last day. It's not suitable for those with arm pain or other conditions that might affect their response to massage.Check my eligibility
What is being tested?
The study aims to see if how much pressure causes someone pain can predict relief from a painful massage and compares this relief to that from a non-painful massage or placing one's hand in cold water. Participants are randomly assigned to one of these three interventions.See study design
What are the potential side effects?
Potential side effects may include temporary increased neck discomfort, especially after the pain inducing massage. The cold water bath could cause brief numbness or tingling in the hand.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately following intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately following intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pressure Pain Threshold
Secondary outcome measures
Numeric Pain Rating Scale Movement Evoked Pain
Numeric Pain Rating Scale Resting Pain
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pain Inducing MassageExperimental Treatment1 Intervention
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.
Group II: Pain Free MassageActive Control1 Intervention
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.
Group III: Cold Water BathActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pain Inducing Massage
2018
N/A
~150
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,342 Previous Clinical Trials
715,617 Total Patients Enrolled
4 Trials studying Neck Pain
1,529 Patients Enrolled for Neck Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age restriction for potential participants in this study, specifically regarding individuals who are 65 years old or older?
"Participants between 18 and 60 years are eligible for this trial. Separate trials cater to individuals under 18 and those over 65, with a total of 57 available slots across all age groups."
Answered by AI
What is the largest group size allowed to enroll in this research study?
"Indeed, data on clinicaltrials.gov indicates that this trial is actively seeking participants. The study was first listed on April 8th, 2024 and last revised on April 12th, 2024. There are openings for 53 patients across a single site."
Answered by AI
Are there any available positions for patients in this ongoing clinical trial?
"Indeed, information from clinicaltrials.gov indicates that this investigation is currently seeking volunteers. The trial was initially disclosed on April 8th, 2024 and last revised on April 12th, 2024. It aims to enroll a total of 53 participants at a single site."
Answered by AI
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