Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit (NCT03157544) | Clinical Trial Compass
TerminatedNot Applicable
Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit
Stopped: Recruitment issues
United States35 participantsStarted 2017-03-01
Plain-language summary
The purpose of this project is to determine the effect of a multimodal non-pharmacological Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of individuals suffering from an acute pain episode of chronic neck and/or low back pain over a 3-week duration.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Over age 18 and report experiencing average daily musculoskeletal pain of moderate intensity (\>3/10) in the neck or low back for greater than 4 weeks.
Exclusion Criteria:
* Report any indication for medical clearance prior to engaging in moderate intensity exercise or if they have any other health limitations to engaging in moderate exercise.
* Additional exclusion criteria are the individual is unable to complete any of the data collection protocols, has previously been diagnosed with schizophrenia, dementia or is mentally incapable of providing informed consent or report a previous allergic reaction to kinesiotape or menthol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
Timeframe: 3 (Baseline, 1 week, 3 weeks)
2
Change in visual analog scale (VAS) of pain at 3 weeks
Timeframe: 3 (Baseline, 1 week, 3 weeks)
3
Change in Timed performance of functional tasks at 3 weeks
Timeframe: 3 (Baseline, 1 week, 3 weeks)
Trial details
NCT IDNCT03157544
SponsorSport and Spine Rehab Clinical Research Foundation