An interventional study of Relief Study Product Usage in Pain, Nociceptive Pain and Neuropathic Pain, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 457 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Radicle Science is the lead sponsor of 64 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Relief Product Form 1 - control
Dietary Supplement: Relief Study Product Usage
Relief Product Form 1 - active product 1
Dietary Supplement: Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks
Change in pain interference
Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A \[scale 6-30; with higher scores corresponding to greater pain interference\]
Time frame: 4 weeks
Change in neuropathic pain
Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A \[scale 5-25; with higher scores corresponding to greater neuropathic pain\]
Time frame: 4 weeks
Change in nociceptive pain
Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A \[scale 5-25; with higher scores corresponding to greater nociceptive pain\]
Time frame: 4 weeks
Change in pain intensity
Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A \[scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain'\]
Time frame: 4 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A \[scale 4-20; with higher scores corresponding to more severe anxiety\]
Time frame: 4 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A \[scale 4-20; with higher scores corresponding to more severe sleep disturbance\]
Time frame: 4 weeks
Minimal clinically important difference (MCID) in pain interference
Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A
Time frame: 4 weeks
Minimal clinically important difference (MCID) in neuropathic pain
Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A
Time frame: 4 weeks
Minimal clinically important difference (MCID) in nociceptive pain
Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A
Time frame: 4 weeks
Minimal clinically important difference (MCID) in pain intensity
Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A
Time frame: 4 weeks
Change in energy (fatigue)
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A \[scale 4-20; with higher scores corresponding to greater fatigue\]
Time frame: 4 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A \[scale 4-20; with higher scores corresponding to greater cognitive function\]
Time frame: 4 weeks
Change in emotional distress
Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A \[scale 4-20; with higher scores corresponding to greater levels of emotional distress\]
Time frame: 4 weeks
Change in sexual interest
Mean difference in sexual interest as assessed by PROMIS Sexual Interest 2.0 \[scale 2-10; with higher scores corresponding to greater interest in sexual activity\]
Time frame: 4 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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