Neuropathic Pain, Nociceptive Pain, Pain
Conditions
Brief summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes
Detailed description
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
Interventions
DIETARY_SUPPLEMENTRelief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
Intervention model description
Participants will be stratified based on gender at birth then randomized to one of the study arms
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities * Resides in the United States * Endorses pain as a primary issue (desire for less pain) * Selects their desire for less pain and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Exclusion criteria
* Reports being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid physical shipping address * Reports a diagnosis of liver or kidney disease * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Lack of reliable daily access to the internet * Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs * Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain interference | 4 weeks | Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A \[scale 6-30; with higher scores corresponding to greater pain interference\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in feelings of anxiety | 4 weeks | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A \[scale 4-20; with higher scores corresponding to more severe anxiety\] |
| Minimal clinically important difference (MCID) in pain interference | 4 weeks | Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A |
| Minimal clinically important difference (MCID) in neuropathic pain | 4 weeks | Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A |
| Minimal clinically important difference (MCID) in nociceptive pain | 4 weeks | Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A |
| Minimal clinically important difference (MCID) in pain intensity | 4 weeks | Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A |
| Change in neuropathic pain | 4 weeks | Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A \[scale 5-25; with higher scores corresponding to greater neuropathic pain\] |
| Change in nociceptive pain | 4 weeks | Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A \[scale 5-25; with higher scores corresponding to greater nociceptive pain\] |
| Change in pain intensity | 4 weeks | Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A \[scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain'\] |
| Change in sleep disturbance | 4 weeks | Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A \[scale 4-20; with higher scores corresponding to more severe sleep disturbance\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in emotional distress | 4 weeks | Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A \[scale 4-20; with higher scores corresponding to greater levels of emotional distress\] |
| Change in sexual interest | 4 weeks | Mean difference in sexual interest as assessed by PROMIS Sexual Interest 2.0 \[scale 2-10; with higher scores corresponding to greater interest in sexual activity\] |
| Change in cognitive function | 4 weeks | Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A \[scale 4-20; with higher scores corresponding to greater cognitive function\] |
| Change in energy (fatigue) | 4 weeks | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A \[scale 4-20; with higher scores corresponding to greater fatigue\] |
Countries
United States
Outcome results
None listed