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The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients

Sponsor
Hudson Medical (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05896878
Collaborator
Ethos Research & Development (Industry)
20
Enrollment
1
Location
1
Arm
2
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Root.Health Dietary Supplement
 Phase 1

Detailed Description

This study aims to utilize pain-specific abnormal biomarkers to evaluate how daily supplementation with Root.Health, a plant-based dietary supplement, affects FPI urine screening scores in chronic opioid-consuming pain patients. Analyzing the effect of Root.Health supplementation on pain-specific biomarkers through changes in FPI scores may expand our understanding of the degree to which these biomarkers may correlate to the underlying biologic processes involved in chronic pain creation. While widespread identification of such abnormalities may prove to have profound impacts on the future prevention, diagnosis, and treatment of pain, this investigation only intends to evaluate the effect of Root.Health on patient's urine levels of abnormal biomarkers. A previous validation study of the urine assay used in FPI screening demonstrated that an estimated 86% of patients reporting pain have at least one abnormal pain-related biomarker. The plant-based ingredients of the Root.Health supplement have been previously studied in the context of biochemical abnormalities that drive pain development, and this study is designed to characterize the mechanism by which these ingredients act to maintain biochemical processes which normally attenuate pain. As such, this study is not intended to evaluate Root.Health's ability to diagnose, cure, mitigate, treat, or prevent any disease.

The compounds included Root.Health supplements were carefully selected based on methodological review of current scientific evidence describing their roles in supporting innate physiological processes that attenuate biochemical abnormalities driving pain development. The investigators hypothesize that the plant-based compounds included in Root.Health will reduce the levels of abnormal pain biomarkers in chronic pain patients, as measured by a change in FPI score from baseline, based on literature which suggests that these compounds may attenuate biochemical abnormalities involved in causative pain mechanisms by supporting specific markers of cellular health (i.e normal activity of inflammatory pathways, oxidative stress capacity, production of pain-related neurotransmitters, and micronutrient status).

This is an open-label, prospective, observational pilot study. The investigators will be using a single group assignment intervention model with one group of 20 subjects. The primary outcome of this study is to evaluate Foundational Pain Index scores following a 3-month daily supplementation course with Root.Health in an opiate-using chronic pain patient population at 1-month and 3-months. The secondary objective of this study is to evaluate if daily supplementation with Root.Health for a 3-month study period affects Brief Pain Inventory (BPI) Short Form and Oswestry Disability Index (ODI) scores and/or opiate consumption in this patient population. The total study duration for each eligible participant is 4 months, which will include 5 study points: initial in-person study visit, 1-week in-person follow up visit (where study participants will receive supplements), and 3 virtual follow up visits at 1-month, 2-months and 3-months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study is a prospective, open-label, non randomized evaluation of daily supplementation with Root.Health, a plant-based anti-inflammatory dietary supplement, on Foundation Pain Index (FPI) scores in a chronic opiate patient population. The daily supplement is offered without charge to study participants. All patients are counseled and consented per established protocol as per established IRB requirements. This study will enroll 20 total patients. The details of the study design, patient demographics, description of the intervention method, and statistical tests performed are described.This study is a prospective, open-label, non randomized evaluation of daily supplementation with Root.Health, a plant-based anti-inflammatory dietary supplement, on Foundation Pain Index (FPI) scores in a chronic opiate patient population. The daily supplement is offered without charge to study participants. All patients are counseled and consented per established protocol as per established IRB requirements. This study will enroll 20 total patients. The details of the study design, patient demographics, description of the intervention method, and statistical tests performed are described.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daily Supplement Treatment

Following study recruitment and obtaining consent, participants will complete a baseline urine test. The FPI is a simple urine test from Ethos Laboratories that screens for 11 biomarkers that are more likely to contribute to symptoms of pain.

Dietary Supplement: Root.Health Dietary Supplement
The Root.Health supplement is composed of six plant-based compounds with established roles in supporting innate physiological processes which are implicated in pain: tetrohydrocurcumin, ergothioneine, dihydroberberine, trans-resveratrol, ginger root extract, and methylcobalamin. Participants will take the provided supplement twice per day for the entire study duration in addition to pain management treatment protocols the participants currently follow.

Outcome Measures

Primary Outcome Measures

  1. Effects on Foundation Pain Index (FPI) scores [3 months]

    To determine if a 3-month Root.Health supplementation course changes urine levels of Foundation Pain Index (FPI) scores mechanistic pain biomarkers in an opiate-using chronic pain population. Previous validation studies have demonstrated that higher FPI scores, represented by a greater number of abnormal biomarkers, indicate abnormal biochemical function is more likely to contribute to painful symptoms. Lower FPI scores, represented by a lower number of abnormal biomarkers, indicate biochemical function is unremarkable and is therefore less likely to be a contributor to painful symptoms. As such, the investigators will only include study participants with baseline FPI scores between 20-100 to select a study population in which abnormal biochemical functioning is more likely to be contributing to chronic pain symptoms. Scores between 0-20 are considered unremarkable.

Secondary Outcome Measures

  1. Pain Improvements [3 months]

    To evaluate if a 3-month Root.Health supplementation regimen changes Brief Pain Inventory (BPI) Short Form scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each item of the BPI, patients select a whole number on scale of 0-10, where 0 indicates no pain and 10 indicates worst possible pain. Lower scores are associated with less severe episodes of pain.

  2. Functional Improvements [3 months]

    To evaluate if a 3-month Root.Health supplementation regimen changes Oswestry Disability Index (ODI) scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each question on the ODI, patient select the one whole number that describes how much the pain has interfered with the listed activities. The ODI is scored on a scale of 0-10, where 0 indicates no interference thus being able to do all activities and 10 indicates complete interference so the patient is unable to do the activity. Lower scores are associated with less severe episodes of pain.

  3. Reduced Opioid Dependency [3 months]

    To evaluate if a 3-month Root.Health supplementation regimen affects opiate consumption habits from time of study enrollment in an opiate-using chronic pain population. This information will be gathered through subjective patient interviews at each month's follow up, inquiring about how often the patient is taking a prescribed medication. The study participants will report if they have continued their opioid medications at regular intervals as prescribed, or if they have taken less or more than the maximum prescribed dose.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Participants must be 18 years of age or older

  • At least two (2) or more symptoms of moderate or higher severity musculoskeletal pain for at least one year prior to study enrollment

  • At least 3 months of opioid use for pain management at time of study enrollment

Exclusion Criteria:

  • under 18 years of age

  • participants who are pregnant or breastfeeding at time of study recruitment

  • To reduce the likelihood of a study population whose recreational choices may affect the study endpoints, the investigators will screen potential participants during the enrollment phase using exclusion criteria based on health history, including recreational opiate drug use.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hudson Medical New York New York United States 10014

Sponsors and Collaborators

  • Hudson Medical
  • Ethos Research & Development

Investigators

  • Principal Investigator: Jonathann Kuo, MD, Medical Director, Hudson Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jonathann Kuo, MD, Principial Investigator, Hudson Medical
ClinicalTrials.gov Identifier:
NCT05896878
Other Study ID Numbers:
  • BRANY #22-02-797-993
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Inflammation
Chronic Pain
Opioid-Related Disorders

Study Results

No Results Posted as of Jun 13, 2023