Clinical trial NCT05896878: The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Official title: The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Chronic
Opioid Dependence
Opioid Use
Inflammation Chronic
Lead sponsor: Hudson Medical
Sponsor class: OTHER
Collaborators: name: Ethos Research & Development
First posted: 2023-06-09
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effects on Foundation Pain Index (FPI) scores
timeFrame: 3 months
Secondary outcomes:
measure: Pain Improvements
timeFrame: 3 months
measure: Functional Improvements
timeFrame: 3 months
measure: Reduced Opioid Dependency
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hudson Medical
state: New York
Study officials:
affiliation: Medical Director, Hudson Medical
name: Jonathann Kuo, MD
role: PRINCIPAL_INVESTIGATOR
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