Clinical Trials Logo
  1. Home
  2. Chronic Pain
  3. NCT05278533

Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain

Chronic Pain Clinical Trial

Official title:
A Prospective, Randomized, Double-blind, Placebo-controlled, Early-stage Study to Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on Quality of Life in Adults With Chronic Pain

Clinical Trial Summary

This study is a randomized, double-blind, placebo controllled parallel design study to evaluate the use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on quality of life in adults with chronic pain. Eligible participants that provide informed consent and pass the screening visit procedures will be randomized in a 4:1 ratio to active product or placebo at the baseline visit (V2) and will return after 3 and 6 weeks of supplementation for study assessments.

Clinical Trial Description

A newly developed biomarker test panel, named the Foundation Pain Index (FPI), has been demonstrated to have applications in the potential medical care of individuals living with chronic pain. The research to date has demonstrated a nutritional link to pain amongst other potential causes or collaterals related to pain. The current research points to nutritional deficiencies, metabolic abnormalities and oxidative stressors as all being related to pain and potential pain management. Preliminary research has found that the novel biomarker testing platform allows for the treating physician to utilize non-opioid means for helping to manage quality of life and pain medication usage (opioid and non-opioid). Using the FPI, a systems biology approach will be taken to identify potential biomarkers related to pain and pain management. The present study is designed to determine if individuals with chronic pain can benefit from the FPI and the nutritional supplement BioPlete™ A total of 30 participants will be randomized in a 4:1 ratio for the study, with 24 participants in the Test Product arm and 6 participants in the placebo arm. The study duration for this trial can last up to a total of approximately 2.5 months (73 days) in duration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05278533
Study type Interventional
Source Ethos Research & Development
Contact
Status Completed
Phase N/A
Start date November 2, 2021
Completion date October 5, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain