RECRUITING

Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.

Official Title

Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study

Quick Facts

Study Start:2021-05-05
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04580732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Shanice Saunders
CONTACT
888-691-0585
contact@micronmed.com
Marlene Pena
CONTACT
888-691-0585
contact@micronmed.com

Study Locations (Sites)

Seva Medical
Lewisville, Texas, 75057
United States

Collaborators and Investigators

Sponsor: MiniStim LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-05
Study Completion Date2025-11

Study Record Updates

Study Start Date2021-05-05
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Knee Pain