RECRUITING

Freedom-1 Study for Chronic Knee Pain

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

To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.

Official Title

Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation

Quick Facts

Study Start:2021-09-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03877653

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

Niek Vanquathem, BA
CONTACT
0032 492 69 22 23
niekv@stimwavefreedom.com

Study Locations (Sites)

Western Clinical Research
Placentia, California, 92870
United States
Colorado Pain Care, LLC
Denver, Colorado, 80222
United States
Holy Cross Hospital, Inc
Fort Lauderdale, Florida, 33308
United States
Florida Joint Care Institute
Trinity, Florida, 34655
United States
Southern Pain and research
Jasper, Georgia, 30143
United States
Vista Clinical Research/Summit Spine & Joint Centers
Newnan, Georgia, 30265
United States
Desert Orthopaedic Center
Las Vegas, Nevada, 89149
United States
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, 45459
United States
Premier Pain Treatment
Loveland, Ohio, 45140
United States
Kettering Health
Miamisburg, Ohio, 45429
United States
Austin Orthopedic Institute
Austin, Texas, 78759
United States
Performance pain and sports medicine
Houston, Texas, 77027
United States
Advanced Spine and Pain Center
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: Curonix 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 Date2021-09-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-09-01
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • PNS
  • Chronic
  • Pain
  • Wireless
  • Neuromodulation
  • knee
  • osteoarthritic
  • peripheral nerve stimulation
  • infra patellar saphenous

Additional Relevant MeSH Terms

  • Osteoarthritic Knee Pain