Freedom-1 Study for Chronic Knee Pain

NCT03877653 | Recruiting FDA Device

• 2 other identifiers: 30-00946Freedom-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Osteoarthritic Knee Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Responder rate

  A. Percentage of patients with at least 50% improvement in the knee pain identified at baseline compared to 3 months post full implant of the StimQ PNS System pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS

  1 month

Secondary Outcomes (10)

• Mankoski pain scale

  1 month

• Koos Jr

  1 month

• Global Perceived Effect scales (GPES)

  1 month

• McGill Short Form (SF-MPQ-2)

  1 month

• Neuropathic pain questionnaire (DN4)

  baseline

Other Outcomes (1)

• Treadmill

  1 month

Study Arms (2)

Interventional

EXPERIMENTAL

Single arm, active stimulation

Device: Wireless neuromodulation

Placebo

PLACEBO COMPARATOR

When receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation. Sites will not have access to WaveCrest programmer. Study devices can only be programmed by Stimwave representatives.

Device: Wireless neuromodulation

Interventions

Wireless neuromodulation DEVICE

A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.

Interventional; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS \>6/10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and/or oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (\> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.

You may not qualify if:

• xi. Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his/her enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.

Sponsors & Collaborators

• Curonix LLC: lead
• Texas Institute for Pain and spine: collaborator
• Performance Pain and Sports Medicine PLLC: collaborator
• Holy Cross Hospital, Inc: collaborator
• Colorado pain Care, LLC: collaborator
• Advanced Spine and Pain: collaborator
• Desert Orthopaedic Institute: collaborator
• Vista Clinical Research: collaborator
• Premier Pain Treatment: collaborator
• Florida Joint Pain Institute: collaborator
• Austin Orthopedic Institute: collaborator
• Kettering Health: collaborator

Study Sites (13)

Western Clinical Research

Placentia, California, 92870, United States

RECRUITING

Colorado Pain Care, LLC

Denver, Colorado, 80222, United States

RECRUITING

Holy Cross Hospital, Inc

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Florida Joint Care Institute

Trinity, Florida, 34655, United States

RECRUITING

Southern Pain and research

Jasper, Georgia, 30143, United States

RECRUITING

Vista Clinical Research/Summit Spine & Joint Centers

Newnan, Georgia, 30265, United States

RECRUITING

Desert Orthopaedic Center

Las Vegas, Nevada, 89149, United States

RECRUITING

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, 45459, United States

RECRUITING

Premier Pain Treatment

Loveland, Ohio, 45140, United States

RECRUITING

Kettering Health

Miamisburg, Ohio, 45429, United States

RECRUITING

Austin Orthopedic Institute

Austin, Texas, 78759, United States

RECRUITING

Performance pain and sports medicine

Houston, Texas, 77027, United States

RECRUITING

Advanced Spine and Pain Center

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Niek Vanquathem, BA

CONTACT

0032 492 69 22 23; niekv@stimwavefreedom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A sponsor representative will open the sealed envelopes and assign groups. Investigators and research staff will be blinded to assignment of high frequency or sham. Randomization assignment will be documented post-implant but will be filed separately in a document locker, which will only be available to a sponsor representative until the time of unblinding. When receiving active stimulation, devices will be programmed to deliver electrical stimulation below perception threshold. Stimulation waveforms delivered above perception threshold have the potential to unblind subjects to their assignments. When receiving sham stimulation, devices will be programmed to not actively deliver electrical stimulation but still deplete battery life to maintain blinding. Subjects will have to recharge batteries similar to receiving active stimulation. Sites will not have access to the programmer. Study devices can only be programmed by Stimwave representatives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: placebo-controlled double blinded randomized clinical trial

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: March 18, 2019
• Study Start: September 1, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)