Freedom-1 Study for Chronic Knee Pain
ConditionOsteoarthritic Knee Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCuronix LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Wireless neuromodulation
DeviceA 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InterventionalExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
1 monthSecondary outcomes
1
Mankoski pain scale
The Mankoski Pain Scale is a numerical scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. As pain is a subjective experience and individuals may interpret the severity of their pain differently, the MPS includes descriptions of each level of pain intensity to standardize the pain interpretation across subjects enrolled in this study.
Time frame
1 month2
Koos Jr
The KOOS assesses patient knee pain, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, useful for assessing changes in knee pathology over time, with or without treatment
Time frame
1 month3
Global Perceived Effect scales (GPES)
Patient satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best) Scale from 1 (no change) to 7 (a great deal better) describing improvement with therapy
Time frame
1 month4
McGill Short Form (SF-MPQ-2)
The SF-MPQ-2 is a patient self-reported depression and pain quality questionnaire consisting of 22 questions, with all questions scored on a scale of 0 to 10. Answers on a scale of 0 (none) to 10 (worst possible)
Time frame
1 monthOther outcomes
1
Treadmill
Pain-free walking time and distance on the treadmill
Time frame
1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Curonix LLC
Lead sponsor
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
Source ClinicalTrials.gov