Freedom-1 Study for Chronic Knee Pain

Conditions

• Osteoarthritic Knee Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Sep 1, 2021

Status verified

Feb 2025

Primary completion

Oct 31, 2025

Completion

Jun 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Interventional
  Single arm, active stimulation
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Responder rate [ Time Frame: 1 month ]

Central Contacts

• Niek Vanquathem, BA
  0032 492 69 22 23
  [email protected]

Locations (13)

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