PNS Post-Marketing Study (STIM-Q PMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03877653|
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Information provided by (Responsible Party):
The purpose of this study is to assess the safety and effectiveness of the Freedom PNS (peripheral nerve stimulation) System for the treatment of chronic pain of peripheral nerve origin in trunk or limbs over a follow-up period of six months.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: Wireless neuromodulation||Not Applicable|
The purpose of this study is to assess the safety and effectiveness of the Freedom PNS (peripheral nerve stimulation) System for the treatment of chronic pain of peripheral nerve origin in trunk or limbs over a follow-up period of six months. Investigators will have the option to select one or more stimulators for stimulation over the enervated nerve(s). Stimulation programs include tonic stimulation, high frequency stimulation or burst stimulation, all of which may be selected via the same implant. Subjects will have chronic, intractable pain of the trunk or limbs, refractory to standard medical treatment; including unilateral or bilateral pain. 23 subjects will receive the Freedom PNS System and will be monitored for a total of six months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||PMS single group, open label|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation Via the Freedom Peripheral Nerve Stimulation (PNS) System for the Management of Chronic Trunk or Limb Pain|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Device: Wireless neuromodulation
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.
Primary Outcome Measures :
- Responder rate [ Time Frame: 6 months ]Percentage of patients with at least 50% pain relief experienced in the area of pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS
- Adverse Events [ Time Frame: 6 months ]Incidence and severity of device related adverse events during the study.
Secondary Outcome Measures :
- Pain VAS (Visual Analog scale) [ Time Frame: 6 months ]Percentage of pain relief experienced in the area of pain identified at baseline compared to 6 months post full implant of the Freedom PNS system as described on a 100 mm line scale (with 0= no pain; 100: worst pain imaginable)
- Pain Disability Index [ Time Frame: 6 months ]Improved function via the PDI questionnaires (7 questions) at 6 months compared to baseline. Answers on a scale of 0 (no disability) to 10 (worst disability)
- Patient Global Impression of change [ Time Frame: 6 months ]Patient Global impression of Change (PGIC) at 6 months compared to baseline. Scale from 1 (no change) to 7 (a great deal better) describing improvement with therapy
- Life Quality of life 5 lines [ Time Frame: 6 months ]Improved quality of life via the EQ-5D-5L questionnaire (5 questions) at 6 months. Answers on a scale of 1 (no problems) to 5 (unable)
- Change in Medication [ Time Frame: 6 months ]use of analgesics (dosage, units, schedule) at 6 months compared to baseline
No Contacts or Locations Provided