Status:
COMPLETED
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
Lead Sponsor:
GiMer Medical
Collaborating Sponsors:
China Medical University Hospital
Conditions:
Failed Back Surgery Syndrome
Complex Regional Pain Syndrome (CRPS)
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial ...
Detailed Description
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial ...
Eligibility Criteria
Inclusion
- Age ≧20 and ≦75
- Have a symptom of complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), lower limb pain with or without lower back pain with a diagnosis related to spinal lesion and pain history of \>6 months.
- Have an average pain score \>5 by Visual Analogue Scale (VAS) on inclusion.
- Has failed to achieve adequate pain relief from prior pharmacologic treatments.
- In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure
- The subject is willing and able to comply with the procedure and requirements of this trial.
- The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.
Exclusion
- Have evidence of a mental or psychological condition that affects pain perception and has difficulty/disability performing objective pain assessment, or have previously failed mental or psychological assessments administered by a psychiatrist that may be deemed to indicate the subject's lack of suitability for participation in this study.
- Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination.
- Be on anticoagulant medication with INR \>1.5 or platelet count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus (DM).
- Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
- Pain medication(s) dosages(s) are not stable for at least 30 days.
- Has previously failed spinal cord stimulation therapy.
- Currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
- Has pain only within a cervical or thoracic distribution.
- Have a current diagnosis of cancer with active symptoms
- Have a known terminal illness with life expectancy less than one year
- Have a systematic or local infection
- Currently has an indwelling device that may pose an increased risk of infection.
- Be pregnant or breast feeding
- Have a medical history of drug or alcohol addiction within the past 2 years.
- Participation in any investigational study in the last 30 days or current enrollment in any trial.
- Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
- Be a prisoner.
Key Trial Info
Start Date :
March 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03285113
Start Date
March 3 2017
End Date
February 5 2018
Last Update
January 22 2021
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan