Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00487981
Other study ID # SCS0206
Secondary ID
Status Terminated
Phase Phase 4
First received June 15, 2007
Last updated February 21, 2012
Start date February 2007
Est. completion date September 2008

Study information

Verified date February 2012
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.


Description:

The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes

- Have chronic neuropathic pain for at least 12 months

- Be 18 years of age or older

- Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition

- Be an appropriate candidate for SCS therapy and have already decided to use the Precision system

- Be willing and able to comply with all study related procedures and visits

- Be capable of reading and understanding patient information materials and giving written informed consent

Exclusion Criteria:

- Are a smoker

- Have any other chronic pain condition likely to confound evaluation of study endpoints

- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Precision Spinal Cord Stimulation
Stimulation on throughout the study once device is implanted

Locations

Country Name City State
United States Deaconess Pain Management Center Evansville Indiana

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Rating at 6 Months Post Activation Compared to Baseline 6 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care