Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy

This study has been withdrawn prior to enrollment.
(Investigator decided to withdraw participation in the study)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00414804
First received: December 20, 2006
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

The primary objective of this study is to compare the efficacy of SCS using the Precision implantable neurostimulation device and conventional medical treatment (nerve blocks + physical therapy) in subjects with recently-diagnosed Complex Regional Pain Syndrome (CRPS) after some more conservative treatments have failed. There are significant numbers of patients with CRPS in whom conventional treatment is ineffective and SCS is used only as a last resort. If SCS is effective earlier in the treatment continuum, it would provide a much needed treatment alternative and increase awareness of the utility of SCS for this indication. It is also possible that early intervention with SCS may limit disease progression.


Condition Intervention
Complex Regional Pain Syndrome
Chronic Pain
Pain
Device: Precision SCS
Procedure: Nerve Blocks and PT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation (SCS) Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • The primary endpoint is reduction in baseline levels of pain; [ Time Frame: 12-weeks post SCS treatment compared to Nerve Blocks+PT ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2006
Arms Assigned Interventions
Active Comparator: Spinal Cord Stimulation (SCS) Group
Spinal Cord Stimulation (SCS) Treatment Group
Device: Precision SCS
Precision Spinal Cord Stimulation (SCS) Therapy
Active Comparator: Nerve Blocks and PT Procedure: Nerve Blocks and PT
Pain therapy utilizing Nerve Blocks with Physical Therapy

Detailed Description:

Standard medical treatment for moderate/severe chronic pain of Complex Regional Pain Syndrome (CRPS) is usually inadequate. Sympathetic nerve blocks with local anesthetics are commonly employed and in some cases can be an effective option. Nerve blocks are not consistently effective, however, and their utility is further compromised by a short duration of relief.

CRPS is among the pain etiologies that can be managed via Spinal Cord Stimulation (SCS); this option can be quite effective at providing long-term pain relief for the management of CRPS. Importantly, SCS is not usually attempted until other treatment options, including nerve blocks and ablative procedures, have failed to produce adequate pain relief. No studies have been performed to date comparing SCS to a series of nerve block injections plus physical therapy. In this context, it may be prudent to consider SCS earlier in the treatment continuum. Instead of obliging a CRPS patient to cycle through numerous rounds of injections, optimal clinical pain management may be attained through early implantation of an SCS system. This prospective clinical study will compare the relative efficacy of SCS with that of repeated nerve blocks and physical therapy in a group of subjects with moderate-to-severe CRPS pain.

Patients who have never had invasive treatments for CRPS pain will be randomized to either a series of sympathetic blocks plus physical therapy or SCS. Changes in pain, disability, and quality of life outcomes will be assessed at follow up visits as well as incidence and outcomes of subjects electing to cross over to the alternate treatment option. This study will generate insight into the best pain management strategies for CRPS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be diagnosed with chronic CRPS with intractable neuropathic pain of moderate to severe intensity within the last 3-6 months.
  • Have failed initial treatment for CRPS, such as physical therapy alone, oral medications, and/or steroids.
  • Be 18 years of age or older.
  • Be an appropriate candidate for the surgical procedures required for SCS.
  • 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:

  • Have had any unsuccessful back or spine surgery that currently causes pain.
  • Have had any treatment for CRPS other than physical therapy, oral medications, or steroids.
  • Have any evidence of neurologic instability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414804

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Thomas Simopoulos, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00414804     History of Changes
Other Study ID Numbers: SCS0805
Study First Received: December 20, 2006
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Pain
Neurostimulation

Additional relevant MeSH terms:
Chronic Pain
Complex Regional Pain Syndromes
Syndrome
Autonomic Nervous System Diseases
Disease
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Pathologic Processes
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014