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Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy

Primary Purpose

Complex Regional Pain Syndrome, Chronic Pain, Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Precision SCS
Nerve Blocks and PT
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring Pain, Neurostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Spinal Cord Stimulation (SCS) Group

    Nerve Blocks and PT

    Arm Description

    Spinal Cord Stimulation (SCS) Treatment Group

    Outcomes

    Primary Outcome Measures

    The primary endpoint is reduction in baseline levels of pain;

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2006
    Last Updated
    February 13, 2012
    Sponsor
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00414804
    Brief Title
    Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy
    Official Title
    Spinal Cord Stimulation (SCS) Versus Nerve Blocks and Physical Therapy for Complex Regional Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator decided to withdraw participation in the study
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complex Regional Pain Syndrome, Chronic Pain, Pain
    Keywords
    Pain, Neurostimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal Cord Stimulation (SCS) Group
    Arm Type
    Active Comparator
    Arm Description
    Spinal Cord Stimulation (SCS) Treatment Group
    Arm Title
    Nerve Blocks and PT
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Precision SCS
    Intervention Description
    Precision Spinal Cord Stimulation (SCS) Therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    Nerve Blocks and PT
    Intervention Description
    Pain therapy utilizing Nerve Blocks with Physical Therapy
    Primary Outcome Measure Information:
    Title
    The primary endpoint is reduction in baseline levels of pain;
    Time Frame
    12-weeks post SCS treatment compared to Nerve Blocks+PT

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Simopoulos, MD
    Organizational Affiliation
    Beth Israel Deaconess Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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