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Withdrawn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
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring Pain, Neurostimulation
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.
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
NCT ID
NCT00414804
First Posted
December 20, 2006
Last Updated
February 13, 2012
Sponsor
Boston Scientific Corporation
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Withdrawn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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Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy
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