Spinal Cord Stimulation Versus Nerve Blocks and Physical Therapy

NCT00414804 | Withdrawn

• 1 other identifier: SCS0805
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complex Regional Pain Syndrome; Chronic Pain; Pain

Keywords

Pain; Neurostimulation

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is reduction in baseline levels of pain;

  12-weeks post SCS treatment compared to Nerve Blocks+PT

Study Arms (2)

Spinal Cord Stimulation (SCS) Group

ACTIVE COMPARATOR

Spinal Cord Stimulation (SCS) Treatment Group

Device: Precision SCS

Nerve Blocks and PT

ACTIVE COMPARATOR

Procedure: Nerve Blocks and PT

Interventions

Precision SCS DEVICE

Precision Spinal Cord Stimulation (SCS) Therapy

Spinal Cord Stimulation (SCS) Group

Nerve Blocks and PT PROCEDURE

Pain therapy utilizing Nerve Blocks with Physical Therapy

Nerve Blocks and PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Chronic Pain; Pain

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Thomas Simopoulos, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 22, 2006
• Study Start: December 1, 2006
• Last Updated: February 15, 2012

Record last verified: 2012-02