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Sponsored by: |
Craig Hospital |
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Information provided by: | Craig Hospital |
ClinicalTrials.gov Identifier: | NCT00432289 |
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before conducting a larger, more definitive study, this exploratory and developmental work is focused on assessing whether blinding is possible, reproducibility of the outcome measure, determine enrollment rates and effect sizes and identify clinical resources needed to conduct a larger study.
Condition | Intervention | Phase |
---|---|---|
Spinal Cord Injury |
Procedure: Acupuncture |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Acupuncture for Treatment of Acute Spinal Cord Injury |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
The research design for this exploratory/developmental R21 application will be the same as the anticipated design for a future definitive R01 investigation. A randomized controlled treatment study will be used to compare neurological recovery after spinal cord injury (SCI) in individuals receiving an acupuncture protocol designed to maximize treatment effectiveness (treatment protocol) with an alternative acupuncture protocol designed to minimize treatment effectiveness (control). The two acupuncture protocols will be identical except for 1) needle placement, 2) use of sham, non-penetrating needles and 3) use of electricity for needle stimulation. The two protocols are designed to be indistinguishable to an individual, so participants will remain blind to whether they are receiving the treatment or the control protocol.
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before proposing a definitive R01 investigation to test this hypothesis, several preliminary steps are required and will be addressed in this feasibility study. Five objectives have been identified for the current R21 application as follows.
Objective 1 - Demonstrate that participants are unable to distinguish between treatment and control protocols, assuring participant blinding.
Objective 2 - Verify the inter-rater reliability of the primary outcome measures —the American Spinal Injury Association (ASIA) motor and sensory scores as defined by the ASIA Standards for Neurological Classification of SCI.1
Objective 3 - Collect pilot data for use in power analysis to determine the desired sample size in the definitive R01 investigation, including effect sizes, enrollment and dropout rates.
Objective 4 - Identify any unanticipated difficulties in implementing the treatment and control protocols and identify the clinical resources needed to conduct an R01 investigation.
Objective 5 - Prepare an application for an R01 definitive investigation including an operations manual for the protocol.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Individuals admitted to Craig Hospital immediately following initial acute care hospitalization with a primary diagnosis of acute SCI will be considered for study inclusion. Participants must give their informed consent, have medical clearance from their attending physician and meet the following inclusion criteria:
Exclusion Criteria:
Contact: Amit Jha, MD | 303-789-8564 | ajha@craighospital.org |
United States, Colorado | |
Craig Hospital | Recruiting |
Englewood, Colorado, United States, 80113 | |
Principal Investigator: Amit Jha, MD |
Principal Investigator: | Amit Jha, MD | Craig Hospital |
Responsible Party: | Craig Hospital ( Amit Jha, MD ) |
Study ID Numbers: | R21AT002763 |
Study First Received: | February 5, 2007 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00432289 History of Changes |
Health Authority: | United States: Institutional Review Board |
neurological function |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |