Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study
NCT ID: NCT00432289
Last Updated: 2010-06-11
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2006-11-30
2009-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Acupuncture
Acupunture treatment 3x per week for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Age 16 years or older.
3. Must be admitted to Craig and enrolled in the study within 6 weeks of injury.
4. Patient must be able to tolerate lying on side for 30 minutes.
5. The expected length of stay will allow completion of the six-week study protocol.
6. Must agree to forego any acupuncture treatment other than the treatments prescribed in this protocol during the six week study period.
Exclusion Criteria
2. Concomitant treatment with anticoagulation medication (does not include those on prophylactic doses for deep venous thrombosis)
3. Any disease, concomitant injury, condition or treatment that interferes with the performance or interpretation of the neurological examinations.
4. Acupuncture sites obstructed by immobilization devices, where removal would be medically contraindicated.
5. Individuals with cardiac pacemakers.
6. Individual has a condition that, in the judgment of the investigator, precludes successful participation in the study.
16 Years
ALL
No
Sponsors
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Craig Hospital
OTHER
Responsible Party
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Craig Hospital
Principal Investigators
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Amit Jha, MD
Role: PRINCIPAL_INVESTIGATOR
Craig Hospital
Locations
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Craig Hospital
Englewood, Colorado, United States
Countries
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Other Identifiers
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