Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study - NCT00432289-80113 (Clinical Trial 162115)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy162115.aspx
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| City: |
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Englewood |
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State:
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CO |
| Zip Code: |
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80113 |
| Conditions: |
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Spinal Cord Injury |
| Purpose: |
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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 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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| Study summary: |
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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. |
| Criteria: |
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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:
1. Incomplete spinal cord injury - ASIA grade B or C.
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:
1. Current involvement in any other clinical research trial
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. |
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| Study is available at: |
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Craig Hospital
Englewood, CO 80113
United States
Primary Contact:
Amit Jha, MD
Email: ajha@craighospital.org
Phone: 303-789-8564 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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