Status:
COMPLETED
Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study
Lead Sponsor:
Craig Hospital
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. ...
Detailed Description
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 wil...
Eligibility Criteria
Inclusion
- 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:
- Incomplete spinal cord injury - ASIA grade B or C.
- Age 16 years or older.
- Must be admitted to Craig and enrolled in the study within 6 weeks of injury.
- Patient must be able to tolerate lying on side for 30 minutes.
- The expected length of stay will allow completion of the six-week study protocol.
- Must agree to forego any acupuncture treatment other than the treatments prescribed in this protocol during the six week study period.
Exclusion
- Current involvement in any other clinical research trial
- Concomitant treatment with anticoagulation medication (does not include those on prophylactic doses for deep venous thrombosis)
- Any disease, concomitant injury, condition or treatment that interferes with the performance or interpretation of the neurological examinations.
- Acupuncture sites obstructed by immobilization devices, where removal would be medically contraindicated.
- Individuals with cardiac pacemakers.
- Individual has a condition that, in the judgment of the investigator, precludes successful participation in the study.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00432289
Start Date
November 1 2006
End Date
June 1 2009
Last Update
June 11 2010
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113