Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study
Completed · Phase 1/Phase 2
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT00432289
- Run by
- Craig Hospital
- People needed
- 30
- Starts
- 2006-11-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2010-06-11
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Craig Hospital — Englewood, Colorado, United States
Full record on ClinicalTrials.gov
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