Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study

This study has been completed.
Sponsor:
Information provided by:
Craig Hospital
ClinicalTrials.gov Identifier:
NCT00432289
First received: February 5, 2007
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Acupuncture for Treatment of Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • ASIA Standards for Neurological Classification of SCI [ Time Frame: Baseline and 6 weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Acupuncture
    Acupunture treatment 3x per week for 6 weeks.
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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432289

Locations
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
Investigators
Principal Investigator: Amit Jha, MD Craig Hospital
  More Information

No publications provided

Responsible Party: Amit Jha, MD, Craig Hospital
ClinicalTrials.gov Identifier: NCT00432289     History of Changes
Other Study ID Numbers: R21AT002763
Study First Received: February 5, 2007
Last Updated: June 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
neurological function

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014