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

NCT00432289 | Completed Phase 1 DMC

• 1 other identifier: R21AT002763
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Spinal Cord Injury

Keywords

neurological function

Outcome Measures

Primary Outcomes (1)

• ASIA Standards for Neurological Classification of SCI

  Baseline and 6 weeks post treatment

Interventions

Acupuncture PROCEDURE

Acupunture treatment 3x per week for 6 weeks.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Amit Jha, MD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 7, 2007
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)