Acupuncture in Spinal Cord Injury Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Spinal Cord Injuries
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Objective/Hypothesis: Our overarching hypothesis is that acupuncture is beneficial following acute traumatic SCI with respect to severity of neuropathic pain syndromes, patient-perceived quality of life measures, and functional outcomes. The current literature suggests that acupuncture may improve u...
Objective/Hypothesis: Our overarching hypothesis is that acupuncture is beneficial following acute traumatic SCI with respect to severity of neuropathic pain syndromes, patient-perceived quality of life measures, and functional outcomes. The current literature suggests that acupuncture may improve upon traditional pharmacological treatment results for SCI related pain, and that patients are seeking improved pain management in order to improve their quality of life. While data is limited, there may also be improvement in motor functional recovery with the use of acupuncture. We do know that SCI related pain limits patient participation in rehabilitation, thus advances in the management of SCI related pain is a priority in SCI research in order to improve outcomes after SCI. Specific Aims: Specific Aim 1: To determine whether patients treated with acupuncture started during acute care have better immediate and long-term pain scores and decreases in self-reported pain interference. Specific Aim 2: To determine whether patients treated with acupuncture started during acute care will have better overall quality of life measurements and improvements in self-reported well-being and resilience. Specific Aim 3: To determine whether patients treated with acupuncture started during acute care will have improvement in functional recovery in comparison to the control group. Study Design: This trial will compare pain scores and patient-perceived quality of life for individuals who receive early and regular acupuncture therapy to a control group. Patients with blunt or penetrating traumatic SCI will be included. The Investigators will enroll 100 subjects over a 36-month period from the R Adams Cowley Shock Trauma Center (STC). Once consent is obtained, enrolled patients will be evaluated using the ISNCSCI examination. Information about neuropathic pain and quality of life will be scored using NIH CDE recommended validated instruments within 72 hours of injury, during the 8-week treatment period, and at 3 and 6 months. The primary outcome is the improvement in NRS. The secondary outcomes are improvements in quality of life and functional recovery. Statistical analyses will involve constructive repeated measures mixed models to estimate the effect of treatment. Clinical Impact: The proposed trial will investigate the promising intervention of acupuncture for the management of neuropathic pain related to SCI. Improvement in neuropathic pain management is crucial in improving patients' rehabilitation, quality of life and ultimate outcome.
Tracking Information
- NCT #
- NCT03197675
- Collaborators
- United States Department of Defense
- Investigators
- Principal Investigator: Deborah Stein, MD, MPH Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center