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treatment group for Spinal Cord Injury

N/A

Waitlist Available

Led By Deborah Stein, MD, MPH

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months following hospital discharge

Awards & highlights

Study Summary

This trial will test the effectiveness of acupuncture for treating pain in veterans with spinal cord injury.

Eligible Conditions

Spinal Cord Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months following hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months following hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months following hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Pain

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: treatment groupActive Control1 Intervention

Participants within the acupuncture treatment group will receive traditional body acupuncture with electrical stimulation for 30 minutes three times a week, additionally participants will also receive auricular acupuncture once a week with the needles retained in both ears for seven days and replaced the following week, for a total of eight weeks (24 treatments of conventional acupuncture, 8 treatments of auricular acupuncture). Pain Numeric Rating Score (NRS) will be evaluated by the research staff before and after each treatment. All participants will then be reevaluated with the described assessment tools at three months and again at six months. Acupuncturists will not participate in the three and six month evaluations of subjects.

Group II: Control groupPlacebo Group1 Intervention

Participants who are randomized to the control group will not receive any acupuncture. Participants will however be assessed weekly to obtain the same data on their pain scale and other outcome measures as the treatment group. Participants will be evaluated in person during their standard of care clinical follow up appointments at the three month and six month points for in person interviews and data collection .

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Who is running the clinical trial?

United States Department of DefenseFED

861 Previous Clinical Trials

227,125 Total Patients Enrolled

University of Maryland, BaltimoreLead Sponsor

687 Previous Clinical Trials

374,577 Total Patients Enrolled

Deborah Stein, MD, MPHPrincipal Investigator - Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center

Medical School - Albert Einstein College of Medicine of Yeshiva University

2 Previous Clinical Trials

354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this experiment?

"This clinical trial is recruiting 100 patients with spinal cord injuries aged between 18 and 75. To qualify, candidates must have suffered a blunt or penetrating trauma to their cervical, thoracic or lumbar spine resulting in an AIS A-D classification of injury severity."

Answered by AI

Is there an age cutoff for eligibility in this research trial?

"This trial requires potential participants to be within the ages of 18-75. For those under 18, there are 138 relevant studies and for individuals older than 65 an additional 732 trials exist."

Answered by AI

How many individuals are taking part in this clinical research endeavor?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this medical trial has resumed participant recruitment; it was originally posted on March 14th 2018 and has recently been updated on May 4th 2022. The study is currently seeking 100 patients from a single site."

Answered by AI

Are recruitment efforts underway to involve participants in this experiment?

"Information on clinicaltrials.gov states that this medical trial is actively recruiting, with the initial posting occurring on March 14th 2018 and the most recent update taking place in May 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acupuncture in Spinal Cord Injury Subjects

Deborah Stein 2018. "Acupuncture in Spinal Cord Injury Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03197675.