CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Acupunctureprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01376375
NCT01376375Phase 1Completed

A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain

National Center for Complementary and Integrative Health (NCCIH)·interventional·Posted Jun 20, 2011·Updated Dec 17, 2019

In Brief

A Phase 1 clinical trial evaluating Acupuncture for Pain. Completed, enrolled 5 participants across 1 site.

Detailed Summary

Background: \- Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Researchers will look at blood samples for changes in different chemicals related to inflammation and pain. Objectives: \- To test the effect of acupuncture on blood chemicals associated with chronic low back pain. Eligibility: * People at least 18 years of age who have chronic low back pain. * Those who have had back surgery or had acupuncture for any medical condition may not participate. Design: * This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours. * At the first study visit, participants will give a medical history and complete two questionnaires about their low back pain. They will also spend 30 minutes lying down on a bed, relaxing quietly. * The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic the standard procedure, but no needles will be used. The standard procedure will be performed in the same location. A licensed, experienced acupuncturist will insert small disposable needles into acupuncture sites on the back, arms, and legs. Those in the study will not know whether they are receiving the sham or the standard acupuncture procedure. * At some visits, participants will provide blood samples for testing. At every visit, participants will complete the questionnaires about low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2011
Enrollment StartJun 10, 2011
Primary CompletionApr 26, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.0 years ago

Interventions

Acupunctureprocedure