Feasibility and Safety of Acupuncture for Systemic Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493753
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : June 28, 2007
Information provided by:
University of Pittsburgh

Brief Summary:
The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Procedure: Acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus
Study Start Date : November 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Lupus

Primary Outcome Measures :
  1. Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. pre-post treatment effect size estimates for self-reported pain and fatigue [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent.

Exclusion Criteria:

  • known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets < 100,000, previous course of acupuncture treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493753

United States, Pennsylvania
UPMC General Clinical Research Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Carol M Greco, Ph.D. University of Pittsburgh Identifier: NCT00493753     History of Changes
Other Study ID Numbers: CRCD-ACU-SLE
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases