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Feasibility and Safety of Acupuncture for Systemic Lupus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493753
First Posted: June 28, 2007
Last Update Posted: June 28, 2007
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.
Information provided by:
University of Pittsburgh
  Purpose
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 Intervention
Systemic Lupus Erythematosus Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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

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

Enrollment: 24
Study Start Date: November 2004
Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00493753


Locations
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
Investigators
Principal Investigator: Carol M Greco, Ph.D. University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00493753     History of Changes
Other Study ID Numbers: CRCD-ACU-SLE
First Submitted: June 26, 2007
First Posted: June 28, 2007
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