Feasibility and Safety of Acupuncture for Systemic Lupus

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00493753
First received: June 26, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00493753     History of Changes
Other Study ID Numbers: CRCD-ACU-SLE
Study First Received: June 26, 2007
Last Updated: June 26, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014