Feasibility and Safety of Acupuncture for Systemic Lupus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493753
• Other study ID #: CRCD-ACU-SLE
• Status: Completed
• Phase: N/A
• First received: June 26, 2007
• Last updated: June 26, 2007
• Start date: November 2004
• Est. completion date: April 2006

Study information

• Verified date: June 2007
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
United States	UPMC General Clinical Research Center	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Center for Integrative Medicine	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)		6 weeks
Secondary	pre-post treatment effect size estimates for self-reported pain and fatigue		6 weeks