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Completed

NCT Number: NCT00493753

Feasibility and Safety of Acupuncture for Systemic Lupus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC General Clinical Research Center, Pittsburgh, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Primary outcomes

  1. Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)

    Time frame: 6 weeks

Secondary outcomes

  1. pre-post treatment effect size estimates for self-reported pain and fatigue

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus

Important dates

Study start
2004
Study completion
2006
First posted
Jun 28, 2007
Registry last updated
Jun 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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