NCT00104156

Brief Summary

The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis (OA). Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater symptom improvement than sham treatment. 2) Individuals with a history of complementary and alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy than those without such experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

2.6 years

First QC Date

February 23, 2005

Last Update Submit

January 23, 2008

Conditions

Osteoarthritis

Keywords

Knee painArthritisQigongQiMeditationBreathing Exercises

Outcome Measures

Primary Outcomes (1)

  • Pain, stiffness, and physical function scale results

Secondary Outcomes (5)

  • McGill Pain Questionnaire (MPQ-SF) results

  • Spielberger State-Trait Anxiety Scale (STAI) results

  • Daily dosage of drugs for pain relief

  • Range of motion for knees

  • Time to walk 50 feet

Interventions

External Qigong therapyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of osteoarthritis at least 6 months prior to study entry
  • Able to understand English

You may not qualify if:

  • Inflammatory joint disease affecting leg movement
  • Knee replacement surgery on the OA knee
  • Depo-corticosteroid knee injections within 3 months prior to study entry
  • Pain in hips or lower back affecting leg movement
  • New arthritis drugs or other painkillers within 2 weeks prior to study entry
  • Investigational drugs within 30 days prior to study entry
  • Asthma requiring oral corticosteroids within 4 weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Newark, New Jersey, 07103, United States

Location

University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kevin W. Chen, PhD MPH

    Division of Addiction Psychiatry, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

  • Leonard Sigal, MD

    Rheumatology Department - Biomedical Sciences Program, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 23, 2005

First Posted

February 24, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(2)