NCT00417313

Brief Summary

The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
Last Updated

January 1, 2007

Status Verified

December 1, 2006

First QC Date

December 28, 2006

Last Update Submit

December 28, 2006

Conditions

Osteoarthritis

Keywords

knee painacupuncture /acupressurealternative medicineanalgesiaarthritis therapychronic painfunctional ability

Outcome Measures

Primary Outcomes (1)

  • changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index

Secondary Outcomes (3)

  • changes in physical performance

  • psychosocial function (mood, self-efficacy, coping, fear, self-rated health)

  • sleep and appetite

Interventions

periosteal electro-acupuncture (osteopuncture).DEVICE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Radiographic evidence of knee OA on a standing AP X-ray
  • Bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day

You may not qualify if:

  • Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
  • Folstein Mini-Mental State Examination score of less than 24
  • Severe visual or hearing impairment
  • Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer
  • Significant pain in parts of the body other than the knee or acute knee pain
  • A large knee effusion or severe mechanical instability of the knee
  • History of corticosteroid injection in the affected knee(s) during the preceding 3 months
  • History of hyaluronic acid injection in the affected knee(s) during the preceding 3 months
  • Acute or terminal illness
  • Immune suppression
  • Anticoagulation therapy
  • Presence of a pacemaker
  • Prior acupuncture treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Evaluattion and Treatment Institute, Research Department

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

OsteoarthritisAgnosiaChronic Pain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Study Officials

  • Debra K Weiner, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

October 1, 2004

Study Completion

August 1, 2006

Last Updated

January 1, 2007

Record last verified: 2006-12

Locations

US(1)