NCT00070824

Brief Summary

The goal of this study is to use single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (f-MRI) of the brain to study the response of both normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2004

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2007

First QC Date

October 8, 2003

Last Update Submit

September 6, 2007

Conditions

Osteoarthritis

Keywords

AcupunctureSPECTf-MRIFunctional brain imagingRCT

Outcome Measures

Primary Outcomes (1)

  • SPECT Cerebral Bloodflow

    24 hours

Secondary Outcomes (1)

  • 0-10 Numeric Rating Scale for Pain Intensity

    1 hour

Study Arms (2)

B

EXPERIMENTAL

Patients with osteoarthritis pain at rest

Procedure: acupuncture

A

EXPERIMENTAL

Normal Subjects without pain

Procedure: acupuncture

Interventions

acupuncturePROCEDURE
AB

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seen in an outpatient clinical setting
  • Have active knee OA of \>6 months including Kellgren x-ray changes \>2 from an x-ray report \<12 months old or new x-ray interpretation
  • Moderate unilateral only pain (average \>4/10 on a 0-10 likert scale) for more than 5 out of 7 days
  • Have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer

You may not qualify if:

  • Having had acupuncture before (must be acupuncture naïve)
  • Any history of claustrophobia that could affect the subject's ability to tolerate the f-MRI study
  • Hip or ankle disease by history or exam severe enough to cause pain \>2/10 daily
  • Bleeding disorder or current use of warfarin or heparin by patient history
  • Other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • John T. Farrar, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 8, 2003

First Posted

October 13, 2003

Study Start

January 1, 2004

Study Completion

April 1, 2007

Last Updated

September 10, 2007

Record last verified: 2007-09

Locations

US(1)