Efficacy of Acupuncture With Physical Therapy for Knee Osteo-Arthritis

NCT00035399 | Completed Phase 3 DMC

• 1 other identifier: R01AT000304-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This study will examine the efficacy of acupuncture in combination with exercise physical therapy for moderate osteoarthritis (OA) of the knee.

Conditions

Osteoarthritis

Keywords

acupressure /acupuncture; alternative medicine; arthritis therapy; combination therapy; human therapy evaluation; knee; osteoarthritis; physical therapy; chronic pain; clinical trial; functional ability

Interventions

Acupuncture PROCEDURE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• X-ray proven osteoarthritis of the knee - Kellgren level 2 or greater
• More than 3 months of moderate knee pain
• Previous trial of NSAIDs or acetaminophen
• Physician referral for at least 6 physical therapy treatments
• Capacity to understand the requirements of the study and complete questionnaires
• Average knee pain with movement, 4 or above, during the last week

You may not qualify if:

• Average hip, back, ankle pain is greater than average knee pain (scale 1-10)
• Back, hip or ankle pain substantially interferes with patient knee assessment
• History of gout
• Acupuncture in the last year
• Moderate or greater hip or ankle pain greater than 3 daily
• Local corticosteroid injection into the effected knee within the past 4 weeks
• Hyaluronidase within the past 6 months
• Bleeding disorder or current use of Coumadin or Heparin
• Cardiac or pulmonary disease limiting exercise tolerance enough to limit the standard exercise physical therapy
• History of alcohol or drug abuse within the past 6 months
• Unable to complete a six minute walk test

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (3)

Penn Therapy and Fitness

Philadelphia, Pennsylvania, 19104, United States

Location

Veterans Administration Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital Sports Medicine/Rehabilitation Center

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• John T. Farrar, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: March 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

US (3)