NCT00059345

Brief Summary

Interactions between patients and healthcare providers may have a significant impact on a patient's response to therapy. In this study, patients with osteoarthritis (OA) of the knee will receive either acupuncture or sham acupuncture. The acupuncturists will be trained to interact with the patients in specific ways. The study will evaluate those interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
639

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

Enrollment Period

3.8 years

First QC Date

April 23, 2003

Last Update Submit

November 15, 2013

Conditions

Osteoarthritis

Keywords

AcupunctureArthritis

Outcome Measures

Primary Outcomes (3)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale

    3-month

  • Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain

    3-month

  • Patient satisfaction with their knee condition (SKIP)

    3-month

Secondary Outcomes (11)

  • SF-12

    3-month

  • Range of motion of each knee

    3-month

  • Timed walking test

    3-month

  • Locus of control

    Baseline

  • Optimism

    3-month

  • +6 more secondary outcomes

Study Arms (3)

Arm 1: Acupuncture

EXPERIMENTAL

Participants will receive acupuncture

Procedure: Acupuncture

Arm 2: Shallow needling

PLACEBO COMPARATOR

Participants will receive shallow needling on non-mederian points

Procedure: Placebo acupuncture

Arm 3: No Acupuncture or Placebo Treatment

OTHER

Participants will receive usual care, no acupuncture or placebo acupuncture treatment.

Other: Usual Care

Interventions

AcupuncturePROCEDURE

Electroacupuncture treatments provided two times per week for 6 weeks

Also known as: Electroacupuncture, TENS
Arm 1: Acupuncture
Placebo acupuncturePROCEDURE

Placebo acupuncture treatments provided 2 times per week for 6 weeks

Also known as: Sham acupuncture
Arm 2: Shallow needling
Usual CareOTHER

Usual care for knee osteoarthritis

Arm 3: No Acupuncture or Placebo Treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA diagnosis according to the American College of Rheumatology criteria
  • Pain in the knee of at least 3 or more on a 0 to 10 scale (0 none, 10 extreme pain) within 2 weeks prior to study entry
  • Stable treatment with anti-inflammatory and analgesic medications during the month prior to study entry
  • If receiving glucosamine, stable dosage for 2 months prior to study entry
  • Adequate cognitive status as determined by the study officials
  • Living in the community
  • Ability to communicate in English without a translator
  • Access to a telephone

You may not qualify if:

  • Other diagnosed joint diseases, such as rheumatoid arthritis
  • Previous treatment with acupuncture (for any condition)
  • Intra-articular injections in the knee in the 2 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Suarez-Almazor ME, Looney C, Liu Y, Cox V, Pietz K, Marcus DM, Street RL Jr. A randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of patient-provider communication. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1229-36. doi: 10.1002/acr.20225.

    PMID: 20506122RESULT

  • Street RL Jr, Cox V, Kallen MA, Suarez-Almazor ME. Exploring communication pathways to better health: clinician communication of expectations for acupuncture effectiveness. Patient Educ Couns. 2012 Nov;89(2):245-51. doi: 10.1016/j.pec.2012.06.032. Epub 2012 Jul 31.

    PMID: 22857778DERIVED

Related Links

MeSH Terms

Conditions

OsteoarthritisArthritis

Interventions

Acupuncture TherapyElectroacupunctureTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Maria E. Suarez-Almazor, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2003

First Posted

April 24, 2003

Study Start

September 1, 2002

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations

US(2)