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Completed

NCT Number: NCT00059345

Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine, Houston, Texas, United States

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About this study

This study will examine placebo responses in the context of practitioner-patient interactions at the time of the encounter. Phase 1 of this study identified patient-related determinants of placebo response, such as beliefs and expectations toward treatment of knee OA with acupuncture. Phase 2 of the study evaluated an assessment tool to measure these determinants. Phase 3 of the study is a randomized controlled trial to evaluate whether placebo effects in patients with knee OA can be enhanced by the acupuncturists' communicative style, which can affect a patient's cognitive expectancies and beliefs.

Patients will initially be randomized to one of two groups, each with a different model for practitioner-patient interaction. Acupuncture practitioners will be trained to follow semi-structured communicative styles, including traditional approaches in Chinese medicine and techniques previously described in patient-doctor communications studies. Within each of these groups, patients will be further randomized to receive either acupuncture or sham acupuncture. Patients will have 6 weeks of biweekly treatment visits. Patients will be followed for 6 months. Visits will be weekly during the first 6 weeks of the study and monthly thereafter.

The study will also include a natural cohort group composed of patients on a study waiting list; these patients will be offered acupuncture 3 months after study entry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Acupuncture

Procedure

Electroacupuncture treatments provided two times per week for 6 weeks

Other names: Electroacupuncture, TENS

Placebo acupuncture

Procedure

Placebo acupuncture treatments provided 2 times per week for 6 weeks

Other names: Sham acupuncture

Usual Care

Other

Usual care for knee osteoarthritis

Primary outcomes

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

    Time frame: 3-month

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

    Time frame: 3-month

  3. Patient satisfaction with their knee condition (SKIP)

    Time frame: 3-month

Secondary outcomes

  1. SF-12

    Time frame: 3-month

  2. Range of motion of each knee

    Time frame: 3-month

  3. Timed walking test

    Time frame: 3-month

  4. Locus of control

    Time frame: Baseline

  5. Optimism

    Time frame: 3-month

  6. Self-efficacy

    Time frame: baseline

  7. Cognitive pain

    Time frame: 3-month

  8. Anxiety

    Time frame: 3-month

  9. Social support

    Time frame: 3-month

  10. Patient reaction

    Time frame: 3-month

  11. Physician trust

    Time frame: 3-month

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

The Impact of Patient-Provider Interaction on Response to Acupuncture

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Apr 24, 2003
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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