OsteoarthritisNCT00059345
Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis
A study testing Acupuncture in people with Osteoarthritis, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 639 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Impact of Patient-Provider Interaction on Response to Acupuncture
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis
- Being tested
- Acupuncture, Placebo acupuncture, Usual Care
- Keywords
- Acupuncture, Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Electroacupuncture, TENS
Electroacupuncture treatments provided two times per week for 6 weeks
Placebo acupunctureProcedure or surgery
Also called Sham acupuncture
Placebo acupuncture treatments provided 2 times per week for 6 weeks
Usual CareOther
Usual care for knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Acupuncture | Experimental | Participants will receive acupuncture Receives: Procedure: Acupuncture |
| Arm 2: Shallow needling | Placebo comparator | Participants will receive shallow needling on non-mederian points Receives: Procedure: Placebo acupuncture |
| Arm 3: No Acupuncture or Placebo Treatment | Other | Participants will receive usual care, no acupuncture or placebo acupuncture treatment. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
Measured: 3-month
Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain
Measured: 3-month
Patient satisfaction with their knee condition (SKIP)
Measured: 3-month
Secondary outcomes (11)
SF-12
Measured: 3-month
Range of motion of each knee
Measured: 3-month
Timed walking test
Measured: 3-month
Locus of control
Measured: Baseline
Optimism
Measured: 3-month
Self-efficacy
Measured: baseline
Cognitive pain
Measured: 3-month
Anxiety
Measured: 3-month
Social support
Measured: 3-month
Patient reaction
Measured: 3-month
Physician trust
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2003 (estimated)
- Study startSep 2002
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Maria E. Suarez-Almazor, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059345
- Sponsor's protocol ID
- R01AR049999
- Other IDs
- R01AR049999, NIAMS-087, 2006-0605
- Status last verified
- Nov 2013
- First submitted
- 23 Apr 2003
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20506122Street 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.
PubMed 22857778
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient-Provider Interaction on Response to Acupuncture
- ClinicalTrials.gov ID
- NCT00059345
- Acronym / sponsor ID
- R01AR049999
- Conditions
- Osteoarthritis
- Keywords
- Acupuncture, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 24 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Acupuncture | Experimental | Procedure: AcupunctureParticipants will receive acupuncture |
| Arm 2: Shallow needling | Placebo comparator | Procedure: Placebo acupunctureParticipants will receive shallow needling on non-mederian points |
| Arm 3: No Acupuncture or Placebo Treatment | Other | Other: Usual CareParticipants will receive usual care, no acupuncture or placebo acupuncture treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Electroacupuncture, TENSElectroacupuncture treatments provided two times per week for 6 weeks | Procedure or surgery | Arm 1: Acupuncture |
| Placebo acupunctureAlso: Sham acupuncturePlacebo acupuncture treatments provided 2 times per week for 6 weeks | Procedure or surgery | Arm 2: Shallow needling |
| Usual CareUsual care for knee osteoarthritis | Other | Arm 3: No Acupuncture or Placebo Treatment |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
Time frame: 3-month
Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain
Time frame: 3-month
Patient satisfaction with their knee condition (SKIP)
Time frame: 3-month
11 secondary outcomes
SF-12
Time frame: 3-month
Range of motion of each knee
Time frame: 3-month
Timed walking test
Time frame: 3-month
Locus of control
Time frame: Baseline
Optimism
Time frame: 3-month
Self-efficacy
Time frame: baseline
Cognitive pain
Time frame: 3-month
Anxiety
Time frame: 3-month
Social support
Time frame: 3-month
Patient reaction
Time frame: 3-month
Physician trust
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Results publication: PubMed 20506122Suarez-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.
- Derived from this study: PubMed 22857778Street 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.
- University of Texas (UT) MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria E. Suarez-Almazor, MD, PhD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Osteoarthritis, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (time frame: 3-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.