Pain ManagementEarly Phase 1NCT01059487
Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine
A Early Phase 1 study testing Traditional Chinese Medicine in people with Pain Management and Traditional Chinese Medicine, run by Chicago College of Oriental Medicine at 1 site in United States.
Trial summary
At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Traditional Chinese Medicine
- What is being tested?
- Traditional Chinese Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 21 and over
Who cannot join
- Children
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago College of Oriental Medicine, Inc. dba Chicago College of Asian Medicine
Chicago, Illinois, 60656
About this study
Official title: Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine: A Pragmatic Clinical Trial Using Quality of Life Measures in a Community Health Care Setting
At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment. The World Health Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With the completion of this pragmatic clinical trial and introduction of the Constant Care method of health care delivery to underserved communities on Chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future.
- Conditions
- Pain Management, Traditional Chinese Medicine
- Being tested
- Traditional Chinese Medicine
- Keywords
- Traditional Chinese Medicine, Acupuncture
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineOther
Also called Acupuncture, Tuina, Herbs, Moxabustion
Traditional Chinese Medicine includes acupuncture, herbal, tuina and other accessory techniques
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Other | Assessing efficacy of treating subjects/patients with Traditional Chinese Medicine (TCM) by administering SF-36v2 and PIQ-6 surveys to subjects/patients to create a baseline and then re-assessing quality of life achieved through TCM treatments by administering follow-up SF-12v2 and PIQ-6 surveys every four weeks Receives: Other: Traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QualityMetric SF36v-2 Quality of Life
Measured: Every four weeks
Secondary outcomes (1)
QualityMetric PIQ-6
Measured: Every four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Chicago College of Oriental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), QualityMetrics, Inspire Tech Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059487
- Sponsor's protocol ID
- HS-10-003 CEG
- Other IDs
- GRANT10504752
- Status last verified
- Jan 2010
- First submitted
- 29 Jan 2010
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine: A Pragmatic Clinical Trial Using Quality of Life Measures in a Community Health Care Setting
- ClinicalTrials.gov ID
- NCT01059487
- Acronym / sponsor ID
- HS-10-003 CEG
- Conditions
- Pain Management, Traditional Chinese Medicine
- Keywords
- Traditional Chinese Medicine, Acupuncture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Chicago College of Oriental MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), QualityMetrics, Inspire Tech Group
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 1 Feb 2010 (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.
At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment. The World Health Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With the completion of this pragmatic clinical trial and introduction of the Constant Care method of health care delivery to underserved communities on Chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Other | Other: Traditional Chinese MedicineAssessing efficacy of treating subjects/patients with Traditional Chinese Medicine (TCM) by administering SF-36v2 and PIQ-6 surveys to subjects/patients to create a baseline and then re-assessing quality of life achieved through TCM treatments by administering follow-up SF-12v2 and PIQ-6 surveys every four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults age 21 and over
Key exclusion criteria (2 listed)
- Children
- Pregnant women
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 |
|---|---|---|
| Traditional Chinese MedicineAlso: Acupuncture, Tuina, Herbs, MoxabustionTraditional Chinese Medicine includes acupuncture, herbal, tuina and other accessory techniques | Other | Traditional Chinese Medicine |
Primary outcome
QualityMetric SF36v-2 Quality of Life
Time frame: Every four weeks
1 secondary outcome
QualityMetric PIQ-6
Time frame: Every four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Traditional Chinese Medicine in people with Pain Management and Traditional Chinese Medicine, run by Chicago College of Oriental Medicine at 1 site 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeannette Hoyt (7087173568, j@chgocom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QualityMetric SF36v-2 Quality of Life (time frame: Every four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2010.