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Study Summary
No. 2006-1113:.......Pain......Larry C. Driver......Anesthesiology
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Study Summary Title
Study Summary
Number:
2006-1113
Study Title:Acupuncture for treatment of uncontrolled pain: a feasibility study
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Physician New Patient Referral
Name:Larry C. DriverPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:AnesthesiologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-7246
Contact us about clinical trials
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General Information
Disease Group:PainSupported By:N/A
Phase of Study:N/AReturn
Visit:
1-2 times per week for a maximum of 10 visits.
Treatment
Agents:
AcupunctureHome Care:n/a
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to learn if using acupuncture with
or without electrical stimulation in cancer patients with high levels of pain
can help to relieve the pain.
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Study Objectives / Outcomes
1.1 Primary Objective(s):

a. To evaluate the feasibility of providing acupuncture services to patients from the Pain Management Center (PMC) at M. D. Anderson Cancer Center (MDACC).

1.2 Secondary Objective(s):

a. To determine if acupuncture is effective in reducing pain among cancer patients from the PMC at MDACC.
b. To evaluate patient-reported satisfaction with the acupuncture services provided.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:06/13/2007
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients, or the legal guardians of patients must have the ability to understand English, sign a written informed consent, and be willing to follow protocol requirements.

2) ECOG Performance Status of 0, 1, or 2.

3) Pain score >/= 4 on the on a 0-10 NRS pain scale after all efforts have been attempted in the PMC to control pain.

Exclusion Criteria:1) Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)

2) Deformities that could interfere with accurate acupuncture point location.

3) Known coagulopathy and taking any dose of warfarin (i.e., Coumadin) or heparin, including low molecular weight heparin (i.e., Lovenox). Patients may participate if they are taking Plavix, aspirin or other non-steroidal anti-inflammatory agents.

4) Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry as these patients may not be able to cooperative with this slightly invasive procedure or with the data collection process.

5) Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not labwork is drawn prior to beginning the acupuncture treatment will be left to the discretion of the referring physician. Patients with platelets <100,000 may participate with written approval from the attending physician.)

6) Planned changes in the pain medication regimen.

7) Women who are pregnant.

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Links
Registration Number: NCT00487331
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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