Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00487331
First received: June 15, 2007
Last updated: October 19, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Solid Tumors Pain |
Other: Acupuncture Behavioral: Survey |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Patients' Reported Satisfaction with Acupuncture Services [ Time Frame: Derived from surveys completed by participating patients over 3 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acupuncture
Acupuncture sessions 1-3 times per week. 2 pain questionnaires + satisfaction survey completed at beginning and end of treatment.
|
Other: Acupuncture
Acupuncture sessions 1-3 times per week.
Behavioral: Survey
2 pain questionnaires + satisfaction survey completed at beginning and end of treatment
Other Name: questionnaire
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- ECOG Performance Status of 0, 1, or 2.
- 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:
- 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.)
- Deformities that could interfere with accurate acupuncture point location.
- 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.
- 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.
- Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not lab work 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.)
- Planned changes in the pain medication regimen.
- Women who are pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487331
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Larry C. Driver, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00487331 History of Changes |
| Other Study ID Numbers: | 2006-1113 |
| Study First Received: | June 15, 2007 |
| Last Updated: | October 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Solid Tumors Acupuncture Uncontrolled Pain Pain |
ClinicalTrials.gov processed this record on May 21, 2013