ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487331
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Pain Other: Acupuncture Behavioral: Survey Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
Study Start Date : June 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Patients' Reported Satisfaction with Acupuncture Services [ Time Frame: Derived from surveys completed by participating patients over 3 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.)
  6. Planned changes in the pain medication regimen.
  7. Women who are pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00487331     History of Changes
Other Study ID Numbers: 2006-1113
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: October 2013

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Acupuncture
Uncontrolled Pain
Pain