Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00487331
First received: June 15, 2007
Last updated: October 21, 2013
Last verified: October 2013
  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 ]

Enrollment: 52
Study Start Date: June 2007
Primary Completion Date: October 2013 (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:

  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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 21, 2013
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 September 11, 2014