Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study

NCT00487331 | Completed

• 1 other identifier: 2006-1113
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Pain

Keywords

Solid Tumors; Acupuncture; Uncontrolled Pain; Pain

Outcome Measures

Primary Outcomes (1)

• Patients' Reported Satisfaction with Acupuncture Services

  Derived from surveys completed by participating patients over 3 Years

Study Arms (1)

Acupuncture

EXPERIMENTAL

Acupuncture sessions 1-3 times per week. 2 pain questionnaires + satisfaction survey completed at beginning and end of treatment.

Other: Acupuncture; Behavioral: Survey

Interventions

Acupuncture OTHER

Acupuncture sessions 1-3 times per week.

Acupuncture

Survey BEHAVIORAL

2 pain questionnaires + satisfaction survey completed at beginning and end of treatment

Also known as: questionnaire

Acupuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Larry C. Driver, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 9, 2015

Record last verified: 2013-10

Locations

US (1)