Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487331
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2007-06-15
Brief Title:
Acupuncture for Treatment of Uncontrolled Pain A Feasibility Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Acupuncture for Treatment of Uncontrolled Pain A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Acupuncture involves the insertion of small solid sterile needles into specific points on the skin The needles are placed in areas that are intended to help relieve pain Electrical stimulation is often applied to the needles to improve the treatment effects The procedure is designed to be comfortable and relaxing
Acupuncture Sessions
If you are found to be eligible to take part in this study you will receive acupuncture sessions 1-3 times per week in the acupuncture clinic at M D Anderson The number of sessions will depend on the type and location of the pain you may be experiencing
For each session you will be placed in a comfortable position and the study doctoracupuncturist will find points on your body andor ears where the needles will be placed These points will be chosen based on the symptoms you are having at the time of treatment the location of the pain and the type of pain
Very thin solid sterile stainless steel needles will be used All of the needles are specially made for acupuncture The depth of the needle in the skin the number of needles and whether the needles are near or far from the areas of pain will vary from person to person based on standard acupuncture procedures
In most instances needles placed on body points will remain in place for about 20-30 minutes This length of time is the same for some points on the ears as well but in some instances small gold or stainless steel needles may be placed on the ears These needles for the ears are designed to remain in place for 3-4 days The ear needles are slightly larger than the head of a pin and have a small ridge that is designed to help them remain in place If you prefer a small flesh colored adhesive patch can be placed over the ear needles as added protection This is usually not necessary but can be added if you prefer
Electrical stimulation may be added to some of the needles depending on the type of pain you are experiencing and where it is located This involves placing wires on the needles which are connected to a machine that delivers a mild electrical current through the wires The intensity strength of the electrical current will be adjusted gradually until it is at a comfortable level for you
Study Procedures
At each session before you receive the acupuncture the following procedures will be performed
Your vital signs will be measured
You will be asked about any medications you may be taking and any side effects you may be experiencing
The color and coating of your tongue and the quality of your pulse will be recorded
If you are receiving medications that are known to affect your blood counts blood about 1 teaspoon will be drawn for routine tests to check your blood counts
Each study visit will last about 1 hour During the study you may still receive your regular pain treatments outside of this study
Length of Study Participation
You may receive up to 10 acupuncture sessions depending on the location and type of pain If intolerable side effects or symptoms occur you will be taken off study early
End-of-Study Visit
On the day of your last acupuncture session called the end-of-study visit or if you go off study early for any reason the following procedures will be performed
Your medical history will be recorded Your vital signs will be measured You will be asked about any medications you may be taking and any side effects you may have experienced
You will complete the same 2 pain questionnaires as before You will also complete a questionnaire that has questions about your level of satisfaction with the acupuncture services that were provided In total the 3 questionnaires should take about 15 minutes to complete
Your tongue and pulse will be evaluated
Study Completion
After the end-of-study visit your participation in this study will be over
This is an investigational study The needles used in this study are FDA approved for use in patients with cancer It is considered experimental however to provide acupuncture services to patients with cancer who have uncontrolled pain Up to 64 patients will take part in this study All will be enrolled at M D Anderson
Acupuncture Sessions
If you are found to be eligible to take part in this study you will receive acupuncture sessions 1-3 times per week in the acupuncture clinic at M D Anderson The number of sessions will depend on the type and location of the pain you may be experiencing
For each session you will be placed in a comfortable position and the study doctoracupuncturist will find points on your body andor ears where the needles will be placed These points will be chosen based on the symptoms you are having at the time of treatment the location of the pain and the type of pain
Very thin solid sterile stainless steel needles will be used All of the needles are specially made for acupuncture The depth of the needle in the skin the number of needles and whether the needles are near or far from the areas of pain will vary from person to person based on standard acupuncture procedures
In most instances needles placed on body points will remain in place for about 20-30 minutes This length of time is the same for some points on the ears as well but in some instances small gold or stainless steel needles may be placed on the ears These needles for the ears are designed to remain in place for 3-4 days The ear needles are slightly larger than the head of a pin and have a small ridge that is designed to help them remain in place If you prefer a small flesh colored adhesive patch can be placed over the ear needles as added protection This is usually not necessary but can be added if you prefer
Electrical stimulation may be added to some of the needles depending on the type of pain you are experiencing and where it is located This involves placing wires on the needles which are connected to a machine that delivers a mild electrical current through the wires The intensity strength of the electrical current will be adjusted gradually until it is at a comfortable level for you
Study Procedures
At each session before you receive the acupuncture the following procedures will be performed
Your vital signs will be measured
You will be asked about any medications you may be taking and any side effects you may be experiencing
The color and coating of your tongue and the quality of your pulse will be recorded
If you are receiving medications that are known to affect your blood counts blood about 1 teaspoon will be drawn for routine tests to check your blood counts
Each study visit will last about 1 hour During the study you may still receive your regular pain treatments outside of this study
Length of Study Participation
You may receive up to 10 acupuncture sessions depending on the location and type of pain If intolerable side effects or symptoms occur you will be taken off study early
End-of-Study Visit
On the day of your last acupuncture session called the end-of-study visit or if you go off study early for any reason the following procedures will be performed
Your medical history will be recorded Your vital signs will be measured You will be asked about any medications you may be taking and any side effects you may have experienced
You will complete the same 2 pain questionnaires as before You will also complete a questionnaire that has questions about your level of satisfaction with the acupuncture services that were provided In total the 3 questionnaires should take about 15 minutes to complete
Your tongue and pulse will be evaluated
Study Completion
After the end-of-study visit your participation in this study will be over
This is an investigational study The needles used in this study are FDA approved for use in patients with cancer It is considered experimental however to provide acupuncture services to patients with cancer who have uncontrolled pain Up to 64 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None