Spinal Cord Stimulation Efficacy Measures
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2006 |
| End Date: | August 2006 |
| Contact: | Chandra M Singh, B.S. |
| Email: | csingh320@gmail.com |
| Phone: | (718) 240-8177 |
The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
The purpose of the study is to measure the efficacy of varying spinal cord stimulation
frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator
settings that are most effective in chronic pain management hope to be revealed for the
purposes of this study. In this double-blind study, both the patient and the staff will not
be aware of the spinal cord stimulator settings for each patient each week. The
representative that will set the settings each week will be blinded to the identity of each
patient and will set the spinal cord stimulator from another room. While there are few
papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has
yet to be a study performed that measures the role of stimulation frequency and
pulse-widths. This study hopes to be the first.
frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator
settings that are most effective in chronic pain management hope to be revealed for the
purposes of this study. In this double-blind study, both the patient and the staff will not
be aware of the spinal cord stimulator settings for each patient each week. The
representative that will set the settings each week will be blinded to the identity of each
patient and will set the spinal cord stimulator from another room. While there are few
papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has
yet to be a study performed that measures the role of stimulation frequency and
pulse-widths. This study hopes to be the first.
For a total of 9 weeks, patients will be randomized to 9 stimulation frequency and
pulse-width setting combinations. The patient will stay with these settings for a week at a
time. Prior to the patient's first office visit, he/she will be asked to take a chest x-ray.
The patient will also repeat this chest x-ray at the end of the study. Each patient will be
asked to provide daily information regarding pain medication usage, spinal cord stimulation
usage, amplitude settings, and pain ratings. Additionally, patients will fill out the
Multidimensional Pain Inventory (MPI) and the McGill Pain Questionnaire (MPQ) every Monday
when they come to the office, before he/she is randomized to the new settings for the week.
The patient will also receive a call from the research assistant to see how he/she is doing
that week and the patient will be provided with all the pertinent contact information to
call at any time to ask questions. The patient can withdraw from the study completely at any
point or drop out of the settings for the week. The patient will have a follow-up visit a
month from the study's end date to discuss how the patient has been managing his/her pain at
his/her spinal cord stimulator settings. Each patient will be compensated for completing the
study. Efficacy will be measured based on the patient's answers to the pain probes, device
usage, and medication usage.
pulse-width setting combinations. The patient will stay with these settings for a week at a
time. Prior to the patient's first office visit, he/she will be asked to take a chest x-ray.
The patient will also repeat this chest x-ray at the end of the study. Each patient will be
asked to provide daily information regarding pain medication usage, spinal cord stimulation
usage, amplitude settings, and pain ratings. Additionally, patients will fill out the
Multidimensional Pain Inventory (MPI) and the McGill Pain Questionnaire (MPQ) every Monday
when they come to the office, before he/she is randomized to the new settings for the week.
The patient will also receive a call from the research assistant to see how he/she is doing
that week and the patient will be provided with all the pertinent contact information to
call at any time to ask questions. The patient can withdraw from the study completely at any
point or drop out of the settings for the week. The patient will have a follow-up visit a
month from the study's end date to discuss how the patient has been managing his/her pain at
his/her spinal cord stimulator settings. Each patient will be compensated for completing the
study. Efficacy will be measured based on the patient's answers to the pain probes, device
usage, and medication usage.
Inclusion Criteria:
- The patient must have SCS implanted for at least 2 months before study start date
- The patient must be at least 18 years old
- The patient must currently be receiving pain relief from SCS usage
- The patient must be willing to participate in a 9-week study
- The patient must have at least 20% of battery life remaining in his/her spinal cord
stimulator
- The patient must be able to tolerate Vicodin-Extra Strength as well as Tylenol, but
can also take their own pain medication if it is not one of the two mentioned
Exclusion Criteria:
- The patient is pregnant or intends to become pregnant during the course of the study.
- The patient by report, and/or by physician assessment, exhibits any or all of the
following, which might bias reporting of treatment outcome:
A strong untreated dependency on prescription medication such as benzodiazepines and
narcotic analgesics.
A strong potential for secondary gain issues.
A significant, untreated psychiatric comorbidity.
- The patient possesses a coexisting clinically relevant or disabling chronic pain
problem not treated by SCS
- The patient has been diagnosed with unstable angina
- The patient receives a Karnofsky's performance score of <60
We found this trial at
2
sites
600 Old Country Rd # 541
Rockville Center, New York 11570
Rockville Center, New York 11570
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