Effect of Spinal Cord Stimulation on Pain Thresholds and Sensory Perception in Chronic Pain Patients.
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/17/2018 |
| Start Date: | June 2010 |
| End Date: | December 20, 2016 |
The purpose of this study is to better understand how the Spinal Cord Stimulator works in
relieving chronic pain.
The investigators are asking subject to take part in this study because who are chronic pain
patients who already have a Spinal Cord Stimulator (SCS) in place.
The investigators hypothesize that chronic pain patients will have higher heat pain threshold
and heat pain tolerance over the painful areas with the SCS on.
QST (Quantitative Sensory Testing, a heat/cold simulation test) might be an objective helpful
tool for prudent patient selection for an expensive and invasive procedure for future SCS
placement.
relieving chronic pain.
The investigators are asking subject to take part in this study because who are chronic pain
patients who already have a Spinal Cord Stimulator (SCS) in place.
The investigators hypothesize that chronic pain patients will have higher heat pain threshold
and heat pain tolerance over the painful areas with the SCS on.
QST (Quantitative Sensory Testing, a heat/cold simulation test) might be an objective helpful
tool for prudent patient selection for an expensive and invasive procedure for future SCS
placement.
Sixty subjects who already have an implanted SCS device for pain management at the MGH Center
for Pain Medicine and other Partners affiliated pain centers will be enrolled.
Inclusion Criteria:
1. Subject is 18 years or older.
2. Subject has an SCS device implanted for at least one month for pain control. This
requirement is set to ensure that the subject becomes familiarized with the therapy and
has recovered from the surgical implantation of the SCS device.
Exclusion Criteria:
1. Subject has neurological disease or a condition causing sensory deficit to the painful
area.
2. Subject had recent therapy that may influence QST results, e.g., neuroablative procedure
within two-months.
3. Subjects who are unable to travel to the study center.
It will be a one time outpatient visit study, which will include the following:
1. Brief pain history and Neurological examination
- Medical History (including medication use);
- Pain location, intensity, character and if known, etiology, duration;
- Maps of pain locations and paresthesia locations;
- Sensory neurological examination (e.g., alcohol swab, cotton swab, pinprick and
vibration);
- A check on routine vital signs (blood pressure, pulse, pulse oximetry).
2. QST will include the following:
- Warm sensation, heat pain threshold, heat pain tolerance and wind-up. A cut-off of
53°C for heat will be preset to avoid tissue damage.
- QST will be done on two areas; painful area and non-painful area without
paresthesia with the SCS turned off.
- Subject will then turn on SCS and a repeat QST will be performed on the painful and
non-painful areas.
- QST tests will be performed in a quiet room at temperature 25º 2° C. The time and
duration of the QST tests will be recorded.
QST will be performed at least 4 hours and no later than 6 hours after the last dose of long
acting opioid and after last SCS on time. In this way the investigators will try to avoid
recording possible end dose withdrawal and provide sufficient time for the subject to return
to baseline for their SCS therapy.
for Pain Medicine and other Partners affiliated pain centers will be enrolled.
Inclusion Criteria:
1. Subject is 18 years or older.
2. Subject has an SCS device implanted for at least one month for pain control. This
requirement is set to ensure that the subject becomes familiarized with the therapy and
has recovered from the surgical implantation of the SCS device.
Exclusion Criteria:
1. Subject has neurological disease or a condition causing sensory deficit to the painful
area.
2. Subject had recent therapy that may influence QST results, e.g., neuroablative procedure
within two-months.
3. Subjects who are unable to travel to the study center.
It will be a one time outpatient visit study, which will include the following:
1. Brief pain history and Neurological examination
- Medical History (including medication use);
- Pain location, intensity, character and if known, etiology, duration;
- Maps of pain locations and paresthesia locations;
- Sensory neurological examination (e.g., alcohol swab, cotton swab, pinprick and
vibration);
- A check on routine vital signs (blood pressure, pulse, pulse oximetry).
2. QST will include the following:
- Warm sensation, heat pain threshold, heat pain tolerance and wind-up. A cut-off of
53°C for heat will be preset to avoid tissue damage.
- QST will be done on two areas; painful area and non-painful area without
paresthesia with the SCS turned off.
- Subject will then turn on SCS and a repeat QST will be performed on the painful and
non-painful areas.
- QST tests will be performed in a quiet room at temperature 25º 2° C. The time and
duration of the QST tests will be recorded.
QST will be performed at least 4 hours and no later than 6 hours after the last dose of long
acting opioid and after last SCS on time. In this way the investigators will try to avoid
recording possible end dose withdrawal and provide sufficient time for the subject to return
to baseline for their SCS therapy.
Inclusion Criteria:
- Subject is 18 years or older.
- Subject has an SCS device implanted for at least one month for pain control. This
requirement is set to ensure that the subject becomes familiarized with the therapy
and has recovered from the surgical implantation of the SCS device.
Exclusion Criteria:
- Subject has neurological disease or a condition causing sensory deficit to the painful
area.
- Subject had recent therapy that may influence QST results, e.g., neuroablative
procedure within two-months.
- Subjects who are unable to travel to the study center.
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