- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01137617
Effect of Spinal Cord Stimulation on Pain Thresholds and Sensory Perception in Chronic Pain Patients. (SCS)
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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:
- 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.
It will be a one time outpatient visit study, which will include the following:
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).
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02114
- MGH Center for Translational Pain Research
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Tylko przypadek
- Perspektywy czasowe: Przekrojowe
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Warm Sensation (WS) Threshold- Pain Site
Ramy czasowe: WS threshold is assessed once at Visit 1
|
WS threshold is a type of Quantitative Sensory Test (QST).
A contact thermode was attached to the subject's painful area that has SCS coverage.
The thermode increased by 1°C/sec from a baseline of 32°C.
Subjects were instructed to stop stimulation when they first perceived a warm sensation.
Subjects performed this test with their SCS off and again with their SCS on.
|
WS threshold is assessed once at Visit 1
|
|
Heat Pain (HP) Threshold- Pain Site
Ramy czasowe: HP threshold is assessed once at Visit 1
|
Heat Pain threshold is a type of QST.
A contact thermode was attached to the subject's painful area that has SCS coverage.
The thermode increased by 1°C/sec from a baseline of 32°C.
Subjects were instructed to stop the stimulation when pain was first detected.
Subjects performed this test with their SCS off and again with their SCS on.
|
HP threshold is assessed once at Visit 1
|
|
Heat Pain Tolerance- Pain Site
Ramy czasowe: Heat Pain Tolerance is assessed once at Visit 1
|
Heat Pain threshold is a type of QST.
A contact thermode was attached to the subject's painful area that has SCS coverage.
The thermode increased by 1°C/sec from a baseline of 32°C.
Subjects were instructed to stop the stimulation when pain was no longer tolerable.
Subjects performed this test with their SCS off and again with their SCS on.
|
Heat Pain Tolerance is assessed once at Visit 1
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Shihab Ahmed, MD, Massachusetts General Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2010P 000425
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .