Effect of Spinal Cord Stimulation on Pain Thresholds and Sensory Perception in Chronic Pain Patients.

NCT01137617 | Completed

• 1 other identifier: 2010P 000425
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

spinal cord stimualtor

Outcome Measures

Primary Outcomes (3)

• Warm Sensation (WS) Threshold- Pain Site

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Shihab Ahmed, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 20, 2016
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)