Chronic Pain, Complex Regional Pain Syndromes, Failed Back Surgery Syndrome, Neuropathic Pain
Conditions
Keywords
Spinal cord stimulation
Brief summary
Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.
Interventions
DEVICESpinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Sponsors
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
There will be two research teams. One team will be unblinded (e.g., clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g., research personnel) and will perform clinical testing and collect study outcome measures.
Intervention model description
Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic intractable pain of the trunk and/or limbs * Undergoing SCS as part of standard clinical care for chronic pain management * Candidates will have been implanted with a commercial SCS device * Candidates who are 18 years or older and can speak, read, and understand English * Able to understand study procedures and to comply with them for the entire length of the study * Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit * Must be willing to wear a face-covering during all study visits
Exclusion criteria
* Subjects who are pregnant or nursing * Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail * Subjects who are unable or unwilling to cooperate with clinical testing * Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol * Inability or unwillingness of individual or legal guardian/representative to give written informed consent * Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) | Up to 30 days | TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott Lempka, PhD
University of Michigan
Participant flow
Recruitment details
Recruitment period was between October 2021 - May 2024.
Pre-assignment details
34 participants were enrolled but only 25 were randomized. 4 participants no longer met the inclusion criteria, 4 participants were lost to follow-up and 1 participant was withdrawn.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 3 / 25 | 0 / 24 | 0 / 24 | 2 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
None listed