Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
neurologically stable (>1 year post SCI)
medical clearance to participate
ability to stand with or without an assistive device for at least 3 minutes at a time
expectation that current medication will be maintained without change for at least 3 months (stable use of anti-spasticity medication is accepted)
Disqualifiers
motoneuron injury
known cardiac condition
medically unstable condition (incl. pregnancy)
cognitive impairment
Trial design
Design model
Single group
Treatments tested in this trial
Operant Conditioning of Cutaneous Reflexes
BehavioralThis is a training intervention in which people with a spinal cord injury are trained to change (increase or decrease) the activity of a certain spinal reflex. By changing this reflex, it is hypothesized that individuals can reduce pain due to spinal cord injury.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Operant Conditioning of Cutaneous ReflexesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)
This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the participant is barely able to perceive the sensation. A decrease in this threshold would demonstrate improved sensation.
Time frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up2
Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the sensation covers the maximum skin area). A decrease in this threshold indicates improved sensation.
Time frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up3
Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)
This is measured by slowly increasing the nerve stimulation and recording the intensity of stimulation at which the stimulation first becomes painful. An increase in this threshold indicates an increased tolerance to pain.
Time frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up4
Change in pain as measured by the McGill Pain Questionnaire (MPQ)
The MPQ is a self-report questionnaire that assesses quality and intensity of pain. Scores range from 0 (no pain) to 78 (severe pain).
Time frame
Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow upSecondary outcomes
1
Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)
The QST is a battery of assessments that measure sensory thresholds for pain, touch, vibration, and hot and cold temperature sensations.
Time frame
Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up2
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
An increase in the the score on the SCIM III indicates increased basic functional independence. This is a self report questionnaire with 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, subscore 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100, with higher scores indicated increase independence.
Time frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up3
Change in functional independence as measured by the Functional Independence Measure (FIM)
An increase in the score on the FIM indicates and increase in functional independence. This 18-item, clinician-reported scale assesses function in 6 areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence).
Time frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up4
Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
An increase in score on the SCI-QOL indicates an increase in quality of life
Time frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov