Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
ConditionBrachial Plexus Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to see how much pain intensity is affected by high frequency spinal cord stimulation therapy in individuals with serious brachial plexus injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old
Neuropathic pain of the upper limb ≥ 3 months following brachial plexus avulsion injury.
Patients must be planned to undergo implantation of high-frequency spinal cord stimulation for the treatment of chronic neuropathic pain due to brachial plexus avulsion injury.
Disqualifiers
Pain that is non-neuropathic as defined by DN4 score <4.
Pregnant at the time of consideration for implant or planning to become pregnant during the study duration.
Active substance use disorder of any kind.
Active tobacco use.
Trial population
Adult patients with history of brachial plexus avulsion injury referred to the Pain Clinic for consideration of neuromodulation using high frequency neurostimulation will be considered.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Adults with pain due to brachial plexus avulsion injury
Trial outcomes
Primary outcomes
1
Change in neuropathic pain
Measured using the patient reported Neuropathic Pain Symptom Inventory (NPSI) which uses a scale of 0 = "have not felt such pain" and 10 = "feel it the worst" for a total score with a higher score indicates greater pain.
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months2
Change in multidimensional pain inventory
Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months3
Change in Douleur Neuropathique 4 (DN4) Questionnaire
Change in DN4 questionnaire to estimate the probability of neuropathic pain with seven questions asking patients about quality of pain and three questions for physical examination of pain. Questions are yes = 1 or no = 0 to obtain a patient's total score out of 10, higher scores indicate more probability of pain.
Time frame
baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months4
Change in pain intensity
Measured using the PROMIS-CAT pain intensity scale
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 monthsSecondary outcomes
1
Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score
Measured using the self-reported DASH 30-item questionnaire to assess the ability to perform activities. Total score on a scale of 0 indicating no disability to 100 indicating most serve disability
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months2
Assessment of the effectiveness of high frequency spinal cord stimulation in the above population in the improvement of quality of life as measured by validated patient-completed questionnaires.
Measured using the EQ-5D.
Time frame
baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months3
Change in mood
Measured using the Center for Epidemiologic Depression Studies - Depression Scale. A 20-item self-reported questionnaire using a scale of 0 (rarely or none of the time) and 3 (most or all of the time) for a total score with high scores indicating the presence of more
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months4
Change in pain experience
Change in self-reported 13-item Pain Catastrophizing scale of 0 (not at all) and 4 (all the time) for a total score with higher scores indicating higher levels of pain anxiety
Time frame
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov