Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury

Recruiting

• Conditions: Brachial Plexus Injury

• Registration Number: NCT04733599
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

This single-site prospective observational cohort study will include all adults (\> 18 years old) with brachial plexus avulsion injury who are candidates for high frequency (HF10) spinal cord stimulation (SCS). We plan to prospectively observe patients who undergo implantation of HF10 SCS for the indication of chronic neuropathic pain of the upper limb following brachial plexus avulsion injury.

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-28
• Study Start: 2021-02-01
• Study First Posted: 2021-02-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.
• Use of moderate or high dose opioid medication (oral morphine equivalents >100 mg daily).
• Active, untreated major psychiatric disorder that might interfere with subject's ability to participate.
• Involvement in active litigation related to injury.
• Patient has not undergone conservative medical management for at least 3 months (including physical and/or occupational therapy and at least one trial of neuropathic pain medication).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in neuropathic pain	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	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.
Change in pain interference	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using the PROMIS-CAT pain interference scale
Change in Douleur Neuropathique 4 (DN4) Questionnaire	baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	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.
Change in multidimensional pain inventory	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living
Change in pain intensity	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using the PROMIS-CAT pain intensity scale

Secondary Outcome Measures

Name	Time	Method
Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	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
Change in pain anxiety	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using the self-reported Pain Anxiety Symptom Scale Short Form 20 to rate frequency of symptoms on a scale of 0 (never) to 5 (always) for a total score with higher score indicating high levels of pain-related anxiety
Change in mood	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	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
Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using Quantitative Sensory Testing
Change in pain experience	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	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
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.	baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months	Measured using the EQ-5D.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States