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NCT Number: NCT04733599

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

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.

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Key information

Conditions

Brachial Plexus Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

Primary outcomes

  1. Change in neuropathic pain

    Time frame: 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.

  2. Change in multidimensional pain inventory

    Time frame: 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

  3. Change in Douleur Neuropathique 4 (DN4) Questionnaire

    Time frame: 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.

  4. Change in pain intensity

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the PROMIS-CAT pain intensity scale

  5. Change in pain interference

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the PROMIS-CAT pain interference scale

Secondary outcomes

  1. Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score

    Time frame: 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

  2. 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.

    Time frame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using the EQ-5D.

  3. Change in mood

    Time frame: 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

  4. Change in pain experience

    Time frame: 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

  5. Change in pain anxiety

    Time frame: 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

  6. Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

    Measured using Quantitative Sensory Testing

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2021
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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