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

Brachial Plexus Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733599
• Other study ID #: 20-000910
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Primary	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	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Primary	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.	baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Primary	Change in pain intensity	Measured using the PROMIS-CAT pain intensity scale	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Primary	Change in pain interference	Measured using the PROMIS-CAT pain interference scale	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	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.	baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	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	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	Change in pain anxiety	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	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary	Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.	Measured using Quantitative Sensory Testing	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months