Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

MedtronicNeuro137 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable post-surgical back pain in adults.

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

137

Conditions

Failed Back Surgery Syndrome Post-laminectomy Syndrome

Interventions

PrimeAdvanced® neurostimulator systemDEVICE

Neurostimulator and associated components

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Have persistent back pain for at least 6 months * Had back surgery at least 6 months ago * Have tried pain medications and physical therapy * Read and understand written English or Spanish * Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation * Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements * Have an expected lifespan greater than 12 months Key Exclusion Criteria: * Have leg pain in addition to back pain. * Currently enrolled in or plan to enroll in another drug and/or device study * Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia * Have an active systemic infection or are immunocompromised * Will be exposed to diathermy or anticipate needing a full-body MRI scan * Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator * Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery

Locations (27)

Outcomes

Primary Outcomes

Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.

Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.

Time frame: Baseline to 3 months

Secondary Outcomes

Functional Disability

Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).

Time frame: Baseline to 3 months

Subject Satisfaction

Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.

Time frame: 3 months

Quality of Life: Physical

Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).

Data from ClinicalTrials.gov

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...and 17 more locations