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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response

NCT02928055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-06-18

Study results available
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Summary

The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP) reduction due to treatment with peripheral nerve stimulation. We will explore the association of subject-specific clinical and demographic information and pain relief from PNS. We will explore the possible role of central sensitization mechanisms in perpetuating pain via measures of sensory and pain perception. Lastly, we will explore the dose-response association of muscle-contraction from PNS and pain reduction, completion of activities of daily living (ADLs), and improvement in quality of life.

Conditions

Interventions

DEVICE

Peripheral Nerve Stimulation

The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Case Western Reserve University

    collaborator OTHER

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Richard D Wilson, MD · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-08-31
Completion
2019-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928055 on ClinicalTrials.gov