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NCT02893267 · ClinicalTrials.gov registry record · NA

Multimodal Treatment for Hemiplegic Shoulder Pain

A NA study, sponsored by MetroHealth Medical Center.

Completed
Registry status
NA
Development phase
96
Enrollment target

NCT02893267 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 96 participants.

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The verdict

NCT02893267, a NA study, has completed, sponsored by MetroHealth Medical Center.

COMPLETED
Registry status
NA
Development phase
96 participants
Enrollment target

Study Summary

Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for HSP have been proposed, most do not result in long-term relief of pain. The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. However, physical therapy (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical community, the superiority of PNS to a course of PT must be demonstrated. The investigators completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus, the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice, may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief than PNS alone or PT alone. Mechanisms also will be explored.

Interventions

  • OTHER Physical Therapy
  • DEVICE Peripheral Nerve Stimulation
  • OTHER Sham-PT
  • DEVICE Sham-PNS

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2017-01
Est. Completion 2024-09-30
Phase NA

Sponsor

MetroHealth Medical Center

76 total trials

What the Registry Record Tells You About NCT02893267

The ClinicalTrials.gov registry entry for NCT02893267 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Physical Therapy is the first listed.

NCT02893267 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02893267 about?

NCT02893267 is a clinical study titled "Multimodal Treatment for Hemiplegic Shoulder Pain". Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke survivors. HSP is associated with poor rehabilitation outcomes, including interference with activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for HSP have been proposed, mos...

What is the current status of trial NCT02893267?

This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2017-01. Estimated completion is 2024-09-30.

What interventions are being tested in trial NCT02893267?

The interventions under investigation include: Physical Therapy (OTHER), Peripheral Nerve Stimulation (DEVICE), Sham-PT (OTHER), Sham-PNS (DEVICE).

Who is sponsoring clinical trial NCT02893267?

This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.