Trial results for a multimodal treatment for hemiplegic shoulder pain in stroke patients were posted on ClinicalTrials.gov on 2025-12-22. The study reported reductions in pain ranging from 2.1 to 3.9 units on a scale.

Background

Hemiplegic shoulder pain (HSP) is a common complication affecting up to 60% of stroke survivors with moderate to severe impairment. This condition can significantly hinder rehabilitation outcomes, impacting activities of daily living (ADLs) and overall quality of life (QoL). Existing treatments for HSP often fail to provide long-term pain relief. Researchers have explored intramuscular peripheral nerve stimulation (PNS), involving temporary percutaneous intramuscular electrodes to stimulate axillary nerve motor points, as a potential treatment approach.

Trial design

This completed study, which did not specify a phase, enrolled 96 participants. The trial investigated multimodal treatments for conditions including Stroke and Shoulder Pain. The intervention involved intramuscular peripheral nerve stimulation (PNS) combined with either physical therapy (PT) or sham-PT, and a control arm of sham-PNS combined with PT.

Key results

The outcome measured was the Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline, with results presented as least squares mean in units on a scale:

What this means

The trial results indicate varied changes in hemiplegic shoulder pain across the treatment groups. Negative values for the Brief Pain Inventory (BPI)-SF3 mean change from baseline suggest a reduction in pain, with the largest observed reduction being -3.9 units on a scale in the PNS + PT group. Other groups also showed pain reductions, such as -2.1 units in the PNS + sham-PT group and -3.1 units in the sham-PNS + PT group. However, some measurements also reported positive mean changes, such as 7.1 units in the PNS + PT group, 7.4 units in the PNS + sham-PT group, and 8.1 units in the sham-PNS + PT group, which would indicate an increase in pain from baseline. The presence of both positive and negative mean changes for the same outcome measure suggests complex or time-dependent effects that are not fully elucidated by the provided data points alone. Clinicians and researchers should consider the full spectrum of reported changes when evaluating the efficacy of these multimodal treatments for stroke-related shoulder pain.

Source

The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study "Multimodal Treatment for Hemiplegic Shoulder Pain" were posted on 2025-12-22 on clinicaltrials.gov.