Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial

Abstract

Objective: This study sought to establish the efficacy of single-lead, 3-wk peripheral nerve stimulation (PNS) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain.

Design: This study is a single-site, pilot, randomized controlled trial of adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-wk treatment of single-lead PNS or usual care. The primary outcome was the worst pain in the last week (Brief Pain Inventory, Short Form, question 3) measured at baseline and weeks 1, 4, 12, and 16. The secondary outcomes included pain interference (Brief Pain Inventory, Short Form, question 9), pain measured by the ShoulderQ Visual Graphic Rating Scales, and health-related quality-of-life (Short-Form 36 version 2).

Results: Twenty-five participants were recruited, 13 to PNS and 12 to usual care. There was a significantly greater reduction in pain for the PNS group compared with the controls, with significant differences at 6 and 12 wks after treatment. Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life.

Conclusions: Short-term PNS is a safe and efficacious treatment of shoulder pain. Pain reduction is greater compared with usual care and is maintained for at least 12 wks after treatment.

Trial registration: ClinicalTrials.gov NCT01123382.

Figures

Figure 1

Participant flow diagram.

Figure 2

Graphical comparison of: A) the worst pain in 1 week on 0–10 scale, Brief Pain Inventory, Short Form question 3; B) Pain interference on a 0 – 10 scale, Brief Pain Inventory, Short Form question 9; C) the summed Visual Graphic Rating Scale from the ShoulderQ questionnaire; and, D) the Bodily Pain domain of the SF-36v2. PNS is represented by the solid line and UC the dashed line. The period of treatment is represented by the shaded area. *=statistically significant differences between PNS and UC using Bonferroni correction for multiple comparisons.

Figure 2

Graphical comparison of: A) the worst pain in 1 week on 0–10 scale, Brief Pain Inventory, Short Form question 3; B) Pain interference on a 0 – 10 scale, Brief Pain Inventory, Short Form question 9; C) the summed Visual Graphic Rating Scale from the ShoulderQ questionnaire; and, D) the Bodily Pain domain of the SF-36v2. PNS is represented by the solid line and UC the dashed line. The period of treatment is represented by the shaded area. *=statistically significant differences between PNS and UC using Bonferroni correction for multiple comparisons.

Figure 2

Graphical comparison of: A) the worst pain in 1 week on 0–10 scale, Brief Pain Inventory, Short Form question 3; B) Pain interference on a 0 – 10 scale, Brief Pain Inventory, Short Form question 9; C) the summed Visual Graphic Rating Scale from the ShoulderQ questionnaire; and, D) the Bodily Pain domain of the SF-36v2. PNS is represented by the solid line and UC the dashed line. The period of treatment is represented by the shaded area. *=statistically significant differences between PNS and UC using Bonferroni correction for multiple comparisons.

Figure 2

Graphical comparison of: A) the worst pain in 1 week on 0–10 scale, Brief Pain Inventory, Short Form question 3; B) Pain interference on a 0 – 10 scale, Brief Pain Inventory, Short Form question 9; C) the summed Visual Graphic Rating Scale from the ShoulderQ questionnaire; and, D) the Bodily Pain domain of the SF-36v2. PNS is represented by the solid line and UC the dashed line. The period of treatment is represented by the shaded area. *=statistically significant differences between PNS and UC using Bonferroni correction for multiple comparisons.

Figure 3

Successful outcomes (30% reduction in pain by end of treatment maintained at all remaining time points) for PNS and UC groups.