The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain.

BACKGROUND: Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refractory to conservative treatment. For patients who fail conservative treatment, there is no established treatment to successfully treat their chronic pain. Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain. This is the first controlled trial to utilize the same novel technology to treat shoulder impingement syndrome outside of the stroke population. METHODS: This is a dual-site, placebo-controlled, double-blinded, randomized control trial. Participants will be randomized to two treatment groups. The intervention group will be treated with active peripheral nerve stimulation of the axillary nerve of the affected shoulder and the control group will be treated with sham peripheral nerve stimulation of the axillary nerve of the affected shoulder. Both groups will receive a standardized exercise therapy program directed by a licensed therapist. DISCUSSION: This study protocol will allow the investigators to determine if this novel, non-pharmacologic treatment of shoulder pain can demonstrate the same benefit in musculoskeletal patients which has been previously demonstrated in the stroke population. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03752619. Registered on 26 November 2018.

Adding Contralaterally Controlled Electrical Stimulation of the Triceps to Contralaterally Controlled Functional Electrical Stimulation of the Finger Extensors Reduces Upper Limb Impairment and Improves Reachable Workspace but not Dexterity: A Randomized Controlled Trial.

OBJECTIVE: Different methods of neuromuscular electrical stimulation may be used for poststroke upper limb rehabilitation. This study evaluated the effects of contralaterally controlled functional electrical stimulation of the triceps and finger extensors. DESIGN: This is a randomized controlled trial of 67 participants who were less than 2 yrs poststroke and assigned to the following: (a) arm + hand contralaterally controlled functional electrical stimulation, (b) hand contralaterally controlled functional electrical stimulation, or (c) arm + hand cyclic neuromuscular electrical stimulation. Participants were prescribed 10 sessions/week of assigned electrical stimulation at home plus 24 sessions of functional task practice in the laboratory for 12 wks. The primary outcome measure was the Box and Blocks Test. Secondary measures included reachable workspace, Upper Extremity Fugl-Meyer, Stroke Upper Limb Capacity Scale, Arm Motor Abilities Test, and Motor Activity Log. RESULTS: There were no significant between-group differences on the Box and Blocks Test. At 6 mos after treatment, arm + hand contralaterally controlled functional electrical stimulation improved reachable workspace more than hand contralaterally controlled functional electrical stimulation, between-group difference of 264 (95% confidence interval = 28-500) cm and more than arm + hand cyclic neuromuscular electrical stimulation, between-group difference of 281 (95% confidence interval = 22-540) cm. Arm + hand contralaterally controlled functional electrical stimulation improved Upper Extremity Fugl-Meyer score more than hand contralaterally controlled functional electrical stimulation, between-group difference of 6.7 (95% confidence interval = 0.6-12.7). The between-group differences on the Stroke Upper Limb Capacity Scale and Arm Motor Abilities Test were not significant. CONCLUSIONS: Adding contralaterally controlled elbow extension to hand contralaterally controlled functional electrical stimulation does not improve on gains in hand dexterity, but it further reduces upper limb impairment and improves reachable workspace measured in the laboratory. However, these additional benefits may not be large enough to be perceived by stroke survivors when they are performing activities of daily living at home.

Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial.

BACKGROUND AND PURPOSE: It is unknown whether one method of neuromuscular electrical stimulation for poststroke upper limb rehabilitation is more effective than another. Our aim was to compare the effects of contralaterally controlled functional electrical stimulation (CCFES) with cyclic neuromuscular electrical stimulation (cNMES). METHODS: Stroke patients with chronic (>6 months) moderate to severe upper extremity hemiparesis (n=80) were randomized to receive 10 sessions/wk of CCFES- or cNMES-assisted hand opening exercise at home plus 20 sessions of functional task practice in the laboratory for 12 weeks. The task practice for the CCFES group was stimulation assisted. The primary outcome was change in Box and Block Test (BBT) score at 6 months post treatment. Upper extremity Fugl-Meyer and Arm Motor Abilities Test were also measured. RESULTS: At 6 months post treatment, the CCFES group had greater improvement on the BBT, 4.6 (95% confidence interval [CI], 2.2-7.0), than the cNMES group, 1.8 (95% CI, 0.6-3.0), between-group difference of 2.8 (95% CI, 0.1-5.5), P=0.045. No significant between-group difference was found for the upper extremity Fugl-Meyer (P=0.888) or Arm Motor Abilities Test (P=0.096). Participants who had the largest improvements on BBT were <2 years post stroke with moderate (ie, not severe) hand impairment at baseline. Among these, the 6-month post-treatment BBT gains of the CCFES group, 9.6 (95% CI, 5.6-13.6), were greater than those of the cNMES group, 4.1 (95% CI, 1.7-6.5), between-group difference of 5.5 (95% CI, 0.8-10.2), P=0.023. CONCLUSIONS: CCFES improved hand dexterity more than cNMES in chronic stroke survivors. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00891319.

Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation.

BACKGROUND AND PURPOSE: This study compared the effect of cyclic neuromuscular electrical stimulation (NMES), electromyographically (EMG)-triggered NMES, and sensory stimulation on motor impairment and activity limitations in patients with upper-limb hemiplegia. METHODS: This was a multicenter, single-blind, multiarm parallel-group study of nonhospitalized hemiplegic stroke survivors within 6 months of stroke. A total of 122 individuals were randomized to receive either cyclic NMES, EMG-triggered NMES, or sensory stimulation twice every weekday in 40-minute sessions, over an 8 week-period. Patients were followed for 6 months after treatment concluded. RESULTS: There were significant increases in the Fugl-Meyer Assessment [F(1, 111) = 92.6, P < .001], FMA Wrist and Hand [F(1, 111) = 66.7, P < .001], and modified Arm Motor Ability Test [mAMAT; time effect: F(1, 111) = 91.0, P < .001] for all 3 groups. There was no significant difference in the improvement among groups in the FMA [F(2, 384) = 0.2, P = .83], FMA Wrist and Hand [F(2, 384) = 0.4, P = .70], or the mAMAT [F(2, 379) = 1.2, P = .31]. CONCLUSIONS: All groups exhibited significant improvement of impairment and functional limitation with electrical stimulation therapy applied within 6 months of stroke. Improvements were likely a result of spontaneous recovery. There was no difference based on the type of electrical stimulation that was administered.

Effects of Patient Centered Interventions on Persistent Urinary Incontinence after Prostate Cancer Treatment: A Randomized, Controlled Trial.

PURPOSE: We examined whether an intervention combining pelvic floor muscle exercise and symptom self-management would improve urinary continence and quality of life in patients with prostate cancer. MATERIALS AND METHODS: In a randomized, controlled, longitudinal clinical trial 279 patients with prostate cancer with persistent urinary incontinence were randomized to 1 of 3 groups, including biofeedback pelvic floor muscle exercise plus a support group, the biofeedback exercise plus telephone contact and usual care without intervention. The biofeedback plus support and plus telephone groups received 1 session of biofeedback assisted exercise and 6 biweekly sessions of problem solving therapy. This delivered symptom management skills through a peer support group or telephone contacts for 3 months. All subjects were assessed in blinded fashion at baseline, and 3 and 6 months for urinary leakage frequency, leakage amount and disease specific quality of life. RESULTS: A total of 244 subjects completed the study. The biofeedback plus support and biofeedback plus telephone groups had a lower frequency of daily urinary leakage than the group with usual care without intervention at 3 months (p=0.019 and p≤0.001, respectively) but not at 6 months. The biofeedback plus support group but not the biofeedback plus telephone group had 13.3 gm lower leakage at 6 months than the usual care group (p=0.003). Overall the biofeedback plus support and plus telephone groups reported less symptom severity (p≤0.001) and fewer incontinence problems (p≤0.01) than the usual care group at 6 months. CONCLUSIONS: Study findings show that pelvic floor muscle exercise practice plus symptom self-management in a peer support setting can significantly improve urinary continence and quality of life in patients with prostate cancer.

Surface peroneal nerve stimulation in lower limb hemiparesis: effect on quantitative gait parameters.

OBJECTIVE: The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis. DESIGN: This study is a randomized controlled clinical trial. SETTING: The setting of this study is a teaching hospital of an academic medical center. PARTICIPANTS: One hundred ten chronic stroke survivors (>12 wks poststroke) with unilateral hemiparesis participated in this study. INTERVENTIONS: The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention. The subjects were treated for 12 wks and followed up for 6-mo posttreatment. MAIN OUTCOME MEASURES: Spatiotemporal, kinematic, and kinetic parameters of gait were the main outcome measures. RESULTS: Cadence (F3,153 = 5.81, P = 0.012), stride length (F3,179 = 20.01, P < 0.001), walking speed (F3,167 = 18.2, P < 0.001), anterior-posterior ground reaction force (F3,164 = 6.61, P = 0.004), peak hip power in preswing (F3,156 = 8.76, P < 0.001), and peak ankle power at push-off (F3,149 = 6.38, P = 0.005) all improved with respect to time. However, peak ankle ankle dorsiflexion in swing (F3,184 = 4.99, P = 0.031) worsened. In general, the greatest change for all parameters occurred during the treatment period. There were no significant treatment group × time interaction effects for any of the spatiotemporal, kinematic, or kinetic parameters. CONCLUSIONS: Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off, which may have resulted in improved cadence, stride length, and walking speed; however, there were no differences between treatment groups. Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing, although the clinical implications of this finding are unclear.

Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series.

OBJECTIVE: The objective of this study was to determine the effect of peripheral nerve stimulation (PNS) on pain reduction for those with refractory subacromial impingement syndrome (SIS) and to evaluate the association with reduced disability, impairment, and safety. Our hypotheses are that PNS will be associated with a reduction in pain, impairment and disability, and improvement in quality of life while demonstrating safety. MATERIAL AND METHODS: Adults with shoulder pain of at least six months duration were recruited for a three-week treatment of percutaneous PNS applied through a percutaneous electrode to the axillary motor points of the deltoid muscle. Subjects were followed for 12 weeks after treatment. The primary outcome was the worst pain in the last week, and secondary outcomes included pain interference, the Disabilities of the Arm, Shoulder, and Hand questionnaire, shoulder abduction range of motion, and safety. Analysis was with a linear mixed model. RESULTS: Ten subjects were recruited. Longitudinal analysis demonstrated significant reduction in pain relative to baseline (F(1, 66) = 12.9, p < 0.01). After correcting for multiple comparisons, there were significant reductions at explantation and all follow-up time points when compared with baseline. There were also significant improvements in pain interference (F(1,65) = 15.0, p < 0.01), the Disabilities of the Arm, Shoulder, and Hand questionnaire (F(1,35) = 7.0, p = 0.01), and shoulder abduction range of motion (F(1,35) = 6.3, p = 0.02). CONCLUSION: Intramuscular PNS for chronic shoulder pain due to SIS is a safe treatment associated with pain reduction, lower pain interference with activities of daily living, reduced disability, and improved shoulder abduction. Pain reduction is maintained for at least 12 weeks after treatment.

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

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.

Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia.

OBJECTIVE: The aim of this study was to compare the effects of contralaterally controlled neuromuscular electrical stimulation (CCNMES) vs. cyclic neuromuscular electrical stimulation (NMES) on lower extremity impairment, functional ambulation, and gait characteristics. DESIGN: Twenty-six survivors of stroke with chronic (≥6 mos) foot drop during ambulation were randomly assigned to 6 wks of CCNMES or cyclic NMES. Both groups had ten sessions per week of self-administered home application of either CCNMES or cyclic NMES plus two sessions per week of gait training with a physical therapist. Primary outcomes included lower extremity Fugl-Meyer score, modified Emory Functional Ambulation Profile, and gait velocity. Assessments were made at pretreatment and posttreatment and at 1 and 3 mos after treatment. RESULTS: There were no significant differences between the groups in the outcome trajectories for any of the measures. With data from both groups pooled, there were significant but modest and sustained improvements in the Fugl-Meyer score and the modified Emory Functional Ambulation Profile but not in gait velocity. CONCLUSIONS: The results support the hypothesis that gait training combined with either CCNMES or cyclic NMES reduces lower extremity impairment and functional ambulation but do not support the hypothesis that CCNMES is more effective than cyclic NMES in patients with chronic post-stroke hemiplegia.

Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis.

OBJECTIVE: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. DESIGN: Single-blinded randomized controlled trial. SETTING: Teaching hospital of academic medical center. PARTICIPANTS: Chronic stroke survivors (N=110; >12wk poststroke) with unilateral hemiparesis and dorsiflexion strength of ≤4/5 on the Medical Research Council scale. INTERVENTIONS: Subjects were stratified by motor impairment level and then randomly assigned to ambulation training with either a surface PNS device or usual care (ankle-foot orthosis or no device) intervention. Subjects were treated for 12 weeks and followed up for 6 months posttreatment. MAIN OUTCOME MEASURES: Lower limb portion of the Fugl-Meyer (FM) Assessment (motor impairment), the modified Emory Functional Ambulation Profile (mEFAP) performed without a device (functional ambulation), and the Stroke Specific Quality of Life (SSQOL) scale. RESULTS: There was no significant treatment group main effect or treatment group by time interaction effect on FM, mEFAP, or SSQOL raw scores (P>.05). The time effect was significant for the 3 raw scores (P<.05). However, when comparing average change scores from baseline (t1) to end of treatment (t2, 12wk), and at 12 weeks (t3) and 24 weeks (t4) after end of treatment, significant differences were noted only for the mEFAP and SSQOL scores. The change in the average scores for both mEFAP and SSQOL occurred between t1 and t2, followed by relative stability thereafter. CONCLUSIONS: There was no evidence of a motor relearning effect on lower limb motor impairment in either the PNS or usual-care groups. However, both the PNS and usual-care groups demonstrated significant improvements in functional mobility and quality of life during the treatment period, which were maintained at 6-month follow-up.