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.

The effect of electrical stimulation on impairment of the painful post-stroke shoulder.

Background: Transcutaneous electrical nerve stimulation (TENS) and transcutaneous neuromuscular electrical stimulation (t-NMES) are commonly used therapies in the treatment of chronic hemiplegic shoulder pain. These treatments are often utilized during physical or occupational therapy sessions, yet research into the acute analgesic effects of TENS and t-NMES on hemiplegic shoulder pain and use during therapy is limited. Objective: To compare the acute effects of transcutaneous electrical nerve stimulation (TENS), transcutaneous neuromuscular electrical stimulation (t-NMES), and no stimulation on pain-free passive range of motion of the shoulder in subjects with hemiplegic shoulder pain. Methods: Prospective cohort study of 10 subjects randomly treated with t-NMES, TENS, and one non-stimulation experimental condition. Pain-free passive external rotation and abduction range of motion of the affected shoulder were measured during stimulation. Results: There was not a significant within-subject difference in pain-free range of motion for external rotation or abduction. Subject to subject differences explained the majority of the variability in pain-free range of motion. Conclusion: This pilot study is the first to measure pain-free passive range of motion during electrical stimulation. Our findings demonstrate the lack of an acute effect of TENS and t-NMES on pain reduction.

Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up.

OBJECTIVE: To explore the feasibility and safety of a single-lead, fully implantable peripheral nerve stimulation system for the treatment of chronic shoulder pain in stroke survivors. PARTICIPANTS: Participants with moderate to severe shoulder pain not responsive to conservative therapies for six months. METHODS: During the trial phase, which included a blinded sham introductory period, a percutaneous single-lead peripheral nerve stimulation system was implanted to stimulate the axillary nerve of the affected shoulder. After a three-week successful trial, participants received an implantable pulse generator with an electrode placed to stimulate the axillary nerve of the affected shoulder. Outcomes included pain, pain interference, pain-free external rotation range of motion, quality of life, and safety. Participants were followed for 24 months. RESULTS: Twenty-eight participants underwent trial stimulation and five participants received an implantable pulse generator. The participants who received the implantable generator experienced an improvement in pain severity (p = 0.0002). All five participants experienced a 50% or greater pain reduction at 6 and 12 months, and four experienced at least a 50% reduction at 24 months. There was an improvement in pain interference (p < 0.0001). There was an improvement in pain-free external ROM (p = 0.003). There were no serious adverse events related to the device or to the procedure. CONCLUSIONS: This case series demonstrates the safety and efficacy of a fully implantable axillary PNS system for chronic HSP. Participants experienced reduction in pain, reduction in pain interference, and improved pain-free external rotation ROM. There were no serious adverse events associated with the system or the procedure.

In Vitro Magnetic Resonance Imaging Evaluation of Fragmented, Open-Coil, Percutaneous Peripheral Nerve Stimulation Leads.

OBJECTIVE: Percutaneous peripheral nerve stimulation (PNS) is an FDA-cleared pain treatment. Occasionally, fragments of the lead (MicroLead, SPR Therapeutics, LLC, Cleveland, OH, USA) may be retained following lead removal. Since the lead is metallic, there are associated magnetic resonance imaging (MRI) risks. Therefore, the objective of this investigation was to evaluate MRI-related issues (i.e., magnetic field interactions, heating, and artifacts) for various lead fragments. METHODS: Testing was conducted using standardized techniques on lead fragments of different lengths (i.e., 50, 75, and 100% of maximum possible fragment length of 12.7 cm) to determine MRI-related problems. Magnetic field interactions (i.e., translational attraction and torque) and artifacts were tested for the longest lead fragment at 3 Tesla. MRI-related heating was evaluated at 1.5 Tesla/64 MHz and 3 Tesla/128 MHz with each lead fragment placed in a gelled-saline filled phantom. Temperatures were recorded on the lead fragments while using relatively high RF power levels. Artifacts were evaluated using T1-weighted, spin echo, and gradient echo (GRE) pulse sequences. RESULTS: The longest lead fragment produced only minor magnetic field interactions. For the lead fragments evaluated, physiologically inconsequential MRI-related heating occurred at 1.5 Tesla/64 MHz while under certain 3 Tesla/128 MHz conditions, excessive temperature elevations may occur. Artifacts extended approximately 7 mm from the lead fragment on the GRE pulse sequence, suggesting that anatomy located at a position greater than this distance may be visualized on MRI. CONCLUSIONS: MRI may be performed safely in patients with retained lead fragments at 1.5 Tesla using the specific conditions of this study (i.e., MR Conditional). Due to possible excessive temperature rises at 3 Tesla, performing MRI at that field strength is currently inadvisable.

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Low Back Pain: Two Clinical Case Reports of Sustained Pain Relief.

As the leading cause of disability among U.S. adults, chronic low back pain (LBP) is one of the most prevalent and challenging musculoskeletal conditions. Neuromodulation provides an opportunity to reduce or eliminate the use of opioids to treat chronic LBP, but the cost and invasiveness of existing methods have limited its broad adoption, especially earlier in the treatment continuum. The present case report details the results of a novel method of short-term percutaneous peripheral nerve stimulation (PNS) in 2 subjects with chronic LBP. At the end of the 1-month therapy, stimulation was discontinued and the leads were withdrawn. PNS produced clinically significant improvements in pain (62% average reduction in Brief Pain Inventory Question #5, average pain), and functional outcomes (73% reduction in disability, Oswestry Disability Index; 83% reduction in pain interference, Brief Pain Inventory). Both subjects reduced nonopioid analgesic use by 83%, on average, and the one subject taking opioids ceased using all opioids. The only adverse event was minor skin irritation caused by a topical dressing. The clinically significant improvements were sustained at least 4 months after start of therapy (79% average reduction in pain; both reported minimal disability; 100% reduction in opioids; 74% reduction nonopioids). The results reveal the utility of this novel, short-term approach and its potential as a minimally invasive neuromodulation therapy for use earlier in the treatment continuum to produce sustained pain relief and reduce or eliminate the need for analgesic medications, including opioids, as well as more expensive and invasive surgical or therapeutic alternatives.

Percutaneous peripheral nerve stimulation for treatment of shoulder pain after spinal cord injury: A case report.

CONTEXT: This describes the first person with spinal cord injury (SCI) treated with percutaneous peripheral nerve stimulation for chronic shoulder pain. FINDINGS: From baseline to one-week after treatment, the subject's worst pain in the last week, rated on a 0-10 numerical rating scale (BPI-SF3), decreased by 44%. Pain interference decreased and remained below baseline 12 weeks after the end of treatment. There was an associated improvement in the mental component of quality of life. CONCLUSION: This case demonstrates the feasibility of treating shoulder pain in patients with SCI with percutaneous PNS. To demonstrate efficacy further studies are required.

The Effect of Peripheral Nerve Stimulation on Shoulder Biomechanics: A Randomized Controlled Trial in Comparison to Physical Therapy.

OBJECTIVE: To establish the effects on shoulder biomechanics from a peripheral nerve stimulation (PNS) treatment compared to physical therapy (PT) in stroke survivors with chronic hemiplegic shoulder pain. DESIGN: Single-site, pilot, randomized controlled trial for adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-week treatment of single-lead PNS or physical therapy (PT). The outcomes included isometric shoulder abduction strength, pain-free shoulder external rotation range of motion (ROM), delay in initiation and termination of shoulder abduction electromyogram (EMG) activity, and the Fugl-Meyer Motor Assessment (upper extremity section). Outcomes were measured at baseline, and at weeks 1, 4, 12, and 16. RESULTS: Twenty-five participants were recruited, 13 to PNS and 12 to PT. There were significant improvements for both PNS and PT in maximum isometric shoulder abduction strength, pain-free external rotation ROM, and Fugl-Meyer Motor Assessment. There were no significant changes in delay of initiation or termination of deltoid EMG with either treatment. CONCLUSIONS: Both PNS and PT are capable of improving shoulder biomechanics in those with HSP, though changes in biomechanics alone do not account for the greater pain relief associated with PNS than PT.

Infection Rates of Electrical Leads Used for Percutaneous Neurostimulation of the Peripheral Nervous System.

BACKGROUND: Percutaneous neurostimulation of the peripheral nervous system involves the insertion of a wire "lead" through an introducing needle to target a nerve/plexus or a motor point within a muscle. Electrical current may then be passed from an external generator through the skin via the lead for various therapeutic goals, including providing analgesia. With extended use of percutaneous leads sometimes greater than a month, infection is a concern. It was hypothesized that the infection rate of leads with a coiled design is lower than for leads with a noncoiled cylindrical design. METHODS: The literature was retrospectively reviewed for clinical studies of percutaneous neurostimulation of the peripheral nervous system of greater than 2 days that included explicit information on adverse events. The primary endpoint was the number of infections per 1,000 indwelling days. RESULTS: Forty-three studies were identified that met inclusion criteria involving coiled (n = 21) and noncoiled (n = 25) leads (3 studies involved both). The risk of infection with noncoiled leads was estimated to be 25 times greater than with coiled leads (95% confidence interval [CI] 2 to 407, P = 0.006). The infection rates were estimated to be 0.03 (95% CI 0.01 to 0.13) infections per 1,000 indwelling days for coiled leads and 0.83 (95% CI 0.16 to 4.33) infections per 1,000 indwelling days for noncoiled leads (P = 0.006). CONCLUSIONS: Percutaneous leads used for neurostimulation of the peripheral nervous system have a much lower risk of infection with a coiled design compared with noncoiled leads: approximately 1 infection for every 30,000 vs. 1,200 indwelling days, respectively.

Neurostimulation for Postsurgical Analgesia: A Novel System Enabling Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation.

While neurostimulation-stimulation of the nervous system using electrical current-has been used to treat chronic pain, its use treating postsurgical pain has been limited. Here, we report on the clinical application of a novel investigational lead to provide analgesia following total knee arthroplasty. In 5 subjects, leads were inserted percutaneously using ultrasound guidance within 0.5 to 3.0 cm of the femoral and/or sciatic nerve(s). With the delivery of current, pain decreased an average of 63% at rest, with 4 of 5 subjects having relief of > 50%. During passive and active knee flexion, pain decreased an average of 14% and 50%, with 0/3 and 1/2 subjects attaining > 50% relief, respectively. Ultrasound-guided percutaneous peripheral nerve stimulation may be a practical modality for the treatment of postsurgical pain.

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.

Neuromuscular Electrical Stimulation for Motor Restoration in Hemiplegia.

This article reviews the most common therapeutic and neuroprosthetic applications of neuromuscular electrical stimulation (NMES) for upper and lower extremity stroke rehabilitation. Fundamental NMES principles and purposes in stroke rehabilitation are explained. NMES modalities used for upper and lower limb rehabilitation are described, and efficacy studies are summarized. The evidence for peripheral and central mechanisms of action is also summarized.

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.

Control of robotic assistance using poststroke residual voluntary effort.

Poststroke hemiparesis limits the ability to reach, in part due to involuntary muscle co-activation (synergies). Robotic approaches are being developed for both therapeutic benefit and continuous assistance during activities of daily living. Robotic assistance may enable participants to exert less effort, thereby reducing expression of the abnormal co-activation patterns, which could allow participants to reach further. This study evaluated how well participants could perform a reaching task with robotic assistance that was either provided independent of effort in the vertical direction or in the sagittal plane in proportion to voluntary effort estimated from electromyograms (EMG) on the affected side. Participants who could not reach targets without assistance were enabled to reach further with assistance. Constant anti-gravity force assistance that was independent of voluntary effort did not reduce the quality of reach and enabled participants to exert less effort while maintaining different target locations. Force assistance that was proportional to voluntary effort on the affected side enabled participants to exert less effort and could be controlled to successfully reach targets, but participants had increased difficulty maintaining a stable position. These results suggest that residual effort on the affected side can produce an effective command signal for poststroke assistive devices.

Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report.

This case report describes the first participant treated with a fully implantable, single-lead peripheral nerve stimulation system for refractory hemiplegic shoulder pain. During the 6-wk trial stage, a temporary lead was placed percutaneously near the terminal branches of the axillary nerve to the deltoid. The primary outcome measure was the Brief Pain Inventory-Short Form Question 3, a 0-10 pain numeric rating scale. The participant experienced 75% pain reduction and proceeded to the implantation stage, where he received a single-lead, implantable pulse generator. After 3 wks, the participant became pain-free. However, 7 wks after implantation, the system was turned off because of an unrelated acute medical illness. Hemiplegic shoulder pain reemerged with a Brief Pain Inventory-Short Form Question 3 score of 9. After 11 wks of recovery, peripheral nerve stimulation was reinitiated and the participant became pain-free through the 9-mo follow-up. At 12 mos, Brief Pain Inventory-Short Form Question 3 score was 1. This case report demonstrates the feasibility of a single-lead, fully implantable peripheral nerve stimulation system for refractory hemiplegic shoulder pain.

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.

Contralaterally controlled functional electrical stimulation for recovery of elbow extension and hand opening after stroke: a pilot case series study.

OBJECTIVE: The aims of this study were to determine whether patients with moderate-to-severe upper limb hemiplegia could use contralaterally controlled functional electrical stimulation at the arm and hand (Arm+Hand CCFES) at home and to evaluate the feasibility of Arm+Hand CCFES to reduce arm and hand motor impairment. DESIGN: With Arm+Hand CCFES, the paretic elbow and hand extensors were stimulated with intensities proportional to the degree of elbow extension and hand opening, respectively, of the contralateral unimpaired side. For 12 wks, four participants with chronic (≥6 mos) upper limb hemiplegia received ∼7 hrs per week of self-administered home-based stimulation-mediated elbow extension and hand opening exercise plus ∼2.5 hrs per week of therapist-supervised laboratory-based stimulation-assisted functional task practice. Assessments of upper limb impairment were made at pretreatment, posttreatment, and 1 mo after treatment. RESULTS: All four participants were able to use the Arm+Hand CCFES system at home either independently or with very minimal assistance from a caregiver. All four participants had increases in the Fugl-Meyer score (1-9 points) and the Wolf Motor Function Test (0.2-0.8 points) and varying degrees of improvement in maximum hand opening, maximum elbow extension, and simultaneous elbow extension and hand opening. CONCLUSIONS: Arm+Hand CCFES can be successfully administered in stroke patients with moderate-to-severe impairment and can reduce various aspects of upper limb impairment. A larger efficacy study is warranted.

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.

Functional electrical stimulation to augment poststroke reach and hand opening in the presence of voluntary effort: a pilot study.

BACKGROUND: Hemiparesis after stroke can severely limit an individual's ability to perform activities of daily living. Functional electrical stimulation (FES) has the potential to generate functional arm and hand movements. We have observed that FES can produce functional hand opening when a stroke patient is relaxed, but the FES-produced hand opening is often overpowered by finger flexor coactivation in response to patient attempts to reach and open the hand. OBJECTIVE: To determine if stimulating both reaching muscles and hand opening muscles makes it possible to achieve useful amounts of simultaneous reach and hand opening even in the presence of submaximal reaching effort. METHODS: We measured reach and hand opening during a reach-then-open the hand task under different combinations of voluntary effort and FES for both reach and hand opening. RESULTS: As effort was reduced and stimulation generated more movement, a greater amount of reach and hand opening was achieved. For the first time, this study quantified the effect of voluntary effort for reach and hand opening on stimulated hand opening. It also showed variability in the interaction of voluntary effort and stimulation between participants. Additionally, when participants were instructed to reach with partial effort during simultaneous FES, they achieved greater reach and hand opening. CONCLUSIONS: Simultaneous reaching and FES hand opening is improved by including FES for reach and reducing voluntary effort. In the future, an upper extremity neuroprosthesis that uses a combination of voluntary effort and FES assistance may enable users to perform activities of daily living.