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

ABSTRACT: 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.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).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.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.

SUBMITTER: Wilson RD

PROVIDER: S-EPMC4038163 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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

Wilson Richard D RD Gunzler Douglas D DD Bennett Maria E ME Chae John J

American journal of physical medicine & rehabilitation 20140101 1

<h4>Objective</h4>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.<h4>Design</h4>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 Inventor ...[more]

PMID: 24355994

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Project description:ObjectivesThis study was undertaken to estimate the cost-effectiveness of deep brain stimulation (DBS) compared with vagus nerve stimulation (VNS) and care as usual (CAU) for adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model.MethodsA Markov decision analytic model was constructed to estimate the lifetime cost-effectiveness of DBS compared with VNS and CAU. Transition probabilities were estimated from a randomized controlled trial, and assumptions were made in consensus with an expert panel. Primary outcomes were expressed as incremental costs per quality-adjusted life-year (QALY) and per responder. Univariate and probabilistic sensitivity analyses were conducted to characterize parameter uncertainty.ResultsIn DBS, 28.4% of the patients were responders, with an average of 21.38 QALYs per patient and expected lifetime health care costs of €187 791. VNS had fewer responders (22.3%), fewer QALYs (20.70), and lower lifetime costs (€156 871). CAU had the fewest responders (6.2%), fewest QALYs (18.74), and lowest total health care costs (€64 670). When comparing with CAU, incremental cost-effectiveness ratios (ICERs) showed that costs per QALY gained were slightly lower for DBS (€46 640) than for VNS (€47 155). When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS. Sensitivity analyses showed that ICERs were heavily dependent on assumptions regarding loss to follow-up in the respective clinical trial.SignificanceThis study suggests that, given current limited evidence, VNS and DBS are potentially cost-effective treatment strategies compared to CAU for patients with refractory epilepsy. However, results for DBS were heavily impacted by assumptions made to extrapolate nonresponse from the original trial. More stringent assumptions regarding nonresponse resulted in an ICER just above an acceptable willingness to pay threshold. Given the uncertainty surrounding the effectiveness of DBS and the large impact of assumptions related to nonresponse, further empirical research is needed to reduce uncertainty.

Project description:BackgroundHemiplegic Shoulder Pain (HSP) is among common complications occurring after stroke leading to disability. This study was conducted to compare the effects of electrical Interferential Current stimulation (IFC) and Electrical Acupuncture (EAC) on pain intensity, range of motion, and functional ability in patients with HSP and also comparing the two modalities regarding improvement of above indices.MethodsIn this randomized clinical trial, 46 patients with HSP caused by ischemic stroke were recruited and assigned into 2 groups. Conventional exercise trainings were applied for both groups. Group A received additional IFC with medium frequency of 4000 HZ, and Group B received additional EAC two times a week for a total of 10 sessions. Pain severity, daily function, and shoulder Range of Motion (ROM) were evaluated using Visual Analogue Scale (VAS), Shoulder Pain and Disability Index (SPADI), and goniometry, respectively before and 5 weeks after the treatment.ResultsBoth groups showed relative improvement in pain severity, SPADI score, and its subscales, and also active and passive shoulder ROM after the treatment. However, IFC group compared to EAC group had higher mean changes of active ROM in abduction (28.00 ± 3.81 vs. 12.25 ± 2.39) and functional subscale of SPADI (11.45 ± 1.88 vs. 5.80 ± 1.66) after the treatment. On the contrary, EAC group showed higher percentage of VAS changes (46.14 ± 6.88 vs. 34.28 ± 5.52), indicating better pain improvement compared to IFC group. Other parameters did not show significant difference between two groups.ConclusionBoth IFC and EAC caused short term improvement in functional state, increased motion, and decreased pain in patients with HSP. Although pain control was more evident in acupuncture group, IFC resulted in better effects on function and active ROM of abduction, and seems to have higher efficacy.Trial registrationThis clinical trial was registered in the Iranian Registry of Clinical Trials at 2016-07-16 with a registry number of IRCT201602153217N10.

Project description:BACKGROUND:Pain during labour is one of the most intense pain that women may experience in their lifetime. There are several non-pharmacological analgesic methods to relieve pain during labour, among them transcutaneous electrical nerve stimulation (TENS). TENS is a low-frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology, but it has also come to be used as an alternative treatment during labour. The purpose of this study is to investigate the pain-relieving effect of a TENS application during labour and to find out the most effective dose. METHODS:This study is a randomized, double-blind, placebo-controlled trial. TENS therapy was initiated at the beginning of the active phase of labour. Participants were randomly assigned to three groups (21 per group: two active TENS and one placebo). Active TENS 1 intervention consisted in a constant frequency of 100-Hz, 100-?s, active TENS 2 intervention consisted in a varying high-frequency (80-100 Hz), 350 ?s, and in a placebo group, participants were connected to the TENS unit without electrical stimulation. TENS was applied with two self-adhesive electrodes placed parallel to the spinal cord (T10-L1 and S2-S4 levels). The primary outcome was pain intensity (0-10 cm) measured on a visual analogue scale (VAS) at several stages (at baseline and at 10 and 30 min later). Secondary outcomes included women's satisfaction (via the Care in Obstetrics: Measure for Testing Satisfaction scale). RESULTS:Sixty-three women participated. Regarding baseline characteristics, no differences were found among the three groups. The active TENS 2 group obtained an improvement with clinically significant VAS results (-?2.9, 95% confidence interval -?4.1 to -?1.6, p?<? 0.001). Regarding satisfaction, the results also revealed better results in the active TENS than in the placebo group. CONCLUSIONS:TENS with high frequencies modified in time as well as high pulse width are effective for relieving labour pain, and they are well considered by pregnant participants. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03137251 . Registered on 2 May 2017.

Project description:BackgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.MethodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.ResultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).ConclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.Editor’s perspective

Project description:Hemiplegic shoulder pain is a frequent complication after stroke, leading to limited use of the affected arm. Neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) are two widely used interventions to reduce pain, but the comparative efficacy of these two modalities remains uncertain. The purpose of this research was to compare the immediate and retained effects of EMG-triggered NMES and TENS, both in combination with bilateral arm training, on hemiplegic shoulder pain and arm function of stroke patients.A single-blind, randomized controlled trial was conducted at two medical centers. Thirty-eight patients (25 males and 13 females, 60.75 ± 10.84 years old, post stroke duration 32.68 ± 53.07 months) who had experienced a stroke more than 3 months ago at the time of recruitment and hemiplegic shoulder pain were randomized to EMG-triggered NMES or TENS. Both groups received electrical stimulation followed by bilateral arm training 3 times a week for 4 weeks. The primary outcome measures included a vertical Numerical Rating Scale supplemented with a Faces Rating Scale, and the short form of the Brief Pain Inventory. The secondary outcome measures were the upper-limb subscale of the Fugl-Meyer Assessment, and pain-free passive shoulder range of motion. All outcomes were measured pretreatment, post-treatment, and at 1-month after post-treatment. Two-way mixed repeated measures ANOVAs were used to examine treatment effects.Compared to TENS with bilateral arm training, the EMG-triggered NMES with bilateral arm training was associated with lower pain intensity during active and passive shoulder movement (P?=0.007, P?=0.008), lower worst pain intensity (P = 0.003), and greater pain-free passive shoulder abduction (P?=0.001) and internal rotation (P?=0.004) at follow-up. Both groups improved in pain at rest (P?=0.02), pain interference with daily activities, the Fugl-Meyer Assessment, and pain-free passive shoulder flexion and external rotation post-treatment (P?<?0.001) and maintained the improvement at follow-up (P?<?0.001), except for resting pain (P?=0.08).EMG-triggered NMES with bilateral arm training exhibited greater immediate and retained effects than TENS with bilateral arm training with respect to pain and shoulder impairment for chronic and subacute stroke patients with hemiplegic shoulder pain.NCT01913509 .

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

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

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