Automated, Patient-interactive, Spinal Cord Stimulator Adjustment: A Randomized Controlled Trial

Neurosurgery ◽  
2003 ◽  
Vol 52 (3) ◽  
pp. 572-580 ◽  
Author(s):  
Richard B. North ◽  
Sherri-Kae Calkins ◽  
David S. Campbell ◽  
Jeffrey M. Sieracki ◽  
Steven Piantadosi ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Controlled Trial ◽  
Cost Savings ◽  
Automated System ◽  
Automated Testing ◽  
Interactive System ◽  
Battery Life ◽  
Analog Scale ◽  
Manual Testing

Abstract OBJECTIVE Programmable, multicontact, implanted stimulation devices represent an important advance in spinal cord stimulation for the management of pain. They facilitate the technical goal of covering areas of pain by stimulation-evoked paresthesiae. Adjustment after implantation requires major investments of time and effort, however, if the capabilities of these devices are to be used to full advantage. The objective of maximizing coverage should be met while using practitioners' time efficiently. METHODS We have developed a patient-interactive, computerized system designed for greater ease and safety of operation, compared with the standard external devices used to control and adjust implanted pulse generators. The system automatically and rapidly presents to the patient the contact combinations and pulse parameters specified by the practitioner. The patient adjusts the amplitude of stimulation and then records drawings of stimulation paresthesiae (for comparison with pain drawings), followed by visual analog scale ratings for each setting. Test results are analyzed and sorted to determine the optimal settings. We compared the automated, patient-interactive system with traditional, practitioner-operated, manual programming methods in a randomized controlled trial at two study centers, with 44 patients. RESULTS The automated, patient-interactive system yielded significantly (P < 0.0001) better technical results than did traditional manual methods, in achieving coverage of pain by stimulation paresthesiae (mean 100-point visual analog scale ratings of 70 and 46, respectively). The visual analog scale ratings were higher for automated testing for 38 patients, higher for manual testing for 0 patients, and equal (tied) for 6 patients. Multivariate analysis demonstrated that the advantage of automated testing occurred independently of practitioner experience; the advantage was significantly greater, however, for experienced patients. The rate of testing (number of settings tested per unit time) was significantly (P < 0.0001) greater for the automated system, in comparison with the rate with a human operator using traditional, manual, programming methods (mean of 0.73 settings/min versus 0.49 settings/min). The automated system also identified settings with improved estimated battery life (and corresponding anticipated cost savings). No complications were observed with automated testing; one complication (transient discomfort attributable to excessive stimulation) occurred with manual testing. CONCLUSION Automated, patient-interactive adjustment of implanted spinal cord stimulators is significantly more effective and more efficient than traditional manual methods of adjustment. It offers not only improved clinical efficacy but also potential cost savings in extending implanted battery life. It has the additional potential advantages of standardization, quality control, and record keeping, to facilitate clinical research and patient care. It should enhance the clinical application of spinal cord stimulation for the treatment of chronic intractable pain.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Controlled Trial ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the spinal cord stimulation group (experimental group, EG) will undergo continuous stimulation. The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline in the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle.Discussion The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.

Burst Spinal Cord Stimulation

Neurosurgery ◽  
2010 ◽  
Vol 66 (5) ◽  
pp. 986-990 ◽  
Author(s):  
Dirk De Ridder ◽  
Sven Vanneste ◽  
Mark Plazier ◽  
Elsa van der Loo ◽  
Tomas Menovsky
Keyword(s):  
Spinal Cord ◽  
Neuropathic Pain ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Short Form ◽  
Burst Stimulation ◽  
Analog Scale ◽  
Tonic Stimulation ◽  
Better Than

Abstract INTRODUCTION Spinal cord stimulation is commonly used for neuropathic pain modulation. The major side effect is the onset of paresthesia. The authors describe a new stimulation design that suppresses pain as well as, or even better than, the currently used stimulation, but without creating paresthesia. METHODS A spinal cord electrode (Lamitrode) for neuropathic pain was implanted in 12 patients via laminectomy: 4 at the C2 level and 7 at the T8–T9 level for cervicobrachialgia and lumboischialgia, respectively (1 at T11 at another center). During external stimulation, the patients received the classic tonic stimulation (40 or 50 Hz) and the new burst stimulation (40-Hz burst with 5 spikes at 500 Hz per burst). RESULTS Pain scores were measured using a visual analog scale and the McGill Short Form preoperatively and during tonic and burst stimulation. Paresthesia was scored as present or not present. Burst stimulation was significantly better for pain suppression, by both the visual analog scale score and the McGill Short Form score. Paresthesia was present in 92% of patients during tonic stimulation, and in only 17% during burst stimulation. Average follow-up was 20.5 months. CONCLUSION The authors present a new method of spinal cord stimulation using bursts that suppress neuropathic pain without the mandatory paresthesia. Pain suppression seems as good as or potentially better than that achieved with the currently used stimulation. Average follow-up after nearly 2 years (20.5 months) suggests that this stimulation design is stable.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Control Group ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background: Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method：Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥ 5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), achievement rate of a desirable pain state (VAS score ≤ 4), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion：The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registration: NCT03858790, clinicaltrials.gov, registered on March 1st, 2019, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03858790

scholarly journals Strength-Training Protocols to Improve Deficits in Participants With Chronic Ankle Instability: A Randomized Controlled Trial

2015 ◽  
Vol 50 (1) ◽  
pp. 36-44 ◽  
Author(s):  
Emily A. Hall ◽  
Carrie L. Docherty ◽  
Janet Simon ◽  
Jackie J. Kingma ◽  
Joanne C. Klossner
Keyword(s):  
Strength Training ◽  
Visual Analog Scale ◽  
Ankle Instability ◽  
Controlled Trial ◽  
Chronic Ankle Instability ◽  
Control Group ◽  
Analog Scale ◽  
Protocol Group ◽  
Proprioceptive Neuromuscular Facilitation ◽  
Hop Test

Context: Although lateral ankle sprains are common in athletes and can lead to chronic ankle instability (CAI), strength-training rehabilitation protocols may improve the deficits often associated with CAI. Objective: To determine whether strength-training protocols affect strength, dynamic balance, functional performance, and perceived instability in individuals with CAI. Design: Randomized controlled trial. Setting: Athletic training research laboratory. Patients or Other Participants: A total of 39 individuals with CAI (17 men [44%], 22 women [56%]) participated in this study. Chronic ankle instability was determined by the Identification of Functional Ankle Instability Questionnaire, and participants were randomly assigned to a resistance-band–protocol group (n = 13 [33%] age = 19.7 ± 2.2 years, height = 172.9 ± 12.8 cm, weight = 69.1 ± 13.5 kg), a proprioceptive neuromuscular facilitation strength-protocol group (n = 13 [33%], age = 18.9 ± 1.3 years, height = 172.5 ± 5.9 cm, weight = 72.7 ± 14.6 kg), or a control group (n = 13 [33%], age = 20.5 ± 2.1 years, height = 175.2 ± 8.1 cm, weight = 70.2 ± 11.1 kg). Intervention(s): Both rehabilitation groups completed their protocols 3 times/wk for 6 weeks. The control group did not attend rehabilitation sessions. Main Outcome Measure(s): Before the interventions, participants were pretested by completing the figure-8 hop test for time, the triple-crossover hop test for distance, isometric strength tests (dorsiflexion, plantar flexion, inversion, and eversion), the Y-Balance test, and the visual analog scale for perceived ankle instability. Participants were again tested 6 weeks later. We conducted 2 separate, multivariate, repeated-measures analyses of variance, followed by univariate analyses on any significant findings. Results: The resistance-band protocol group improved in strength (dorsiflexion, inversion, and eversion) and on the visual analog scale (P < .05); the proprioceptive neuromuscular facilitation group improved in strength (inversion and eversion) and on the visual analog scale (P < .05) as well. No improvements were seen in the triple-crossover hop or the Y-Balance tests for either intervention group or in the control group for any dependent variable (P > .05). Conclusions: Although the resistance-band protocol is common in rehabilitation, the proprioceptive neuromuscular facilitation strength protocol is also an effective treatment to improve strength in individuals with CAI. Both protocols showed clinical benefits in strength and perceived instability. To improve functional outcomes, clinicians should consider using additional multiplanar and multijoint exercises.

scholarly journals The Effect of 1,8-Cineole Inhalation on Preoperative Anxiety: A Randomized Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Ka Young Kim ◽  
Hyo Jin Seo ◽  
Sun Seek Min ◽  
Mira Park ◽  
Geun Hee Seol
Keyword(s):  
Visual Analog Scale ◽  
Controlled Trial ◽  
Major Constituent ◽  
Control Group ◽  
Analog Scale ◽  
Almond Oil ◽  
Eucalyptus Oil ◽  
Significant Difference ◽  
Before And After ◽  
Selective Nerve Root Block

The aim of this study was to investigate the effect of inhalation of eucalyptus oil and its constituents on anxiety in patients before selective nerve root block (SNRB). This study was a randomized controlled trial carried out in 62 patients before SNRB. The patients were randomized to inhale limonene, 1,8-cineole, or eucalyptus oil, each at concentrations of 1% vol/vol in almond oil or almond oil (control). Anxiety-visual analog scale (A-VAS), state-trait anxiety inventory (STAI), profile of mood states (POMS), pain-visual analog scale (P-VAS), blood pressure, and pulse rate were measured before and after inhalation prior to SNRB. Measures of anxiety, including A-VAS (P<0.001), STAI (P=0.005), and POMS (P<0.001), were significantly lower in 1,8-cineole than in the control group and significantly greater in 1,8-cineole than in the eucalyptus group in A-VAS. P-VAS was significantly lower after than before inhalation of limonene, 1,8-cineole, and eucalyptus, despite having no significant difference in the four groups compared with control group. 1,8-Cineole, a major constituent of eucalyptus, was effective in decreasing anxiety before SNRB. The present findings suggest that inhalation of 1,8-cineole may be used to relieve anxiety before, during, and after various operations, in addition to SNRB.

scholarly journals Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-blind Controlled Trial

2020 ◽  
Author(s):  
huiming peng ◽  
wei wang ◽  
jin lin ◽  
xisheng weng ◽  
wenwei qian ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Visual Analog Scale ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Visual Analog Scale Score ◽  
Analog Scale ◽  
Double Blind ◽  
Total Knee ◽  
Double Blinded ◽  
Hss Score

Abstract Background: Multimodal cocktail periarticular injection(MCPI) including corticosteroids is currently widely applied to reduce postoperative pain and swelling following total knee arthroplasty (TKA). However the addition of steroids is controversial.This prospective, double-blinded, randomized, controlled trial compares the safety and efficacy of MCPI with or without corticosteroids.Methods: A total of 60 patients (120 knees) who underwent simultaneous bilateral TKAs received periarticular injections with added betamethasone (7mg) in a randomly selected knee, and the other knee was injected without added corticosteroids. The visual analog scale(VAS) pain scores at rest and in motion, range of motion (ROM), thigh swelling, hospital for special surgery(HSS) score, and adverse events were compared between the 2 knees.Results: There were no statistically significant differences in the visual analog scale score, ROM, thigh girth, HSS score, and complications between the 2 kness. The patients were unable to detect a difference in the functional recovery between their knees on postoperative day 3or at the 3 month follow-up.Conclusion: Betamethasone injections are ineffective locally for relieving pain, reducing swelling, and improving the postoperative ROM.Trial registration: Chinese Clinical Trial RegistryNumber: ChiCTR-OPC-17013503, Date of Registration: 2017-11-23 URL:http://www.chictr.org.cn/showproj.aspx?proj=23146

scholarly journals Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis: A Randomized Controlled Trial Comparing the Posterior Glenohumeral Recess and the Rotator Cuff Interval Approaches

2021 ◽  
Vol 12 ◽  
Author(s):  
Jia-Chi Wang ◽  
Po-Yi Tsai ◽  
Po-Cheng Hsu ◽  
Jian-Ru Huang ◽  
Kevin A. Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Range Of Motion ◽  
Triamcinolone Acetonide ◽  
Shoulder Pain ◽  
Visual Analog Scale ◽  
Controlled Trial ◽  
Adhesive Capsulitis ◽  
Analog Scale ◽  
Randomized Controlled

For patients with adhesive capsulitis, hydrodilatation is typically performed using corticosteroids with ultrasound guidance via the posterior glenohumeral recess. Recently, a new intervention technique via the rotator cuff interval has been described. This study aimed to compare the efficacy of hydrodilatation with triamcinolone acetonide via the posterior glenohumeral recess and the rotator cuff interval in patients with adhesive capsulitis. This prospective randomized controlled trial was conducted in a tertiary care center with a follow-up period of 12 weeks. We enrolled 64 patients diagnosed with shoulder adhesive capsulitis. The subjects were randomly assigned to two groups that received hydrodilatation with corticosteroids either through the posterior glenohumeral recess or though the rotator cuff interval. The injection contained 4 ml of triamcinolone acetonide (40 mg) mixed with 4 ml of 2% lidocaine hydrochloride and 12 ml of normal saline. The shoulder pain and disability index, visual analog scale for pain, and range of motion were analyzed before and at 6 and 12 weeks after the treatment. Both groups experienced improvements in the visual analog scale scores, shoulder pain and disability index scores, and range of motion throughout the study period. A significant group-time interaction was observed in terms of the visual analog scale for pain during motion (p = 0.019), favoring hydrodilatation through the rotator cuff interval. Thus, hydrodilatation through the rotator cuff interval might be a better treatment option than that through the posterior glenohumeral recess for patients with adhesive capsulitis, considering its superior effect in alleviating pain during shoulder movement.

The Effectiveness of the Mézières Method in Elite Rhythmic Gymnastics Athletes With Low Back Pain: A Randomized Controlled Trial

2020 ◽  
Vol 29 (7) ◽  
pp. 913-919
Author(s):  
Orges Lena ◽  
Jasemin Todri ◽  
Ardita Todri ◽  
José Luis Martínez Gil ◽  
Maria Gomez Gallego
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Visual Analog Scale ◽  
Effect Size ◽  
Controlled Trial ◽  
Low Back ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Rhythmic Gymnastics

Context: One of the main reasons why athletes with a high physical condition suffer from low back pain disease is because they often participate in sports that involve disc compression movements during flexion, lifting loads, or torsion movement. Objectives: This study aims to examine the effectiveness of the postural treatment of the Mézières method on elite rhythmic gymnastics athletes with low back pain. Design: Double-blind, randomized, controlled trial. Setting: The sports hall of “Puente Tocinos,” Murcia, Spain. Participants: Ninety gymnastics athletes were randomized into 2 parallel groups (intervention: n = 39; control: n = 51), of whom 98.9% were women (women = 89; man = 1). Intervention: The Mézières method postural therapy was implemented. It lasted about 60 minutes in repeated sessions of 2 to 3 meetings per week by counting in overall 60 sessions during a 24-week period. Main Outcome Measures: Visual analog scale of pain, sit and reach flexibility test, Runtastic (pedometer performance android application), Roland–Morris Questionnaire for the physical disability, and the Health Status Questionnaire were used. Results: The univariate analysis of variance and independent sample t test revealed a significant improvement in the intervention group concerning the visual analog scale pain assessment scale (P < .05, ), and, also, the between-groups effect size was high during the 24 sessions of treatment (d > 0.8) compared with the control one. The same situation persists even for Roland–Morris Questionnaire (P < .05, ), physical score (P < .05, ), mental score (P < .05, ), sit and reach flexibility test (P < .05, ), and Runtastic performance (P < .05, ), where the between-groups effect size was high during the 24 sessions of treatment (d > 0.8). Conclusion: The Mézières method treatment performed on athletes with low back pain has caused positive effects on all the outcomes analyzed compared with the ones of control group.

The effect of nature sounds and earplugs on anxiety in patients following percutaneous coronary intervention: A randomized controlled trial

2019 ◽  
Vol 18 (8) ◽  
pp. 651-657 ◽  
Author(s):  
Kamile Akarsu ◽  
Ayşegül Koç ◽  
Nurcan Ertuğ
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Visual Analog Scale ◽  
State Anxiety ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Control Group ◽  
Percutaneous Coronary Interventions ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Percutaneous Coronary

Background: Percutaneous coronary interventions cause anxiety in patients, although these procedures are lifesaving. Aim: The aim of this study was to determine the effect of nature sounds and earplug interventions on the anxiety of patients after percutaneous coronary interventions. Methods: A randomized controlled trial design was used in this study. A total of 114 patients who were scheduled to undergo percutaneous coronary intervention were allocated to three groups in a randomized manner: two intervention groups (nature sound group, earplug group) and one control group. The Visual Analog Scale, State Anxiety Inventory and physiological parameters were used to measure anxiety. Data were collected from the patients at three time points: immediately before, immediately after and 30 minutes after the interventions. Results: The respiratory rates and the Visual Analog Scale and State Anxiety Inventory scores of patients in the nature sound and earplug groups immediately after and 30 minutes after the interventions were significantly lower than those of the control group ( p < 0.05). No differences were found when comparing respiratory rates, Visual Analog Scale scores and State Anxiety Inventory scores between patients in the nature sound group and patients in the earplug group ( p > 0.05). No changes were observed in the pulse and systolic/diastolic blood pressure values of patients in the control and intervention groups ( p > 0.05). Conclusions: It was determined that nature sounds and earplug interventions are effective in reducing the anxiety of patients following percutaneous coronary intervention.

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