scholarly journals Improved User Engagement and Assessment of Treatment Effectiveness in Patients Utilizing a Novel Digital Mobile Health Application During Spinal Cord Stimulation Screening Trials (Preprint)

2021 ◽  
Author(s):  
Jennifer M. Lee ◽  
Rex Woon ◽  
Mandy Ramsum ◽  
Daniel Steven Halperin ◽  
Roshini Jain
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Success Rate ◽  
Real Time ◽  
Real World ◽  
Spinal Cord Stimulation ◽  
Activity Level ◽  
User Engagement ◽  
Health Related ◽  
Screening Trial

BACKGROUND Patient outcomes and experience during a Spinal Cord Stimulation (SCS) screening trial can have a significant effect on whether or not to proceed with long-term, permanent implantation of an SCS device for treatment of chronic pain. Enhancing the ability to track and assess patients during this initial trial evaluation offers the potential for improved understanding regarding the suitability of permanent device implantation as well as identification of the particular SCS-based neurostimulative modalities and/or parameters that may provide substantial analgesia in a patient-specific manner. OBJECTIVE In this report, we describe a preliminary, real-world assessment of a new, real-time tracking, smart device-based digital application (app) used by patients with chronic pain undergoing trial screening for SCS therapy. METHODS This is a real-world, retrospective evaluation of 13,331 patients diagnosed with chronic pain who utilized the new “mySCS” mobile application (Boston Scientific, Valencia, CA) during an SCS screening trial. The app design is HIPAA-compliant and compatible with most commercially available smartphones (e.g., Apple ® iPhone ®, Android ®). The app enables tracking of user-inputted health-related responses (i.e., pain relief, activity level, and/or sleep quality) in addition to personal trial goals and a summary of overall experience during the SCS trial. A de-identified, aggregate analysis of user engagement, user-submitted responses, and overall trial success was conducted. RESULTS When provided the opportunity, the percentage of users who engaged with the tracking app for ≥50% of the time during their trial was found to be 64.5%. Among those who used the app, ~58% (n = 7795) entered a trial goal(s). Most patients underwent SCS screening with a trial duration of at least 7-days (n = 7739). Of those patients who undertook a 7-day SCS trial, 62.3% engaged the app for 4-days or more. In addition, among all who submitted descriptive responses using the app, health-related improvements were reported by 78% of patients who reached day 3 of the screening phase assessment and by 83% of those who reached trial completion. A trial success rate of 91% was determined for those who used the app (versus 85% success rate for non-users). CONCLUSIONS Data from this initial, real-world examination of a mobile, digital-health-based tracking application (“mySCS” app), as utilized during the SCS screening phase, demonstrates that substantial patient engagement can be achieved while also providing for the acquisition of more real-time and direct from patient outcome measures that may help facilitate improved SCS trial success.

scholarly journals Correction to: Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sam Eldabe ◽  
Ashish Gulve ◽  
Simon Thomson ◽  
Ganesan Baranidharan ◽  
Rui Duarte ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Spinal Cord Stimulation ◽  
Clinical Utility ◽  
Controlled Trial ◽  
Effectiveness Trial ◽  
Randomised Controlled ◽  
Screening Trial

Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to be corrected as follows:

scholarly journals Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies

Biomedicines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 180
Author(s):  
Ganesan Baranidharan ◽  
Deborah Edgar ◽  
Beatrice Bretherton ◽  
Tracey Crowther ◽  
Abdul-Ghaaliq Lalkhen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Real World ◽  
Spinal Cord Stimulation ◽  
Retrospective Studies ◽  
Incidence Rates ◽  
Efficacy And Safety

10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza® 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6–34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67–100% at ≤12 months follow-up, and from 46–76% thereafter. 32–71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.

Retrospective analysis on the effect of spinal cord stimulation on opioid consumption

2020 ◽  
Author(s):  
Awinita Barpujari ◽  
Michael A Erdek
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Retrospective Analysis ◽  
Spinal Cord Stimulation ◽  
Alternative Therapy ◽  
Opioid Consumption ◽  
Opioid Use ◽  
Number Of Patients ◽  
Chronic Pain Conditions ◽  
Post Trial

Aim: Spinal cord stimulation (SCS) is used to clinically manage and/or treat several chronic pain etiologies. A limited amount is known about the influence on patients' use of opioid pain medication. This retrospective analysis evaluated SCS effect on opioid consumption in patients presenting with chronic pain conditions. Materials & methods: Sixty-seven patients underwent a temporary trial device, permanent implant or both. Patients were divided for assessment based on the nature of their procedure(s). Primary outcome was change in morphine equivalent dose (MED), ascertained from preoperative and postoperative medication reports. Results: Postoperative MED was significantly lower in patients who received some form of neuromodulation therapy. Pretrial patients reported an average MED of 41.01 ± 10.23 mg per day while post-trial patients reported an average of 13.30 ± 5.34 mg per day (p < 0.001). Pre-implant patients reported an average MED of 39.14 ± 13.52 mg per day while post-implant patients reported an average MED of 20.23 ± 9.01 mg per day (p < 0.001). There were no significant differences between pre-trial and pre-implant MED, nor between post-trial and post-implant MED. Of the 42 study subjects who reported some amount of pre-intervention opioid use, 78.57% indicated a lower MED (n = 33; p < 0.001), 16.67% indicated no change (n = 7) and 4.76% (n = 2) indicated a higher MED, following intervention. Moreover, SCS therapy resulted in a 26.83% reduction (p < 0.001) in the number of patients with MED >50 mg per day. Conclusion: Spinal cord stimulation may reduce opioid use when implemented appropriately. Neuromodulation may represent alternative therapy for alleviating chronic pain which may avoid a number of deleterious side effects commonly associated with opioid consumption.

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