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FDA Approves Personalized Chronic Pain Therapy Mobile Application

A new digital health tool has been approved by the US Food and Drug Administration (FDA).

The approval of the iOS-compatible application will enable individuals with chronic pain and movement disorders to receive personalized therapy through their mobile device.

Abbott can now move forward with the Patient Controller app on a compatible personal Apple smartphone devices and eliminate the need to carry a separate patient programmer device to streamline the therapeutic experience and seamlessly integrate therapy management.

The company plans to integrate the new technology into their broader NeuroSphere Digital Care connected care management platform that was launched in May.

The Patient Controller is compatible with Abbott’s suite of neuromodulation technologies, including Infinity DBS System for patients with Parkinson disease or essential tremor, Proclaim XR SCS System for patients living with chronic pain, and Proclaim DRG Neurostimulation System for patients with chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia.

“For physicians who are prescribing and implanting neuromodulation technologies, the ability to integrate therapies into one's everyday life is key,” Alexander Escobar, M.D., Clinical Assistant Professor of Anesthesiology and Pain Medicine at The University of Toledo, said in a 

. “The COVID-19 global health crisis has demanded access to virtual treatment options, especially for those individuals with chronic medical conditions that may have difficulty coming to see their physician or would prefer not to leave their own home.”

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Patients who use the application will receive personalized therapy through their mobile device.

FDA Approves Digital Health App for Chronic Pain Management

Telemedicine and Face-to-Face CBT Both Effective Treating Insomnia

Telemedicine has emerged as an option in treating insomnia and other sleep issues.

A University of Michigan research team, led by J. Todd Arnedt, PhD, Sleep and Circadian Research Laboratory, Department of Psychiatry, compared face-to-face and telemedicine delivery of cognitive behavioral therapy for insomnia for improving insomnia/sleep and daytime functioning at post-treatment and a three-month follow-up. The findings backed the rise in telemedicine use since the start of the coronavirus disease 2019 (COVID-19) pandemic.

In the randomized, controlled non-inferiority trial, the investigators also compared the modalities on treatment credibility, satisfaction, and therapeutic alliance.

The trial included 65 adults with chronic insomnia, 46 of which were women. Each individual was randomized to receive either 6 sessions of CBT for insomnia delivered individual through AASM SleepTM (n = 33) or face-to-face (n = 32).

Each participant completed a sleep diary, the Insomnia Severity Index (ISI), and daytime functioning measures at pre-treatment, post-treatment, and three-month follow-up.

The investigators compared treatment credibility, satisfaction, and the therapeutic alliance between treatment modalities.

The telemedicine modality was noninferior to the face-to-face option based on a margin of 4 points on the ISI and after adjusting for confounders  (β = 0.54; SE = 1.10; 95% CI, -1.64 to 2.72) and follow-up (β = 0.34; SE = 1.10; 95% CI, -1.83 to 2.53).

Both treatments resulted in improved daytime functioning measures other than the physical composite scale of the SF-12 at post-treatment and follow-up measurements. The telemedicine sessions were also on average about 10 minutes shorter, but participants rating of therapeutic alliance were similar in the 2 therapy groups.

“Telemedicine delivery of CBT for insomnia is not inferior to face-to-face for insomnia severity and yields similar improvements on other sleep and daytime functioning outcomes,” the authors wrote. “Further, telemedicine allows for more efficient treatment delivery while not compromising therapeutic alliance.”

Outside of therapy sessions, individuals with 

 may benefit from a personalized version of therapy administered through their smartphones.

A team, led by Isa Okajima, PhD, Department of Psychological Counseling, Faculty of Humanities, Tokyo Kasei University, explored whether a brief behavioral therapy smartphone application for insomnia could improve insomnia-related symptoms and worker productivity.

According to the stepped-care model, there is a medium to large effect size for using cognitive behavioral therapy for insomnia (BBTI) delivered digitally. However, studies show follow automated cognitive behavioral therapy for insomnia applications without additional expert support have high dropout rates.

When compared to the waiting list control group, both brief behavior therapy for insomnia interventions were more effective for reduction of insomnia severity (tailored BBTI: Hedges 

&thinsp;= &thinsp;—1.64; 95% CI, –2.32 to –0.96; 

&thinsp;= &thinsp;—1.28; 95% CI, –1.93 to –0.63; 

&thinsp; <&thinsp;.001) at the 3-month follow-up.

The tailored therapy quickly reduced insomnia severity (1-month follow-up: 

&thinsp; = &thinsp;—0.85; 95% CI, –1.46 to –0.24) and was only more effective for improvement of work performance (

&thinsp; = &thinsp;—1.09; 95% CI, –1.71 to –0.46; 

&thinsp;= &thinsp;.005), social disabilities related to family life (g&thinsp; = &thinsp;—0.89; 95% CI, –1.51 to –0.28; 

&thinsp;= &thinsp;—1.09; 95% CI, –1.72 to –0.46; 

&thinsp;=&thinsp;.007) compared with the waiting list control group at the 3-month follow-up. 

Telemedicine Versus Face-to-Face Delivery of Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Non-Inferiority Trial

Telemedicine delivery of CBT allows for more efficient treatment delivery for insomnia.

Kenny Walter

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FDA Approves Digital Health App for Chronic Pain Management

Telemedicine Effective in Treating Insomnia