PainRelief.com Interview with:
Mike Rosenbluth, PhD
CEO, Swing Therapeutics
UCSF Rosenman Innovators Program
San Francisco, CA

PainRelief.com: What is the background for this study?

Response: Fibromyalgia is a chronic pain condition that affects an estimated 10 million Americans, characterized by widespread pain and other physical and cognitive symptoms that include fatigue, disrupted sleep, reduced physical function, memory problems and difficulty concentrating (“brain fog”). Clinical guidelines recommend multimodal treatment that combines medication management with non-drug approaches including cognitive behavioral therapy (CBT), but only 5% of fibromyalgia patients annually end up receiving some form of CBT due to lack of trained providers or cost. 

There have been dozens of studies on CBT for management of chronic pain or fibromyalgia specifically. The majority of these studies are small, are testing an intervention that cannot scale, and are run at a single site. These studies ultimately conclude that more research should be done. We aimed to develop a product that could deliver behavioral therapy for fibromyalgia at scale and test that product in a rigorous study that was powered to demonstrate definitive clinical benefit of the treatment.

Stanza is a self-guided, smartphone-based digital therapy that delivers acceptance and commitment therapy (ACT), a type of CBT.  In this multi-center, randomized controlled trial, 275 participants were randomized to receive either Stanza treatment or an active control intervention (in this case a digital symptom tracker and access to health education). 

PainRelief.com: What are the main findings?

Response: We found that after 12 weeks, 70.6% of participants in the Stanza arm reported an improvement in well-being (measured by Patient Global Impression of Change). The study also clinically validated other Stanza benefits, including improvement in fibromyalgia severity (measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)), and major fibromyalgia symptoms including pain intensity, pain interference, fatigue, sleep disturbance, depression and physical function. No treatment-related adverse events were observed.

PainRelief.com: What should readers take away from your report?

Response: In a world where fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and that can come with difficult to manage side effects, Stanza offers a clinically-validated way to expand access to non-drug, guideline-directed treatments. For millions of people with fibromyalgia, this is a safe and effective complement to traditional pharmacological therapies. This study was used as a basis for FDA clearance of Stanza.

PainRelief.com: What recommendations do you have for future research as a result of this study?

Response: We’re continuing to measure real world outcomes of Stanza as part of comprehensive, multimodal fibromyalgia treatment. Swing developed Swing Care, a specialty virtual care platform for delivering this type of treatment. Early results from Swing Care presented at the Society of Behavioral Medicine in January 2024 support meaningful improvement among patients who receive multimodal care for fibromyalgia, inclusive of Stanza. 81% reported improvement in well-being, as measured by Patient Global Impression of Change (PGIC) at 90 days.

We’re also continuing to study the long-term durability of Stanza. Results from an extension of a prospective single-arm clinical trial (REACT-FM), were presented at the U.S. Association for the U.S. Association for the Study of Pain Annual Meeting in 2023, which found durable clinical effectiveness of the treatment, evidenced by the maintenance of the immediate treatment effect at Month 3 through to Month 12.

Disclosures: This study was sponsored by Swing Therapeutics, the manufacturer of Stanza. Stanza is available by prescription through Swing Care, a specialty clinic that offers comprehensive treatment for fibromyalgia. To learn more about Swing Care, visit swing.care

Citation: R Michael Gendreau, Lance M McCracken, David A Williams, Juan V Luciano, Yifei Dai, Nicolette Vega, Zunera Ghalib, Kristen Guthrie, Allison C Kraus, Michael J Rosenbluth, Ben Vaughn, Jennifer M Zomnir, Dana Reddy, Andrea L Chadwick, Daniel J Clauw, Lesley M Arnold. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. The Lancet, 2024; DOI: 10.1016/S0140-6736(24)00909-7

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Last Updated on July 16, 2024 by PainRelief.com