Study: Smartphone Therapeutic Helps Improve Fibromyalgia in Patients

Swing Therapeutics is touting encouraging early results from a single-arm study (REACT-FM) of its digital fibromyalgia therapeutic. 
 
Swing Therapeutics has developed Stanza, a prescription smartphone-based digital therapeutic for fibromyalgia management. The core of the treatment is acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy (CBT) with proven efficacy in treating fibromyalgia. Stanza is designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness. It was made available to patients in September 2022 under the U.S. Food and Drug Administration’s (FDA) Digital Health Enforcement Policy for Digital Health Devices, and is available by prescription via a healthcare provider.

Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management in a Decentralized Trial
In this study, participants were primarily evaluated using the Patient Global Impression of Change (PGIC) Scale. Other outcomes collected include the Revised Fibromyalgia Impact Questionnaire (FIQ-R), as well as instruments that measure pain intensity and interference, sleep interference, depression, anxiety, pain acceptance, mindfulness, and quality of life (QoL). Outcomes were measured after 12 weeks of using the app, and then analyzed against baseline scores for all completed participants. At the end of a 12-week course of therapy, fibromyalgia patients achieved improvement in all areas measured. Eighty-four percent of participants reported improvement in their fibromyalgia condition after Stanza treatment, with 47% reporting to be “much” or “very much” improved.
 
“People with fibromyalgia have no cure for their condition, and often have trouble managing symptoms, including pain, brain fog, sleep disturbances and anxiety and depression,” said Yifei Dai, Ph.D., head of Clinical and Scientific Affairs at Swing Therapeutics. “I’m encouraged by the results we saw from patients throughout the study and look forward to gathering additional evidence.”

Usability and Acceptability of a Digital Behavioral Therapy for the Management of Fibromyalgia
Swing Therapeutics also reported results of usability research on Stanza that was conducted as part of the REACT-FM trial. In this study, participants evaluated Stanza’s ease of use, interface, and overall satisfaction via the mHealth App Usability Questionnaire (MAUQ) at the end of the 12-week treatment. Treatment preference for the digital therapeutic application versus medication management was evaluated for participants who currently or previously used FDA-approved pharmacological treatments for fibromyalgia.
 
At the end of the 12-week program, 84% and 88% of participants reported positive ratings in the MAUQ domains of “Ease of Use” and “Interface and Satisfaction,” respectively. Approximately 90% of participants who had used FDA-approved fibromyalgia medications preferred treatment with Stanza, or Stanza combined with approved fibromyalgia medication, versus treatment with approved medication alone.
 
“Other self-guided digital behavioral therapies on the market have been created to address accessibility and scalability issues, but many have low engagement due to poor usability,” said Nelson Mitchell, head of Product at Swing Therapeutics. “We’re encouraged by the positive results from this study that support our therapy’s usability and satisfaction for fibromyalgia management.”
 
“This real-world data expands the growing body of clinical evidence supporting the use of digital therapeutics for the management of fibromyalgia, and reinforces the positive outcomes observed from a previous randomized controlled trial,” said Mike Rosenbluth, Ph.D., founder and CEO of Swing Therapeutics. “As we gather additional compelling evidence, our mission is to make digital behavioral therapeutics like Stanza become more accessible to people with fibromyalgia. The launch of Swing Care is an exciting step toward broadening the reach of telemedicine and digital health to a wider population of patients.”
 
Swing Care, an online clinic focused specifically on the treatment of fibromyalgia, launched in Texas in 2022 to focus on holistic treatment for fibromyalgia patients, and includes digital therapeutics as a care option.
 
“People living with fibromyalgia often fall through the cracks of healthcare, and better solutions are needed to improve the quality of their lives. This clinical data demonstrates the power of digital behavioral therapeutics to make a meaningful difference. Swing Care has partnered with Swing Therapeutics to expand access through telehealth to specialized, clinically proven fibromyalgia treatment that otherwise has only been available from a limited number of providers,” said Andrea Chadwick, M.D., a globally recognized expert on the treatment of fibromyalgia and Medical Director of Swing Care. “With Swing Care, patients will receive personalized treatment plans that meet their unique needs, including access to behavioral therapies like Stanza and medication management as needed.”
 
Fibromyalgia is a chronic and debilitating pain condition that affects an estimated 10 million Americans. The condition is 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”), and is often accompanied by anxiety and depression. Because fibromyalgia manifests differently across the affected patient population and can be masked by other accompanying conditions, it is difficult to diagnose and treat.
 
Swing Therapeutics was founded in 2019 to develop digital treatments and services in disease areas where patients are not well-served, and where digital interventions may be effective. Its focus is on tackling autoimmune conditions and chronic overlapping pain conditions (COPCs) like fibromyalgia where central pain sensitization is a significant factor. The company is investing in research to support the development of prescription-based digital therapies and services. Swing Therapeutics received FDA Breakthrough Device Designation for its digital therapy for fibromyalgia management. Its near-term goal is to validate its digital therapy and bring it to market as an FDA-cleared, prescription digital therapeutic. 
 
Swing Care was founded in 2022 to increase access to evidenced-based, holistic treatment for patients living with fibromyalgia. The virtual clinic is focused specifically on the treatment of fibromyalgia and launched with licensed providers in Texas.