The recently completed Fibromyalgia Activity Study With TENS (FAST) established the efficacy of transcutaneous electrical nerve stimulation (TENS) for the treatment of musculoskeletal pain in patients with fibromyalgia. Physical therapists generally are trained in the use of TENS, but the technique is underused in clinical practice.
The Fibromyalgia TENS in Physical Therapy Study (FM TIPS), a new NIH Collaboratory Demonstration Project, will assess the feasibility of adding TENS to routine physical therapy for patients with fibromyalgia. In addition to evaluating symptom improvement, the study will measure the effect of TENS on adherence to physical therapy, achieving therapeutic goals, and medication use.
At the NIH Collaboratory PRISM kickoff meeting in November, we asked co–principal investigators Dr. Kathleen Sluka and Dr. Leslie Crofford to discuss the rationale for their study and the value of engaging with a network of experts in pragmatic clinical trials.
“Delivering [the intervention] and seeing how difficult it is to use in a clinical practice on a day-to-day basis—and delivering it to any patient who happens to have [the condition]—seems to me to be the best way to find out if it’s really going to work in clinical practice,” explained Dr. Sluka.
Dr. Crofford added, “What we’re aiming to do is to make it easy for the clinician to choose these nonpharmacologic strategies for treatment of pain that improve both symptom and function in patients with fibromyalgia.”
FM TIPS is a project of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.
“The Collaboratory has a wealth of expertise across multiple domains that can help us implement this and give us the knowledge we need in order to make this a successful trial,” said Dr. Sluka.
“We don’t think that anybody’s ever tried to do a pragmatic trial in physical therapy practice. So this is something that we hope that we can share back with the Collaboratory about how do you do this in nontraditional settings for research. We’re hoping to learn, and we hope they learn from us,” said Dr. Crofford.
FM TIPS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The NIH Collaboratory PRISM Resource Coordinating Center is supported by the National Center for Complementary and Integrative Medicine. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.