FM TIPS

April 2, 2026: In FM-TIPS Pragmatic Trial, Adding TENS to Physical Therapy Improved Fibromyalgia Pain

Posted on by Damon Seils

Headshots of Dr. Kathleen Sluka and Dr. Leslie Crofford
Dr. Kathleen Sluka and Dr. Leslie Crofford, principal investigators for FM-TIPS

Adding transcutaneous electrical nerve stimulation (TENS) to physical therapy reduced pain for patients with fibromyalgia, according to the FM-TIPS pragmatic clinical trial.

The results of the study were published online in JAMA Network Open.

FM-TIPS, an NIH Collaboratory Trial, examined whether the addition of TENS to routine outpatient physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. TENS is a noninvasive, nondrug therapy that delivers low-voltage electrical currents through electrodes placed on the skin.

The study was led by principal investigators Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.

"TENS is a safe, effective treatment for movement-evoked pain and fatigue in individuals with fibromyalgia," Sluka said."It is an inexpensive and readily available treatment that individuals can use at home to help manage their pain," she added.

The study team randomly assigned 28 outpatient physical therapy clinics in 6 healthcare systems to provide either physical therapy plus TENS or physical therapy alone to patients enrolled in the study. Across the participating clinics, 384 patients completed baseline data collection from February 2021 through September 2024 and completed final data collection by March 2025. Patients in the TENS group were instructed to apply the electrodes to the upper and lower back and wear them for 2 hours per day with a minimum of 30 minutes per session.

FM-TIPS logoAfter 60 days, movement-evoked pain was significantly lower among patients receiving physical therapy plus TENS compared with patients receiving physical therapy alone. In an extension of the study from day 60 to day 180, patients in the physical therapy only group began receiving TENS and patients in the TENS group continued with the treatment. At 180 days, 81% of patients reported finding TENS to be helpful and 55% were still using it daily.

Read the full article.

"The NIH Collaboratory was essential in helping the study team to design and execute FM-TIPS; we could not have done it without their continued consultation and support," Sluka said.

FM-TIPS is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about FM-TIPS.

December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup"In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Core Working Groups

Biostatistics and Study Design Core

Community Health Improvement Core

Electronic Health Records Core

Ethics and Regulatory Core

Health Care Systems Interactions Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

ACP PEACE

ARBOR-Telehealth

BackInAction

BeatPain Utah

BEST-ICU

EMBED

FM-TIPS

GGC4H

GRACE

HiLo

I CAN DO Surgical ACP

IMPACt-LBP

INSPIRE

iPATH

LIRE

MOMs Chat & Care Study

NOHARM

Nudge

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

December 3, 2025: Results From the FM-TIPS Trial, in This Week’s Rethinking Clinical Trials Grand Rounds

Posted on by Sophia Ramirez

In this Friday’s Rethinking Clinical Trials Grand Rounds, Leslie J. Crofford, Dana Dailey, and Kathleen Sluka will present “Transcutaneous Electrical Nerve Stimulation Reduces Movement-Pain in People With Fibromyalgia: Results From FM-TIPS, a Cluster Randomized Pragmatic Trial.”

The Grand Rounds session will be held on Friday, December 5, 2025, at 1:00 pm eastern.

FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. The trial is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

Crofford is the Wilson Family Chair in Medicine and a Professor of Medicine and Pathology, Microbiology & Immunology at the Vanderbilt University Medical Center. Dailey is an assistant research scientist at the University of Iowa. Sluka is a professor at the University of Iowa.

Join the online meeting.

December 2, 2025: Community Engagement Strategies Boost Rural Enrollment in FM-TIPS Fibromyalgia Trial

Posted on by Damon Seils

FM-TIPS logoNew findings from FM-TIPS show that targeted community engagement methods are highly effective in increasing recruitment and enrollment, particularly among rural participants who are typically underrepresented in clinical research.

The report was published online in the Journal of Clinical and Translational Science.

FM-TIPS, an NIH Collaboratory Trial, is a cluster randomized trial examining whether adding transcutaneous electrical nerve stimulation to routine physical therapy improves outcomes for patients with fibromyalgia receiving care in physical therapy clinics. Recruitment for clinical trials often faces barriers in rural communities, which make up 19% of the US population but experience a significant burden of chronic pain, including fibromyalgia.

To address projected low enrollment rates in certain locations, the FM-TIPS study team implemented specific community engagement strategies partway through the trial for 2 groups: targeted rural clinics and targeted low-enrollment clinics. They compared these groups to a group of untargeted clinics.

The initiative was guided by 2 full-time community engagement coordinators who tailored a multipronged approach for each local community. Strategies included posting individualized flyers in public spaces, conducting physician outreach, and using social media ads and direct mail campaigns. Key to the initiative’s success was establishing strong partnerships with local physical therapy clinics and their staff, who served as trusted community members.

Implementation of these strategies resulted in a significant increase in study inquiries, screening, and enrollment. Average monthly inquiries across all clinics rose from 2 per month to 28, a 760% increase over projected numbers. The most effective strategies for generating inquiries were social media ads and direct mail.

When comparing actual enrollment to projected enrollment, the community engagement efforts boosted enrollment by 23% in the targeted rural clinics and 107% in the targeted low-enrollment clinics. There was no significant increase in enrollment in the untargeted group.

The strategies also successfully increased the enrollment of rural residents. Notably, 99% of rural residents who passed screening went on to enroll in the study, compared to only 32% of urban residents who passed screening—highlighting the rural participants’ high willingness to join the research once barriers were addressed.

“These findings contribute to a growing body of research demonstrating that pragmatic trials, when combined with strong community engagement, can help bridge healthcare disparities in rural populations,” the authors wrote.

Read the full report.

FM-TIPS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

July 14, 2025: Researchers Share Tips for Building Relationships With Communities in Pragmatic Research

Posted on by Elizabeth Mccamic

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research.

The panelists included Jennifer Kawi, principal investigator (PI) for APA-SM; Kathleen Sluka, PI for FM-TIPS; Sebastian Tong, PI for AIM-CP; and David Wetter, PI for LungSMART. They shared examples of how community relationships have enriched their trials, along with impediments to meaningful community engagement and successful methods for building relationships with communities.

Key Strategies for Engaging With Communities

  • Build long-standing relationships with community partners, develop shared goals, and practice shared decision-making.
  • Design for sustainability. Design research projects with minimal disruption to the clinical workflow; utilize existing community health workers and programs; and integrate behavioral economics principles (nudges) into study design.
  • Budget for community engagement and include community members in study planning from the beginning.
  • Engage in the preferred language of the community. Ensure there are research staff who are fluent in the community’s preferred language and embedded in the community so they can provide key perspectives and help build trust.
  • Provide community health workers and research staff with training on community engagement.
  • Connect with community members where they spend time, such as community events and fairs, and visit local clinics to share information for referrals.

About the Trials

  • AIM-CP, supported by the National Institute of Nursing Research, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.
  • APA-SM, supported by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, is testing a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas.
  • FM-TIPS, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia.
  • LungSMART, supported by the National Cancer Institute, is testing telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

January 8, 2025: In This Week’s PCT Grand Rounds, Community Engagement Methods in the FM-TIPS Trial

Posted on by Damon Seils

Headshots of Dr. Heather Schacht Reisinger and Dr. Dana DaileyIn this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.”

The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern.

FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. The trial is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

Reisinger is an associate professor of internal medicine and the associate director of engagement, integration, and implementation in the Institute for Clinical and Translational Science; and Dailey is an assistant research scientist in the Department of Physical Therapy and Rehabilitation Science—both in the University of Iowa’s Carver College of Medicine.

Join the online meeting.

December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A graphic showing a collection of journal covers.In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program surpassed 340.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Core Working Groups

Biostatistics and Study Design Core

Electronic Health Records Core

Ethics and Regulatory Core

Community Health Improvement Core

Implementation Science Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

BackInAction

BeatPain Utah

EMBED

FM-TIPS

GGC4H

GRACE

I CAN DO Surgical ACP

ICD-Pieces

LIRE

NOHARM

Nudge

OPTIMUM

PRIM-ER

PROVEN

SPOT

STOP CRC

TSOS

October 15, 2024: Case Study Describes a Reassessment of Sample Size in an Ongoing Cluster Randomized Trial

Posted on by Damon Seils

FM-TIPS logoA new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials.

Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size. Often they use preliminary data from the planned enrollment sites to estimate the correlation. However, when preliminary data are unavailable at the time of study design, they may use interim data collected during the trial itself to reassess the trial’s sample size.

The contributors of the case study focus on FM-TIPS, an NIH Collaboratory Trial, to describe an approach to conducting an interim reassessment of sample size in an ongoing trial. Read the full case study.

FM-TIPS is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. The trial is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

The contributors of the case study include members of the FM-TIPS study team and leaders of the NIH Collaboratory’s Biostatistics and Study Design Core. David-Erick Lafontant is a statistician, Bridget Zimmerman is a clinical professor of biostatistics, and Emine Bayman is an associate professor of biostatistics—all at the University of Iowa. Megan McCabe is an assistant professor of biostatistics at the University of Alabama at Birmingham. Patrick Heagerty is a professor of biostatistics at the University of Washington. Liz Turner is an associate professor of biostatistics and bioinformatics at Duke University.

Grand Rounds Ethics and Regulatory Series October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Tanya Matthews, PhD; Leslie J. Crofford, MD)

Posted on by Elizabeth Mccamic

Speakers

Joseph Ali, JD
Assistant Professor, Dept. of International Health
Johns Hopkins Bloomberg School of Public Health
Core Faculty & Associate Director for Global Programs
Johns Hopkins Berman Institute of Bioethics

Tanya Matthews, PhD
HRPP Director
Kaiser Permanente Washington

Leslie J. Crofford, MD
Wilson Family Chair in Medicine
Professor of Medicine and Pathology, Microbiology & Immunology
Chief, Division of Rheumatology
Vanderbilt University Medical Center

 

 

Keywords

Ethics, IRB, FM-TIPS

 

Key Points

  • Trials are getting larger and collecting greater volumes of clinical data than ever before, often as part of Common Data Elements (CDEs). These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. substance use, depression, anxiety, suicidality). This raises a lot of questions: Whose responsibility is it to monitor those risk factors? What should be monitored and how? Who can and should act/respond? What do patients and other stakeholders desire?
  • There are additional complexities with pragmatic clinical trials (PCTs), including overlapping roles and responsibilities of clinical and research staff; collection of broad sets of CDEs can make data monitoring more challenging; various and combined methods for data collection (e.g. extraction from health records and/or have treating clinicians or patients complete measures); and trials may operate under waivers of consent. There is a possible for risk-signaling data to “slip between the cracks.”
  • When trials collect risk-signaling data related to study outcomes, researchers and other stakeholders should understand and align stakeholder expectations; consider characteristics of the trial and study population to inform response; define triggers, thresholds, and responsibilities for action; identify appropriate response mechanisms and capabilities; integrate responses with clinical practices and systems; and address privacy demands. No single factor is more important than another.
  • Case Study: The Fibromyalgia Tens In Physical Therapy (FM-TIPS) trial was designed to demonstrate the feasibility of adding TENS to treatment of patients with FM in a real-world PT practice setting and determine if addition of TENS to standard PT for FM reduces pain, increases adherence to PT and allows patients with FM to reach their specific functional goals with less drug use.
  • FM-TIPS prospectively defined possible ethical concerns for the trial including concerns around mental health and substance use disorders, that led the study team to add language to the consent document about unexpected findings and the team decided to conduct monthly monitoring of data to identify any signals but to otherwise rely on clinicians to manage issues as is standard in PT practice.
  • Due to the low referral rates of fibromyalgia patents to PT (~30%), FM-TIPS had an emergent ethic issue related to patient recruitment and whether the study team could include the American College of Rheumatology criteria to screening to increase eligibility. In the end, the study team determined that making a new diagnosis unknown to the participant was beyond the scope of a PCT in a PT setting.

Learn more about FM-TIPS.

Discussion Themes

-Does it matter if the trial is being done at an integrated delivery system and a more traditional? There is a different level of decision making between the two cases Leslie described in the FM-TIPs trial. Setting is king when you are making some of these decisions; some settings are more academic and are used to these trials. Others are not used to doing trials. The setting really does matter, and it is a different way of thinking about the research enterprise.

–Actionable to whom by whom is a good question. Another way to think about this topic is when should or should not a trial take on a clinical role? In the FM-TIPS example, there was one case where the data collected by the trial team would also be collected by the clinical team. The timeliness of the response is also important; if the trial is monitoring something they need to be able to respond timely. In the second example, they were not able to. The context of the trial matters a lot in addition to actionability.

Tags

#pctGR, @Collaboratory1

May 24, 2022: FM-TIPS Seeks More Treatment Options for Patients With Fibromyalgia

Posted on by terren.green@duke.edu

FM-TIPS, an NIH Collaboratory Trial, is studying real-world implementation of transcutaneous electrical nerve stimulation (TENS) therapy along with physical therapy to treat patients with fibromyalgia. Dr. Kathleen Sluka, Co-PI of the FM-TIPS project, and Dr. Emine Bayman, biostatistician for the project, discussed the study in an interview after the NIH Collaboratory’s annual steering committee meeting.

 

 

Sluka was excited to share an update on the project. “We are currently enrolling in the study thanks to a fantastic team,” she said. “The team has worked really hard to keep the participating clinics engaged.” With 6 healthcare systems and 30 active centers, the project has enrolled 115 patients.

The study faced several challenges during the startup phase, the biggest of which was the COVID-19 pandemic. Some of the smaller clinics participating in the study don’t have the staffing capacity to remain open when staff contract COVID-19. “When this happened,” said Sluka, “we did have significant reductions in recruitment.”

The electronic health record (EHR) has also presented challenges for the study. “Each of our healthcare systems is using different EHR systems,” said Bayman. In many clinics, the clinician or physical therapist is responsible for inputting data into the EHR. For busy healthcare staff who may not have training in the EHR system, this extra task can be difficult. The FM-TIPS project found creative ways around this challenge. Bayman said, “One of our most important exploratory outcomes was turned into a patient reported outcome. We will be collecting this data from the patients.”

Despite these challenges, FM-TIPS is making progress toward its goals and hopes to give patients with fibromyalgia more options to manage their pain on a day-to-day basis.

View the full video.

FM-TIPS is supported by the NIH through the NIH HEAL Initiative under an award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.