FM TIPS

March 18, 2021: FM-TIPS Becomes First PRISM NIH Collaboratory Trial to Begin Enrollment

Posted on by Damon Seils
Still image from a video interview of Drs. Kathleen Sluka on the left and Leslie Crofford on the right
Dr. Kathleen Sluka (left) and Dr. Leslie Crofford (right)

The Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) has begun enrollment of study participants. It is the first study supported through the NIH Heal Initiative’s PRISM program to begin enrollment.

Congratulations to co–principal investigators Drs. Kathleen Sluka and Leslie Crofford and the FM-TIPS team!

The PRISM projects—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing—are studying the real-world effectiveness of nonpharmacologic interventions for pain and assessing the implementation of these interventions to improve pain management and reduce reliance on opioids. The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

FM-TIPS is using a cluster randomized trial design to assess the feasibility of using transcutaneous electrical nerve stimulation (TENS) in addition to physical therapy for the treatment of fibromyalgia. The study will also determine whether the use of TENS improves symptoms of fibromyalgia, increases adherence to physical therapy and the likelihood of meeting therapeutic goals, and reduces medication use.

During the 1-year planning phase, the study team recruited physical therapy sites into the trial, established a better understanding of usual practice to inform trial processes, and ensured the adequacy of trial infrastructure. Learn more about FM-TIPS in this interview with Drs. Sluka and Crofford.

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.

February 8, 2021: Meeting Minutes are Available from the Ethics and Regulatory Core Discussions with the PRISM NIH Collaboratory Trials

Posted on by Gina Uhlenbrauck

Meeting minutes, supplementary materials, and updates are available that summarize recent discussions related to the ethics and regulatory issues associated with the six PRISM NIH Collaboratory Trials:

These discussions, which took place by teleconference, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel as well as some IRBs responsible for oversight of the projects.

October 6, 2020: Four PRISM NIH Collaboratory Trials Awarded Continuation From Planning to Implementation Phase

Posted on by Gina Uhlenbrauck

The NIH Collaboratory is pleased to announce that the four PRISM NIH Collaboratory Trials received approval to transition from the planning phase to the implementation phase of their studies. These embedded PCTs (ePCTs) are directly addressing the U.S. opioid crisis and exploring fundamental questions of pain management using nonpharmacologic treatments.

Congratulations to the PIs and study teams for their excellent work!

BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

Karen Sherman, PhD, MPH
Photo of Lynn DeBar, principal investigator of PPACT
Lynn DeBar, PhD, MPH

BackInAction is conducting a three-arm pragmatic trial of older adults who have chronic low back pain to evaluate acupuncture versus usual care. The study will compare a standard 12-week course of acupuncture, an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course), and usual care to assess back-related function at 26 weeks.

 

 

 

 

FM TIPS: Fibromyalgia TENS in Physical Therapy Study

Kathleen Sluka, PT, PhD
Leslie Crofford, MD

The aim of FM TIPS is to demonstrate the feasibility of adding transcutaneous electrical nerve stimulation (TENS) to the treatment of patients with fibromyalgia in a real-world physical therapy setting, and to determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy, and allows patients with fibromyalgia to reach their specific functional goals with less medication use.

 

 

 

NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management

Photo of Andrea Cheville, co–principal investigator of NOHARM
Andrea Cheville, MD
Jon Tilburt, MD

NOHARM is a stepped-wedge cluster-randomized trial that is testing a sustainable system-wide strategy for perioperative pain management using nonpharmacologic options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort.

 

 

 

 

OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting

Natalia Morone, MD

OPTIMUM aims to evaluate the impact of an innovative, group-based mindfulness program for patients with chronic low back pain in a real-life clinical setting. Mindfulness is effective for the treatment of chronic low back pain, yet remains underutilized as it has not been regularly woven into the outpatient clinical setting.

 

 

 

 

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center and is supported by the National Center for Complementary and Integrative Health. 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.

July 24, 2020: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (Leslie J. Crofford, MD; Kathleen Sluka, PT, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center

Kathleen Sluka, PT, PhD
Kate Daum Research Professor
Department of Physical Therapy and Rehabilitation Science
University of Iowa

Topic

TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

Keywords

Fibromyalgia; Musculoskeletal pain; Neuropathic pain; Transcutaneous electrical nerve stimulation (TENS); Physical therapy; Nonpharmacologic pain treatment; PRISM; Patient-reported outcomes (PROs)

Key Points

  • Fibromyalgia (FM) is a condition of widespread pain that is worsened with physical activity. It involves chronic musculoskeletal and visceral pain and is often accompanied by fatigue, depression, or anxiety.
  • Transcutaneous electrical nerve stimulation (TENS) is a technique that uses a device to deliver an electric impulse through the skin. Treatment with TENS has been shown to improve resting and movement-evoked pain and fatigue.
  • While physical therapists generally are trained in the use of TENS, the technique remains underused in clinical practice.
  • The goal of the FM TIPS pragmatic trial is to determine, in a real-world clinical setting, whether physical therapy combined with TENS for patients with FM is more effective than physical therapy alone. The study is being piloted in 24 sites across 5 physical therapy health systems.

Discussion Themes

While COVID-19 has had an impact on piloting the FM TIPS study, some kind of physical therapy will be possible through telemedicine. Other challenges include that conducting embedded research in physical therapy clinics is new, and there are multiple different EHR systems in use across the partnering clinics.

The recently published results from Fibromyalgia Activity Study With TENS (FAST) showed that TENS can be safely used in addition to other treatments to improve pain and fatigue in women with fibromyalgia in the setting of a randomized controlled trial.

Read more about the Fibromyalgia TENS in Physical Therapy Study (FM TIPS) NIH Collaboratory Trial and watch a brief interview with the PIs of the study.

FM TIPS is one of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) studies.

Tags

#pctGR, @Collaboratory1

June 4, 2020: New Chapter in the Living Textbook Describes the Uses and How-tos of Patient-Reported Outcomes

Posted on by Karen Staman

A new chapter in the Living Textbook describes how patient-reported outcomes (PROs) are used in different settings and how to choose and integrate PRO measures into an embedded pragmatic clinical trial.

The chapter also characterizes PRO use within the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) of the NIH HEAL Initiative (Helping End Addiction Long-term Initiative). NIH Collaboratory Trials supported through the PRISM program include:

AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
FM TIPS: Fibromyalgia TENS in Physical Therapy Study
NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

The main topics of the chapter are:

The authors also include Core Outcome Sets for chronic pain, low back pain, musculoskeletal pain, and cancer.

March 4, 2020: FM TIPS Explores Novel Fibromyalgia Treatment in Physical Therapy Practices: An Interview With Dr. Kathleen Sluka and Dr. Leslie Crofford

Posted on by Damon Seils

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.

November 2019 Onboarding Meeting: NOHARM, OPTIMUM, FM TIPS, and AcuOA

PRISM Onboarding Meeting

November 19-20, 2019
Bethesda, MD

Main Purpose

To welcome the PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and
an understanding of the Core Working Groups; and discuss lessons learned from the Collaboratory.

Tuesday, November 19, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Introduction of the New Study Teams, NIH Program Staff, and Coordinating Center Core Work
Groups
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of the NIH HCS Research Collaboratory Program
Cathy Meyers, MD

HEAL Initiative Overview
Rebecca Baker, PhD

Overview of a HEAL Cooperative Agreement
Wendy Weber, ND, PhD, MPH; Laura Wandner, PhD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

CMS and the NIH Collaboratory
Joseph Chin, MD, MS

ClinicalTrials.gov Registration and Reporting
Stacey Arnold, PhD

Discussion From New UG3 NIH Collaboratory Trials

  • NOHARM
    Andrea Cheville, MD; Jon Tilburt, MD
  • FM TIPS
    Kathleen Sluka, PT, PhD; Leslie Crofford, MD
  • AcuOA
    Lynn DeBar, PhD, MPH; Karen J Sherman, PhD, MPH

Lessons Learned from Seasoned NIH Collaboratory Trials
Lesley Curtis, PhD; Ted Melnick, MD, MHS; Jerry Jarvik, MD, MPH; Vincent Mor, PhD; Doug Zatzick, MD; Miguel Vazquez, MD

Closing Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

 

Wednesday, November 20, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Breakout Sessions

Debrief for Breakout Sessions
Adrian Hernandez, MD, MHS; Patrick Heagerty, PhD; Leah Tuzzio, MPH; Rachel Richesson, PhD, MPH; Kevin Weinfurt, PhD; Lesley Curtis, PhD

Closing Remarks/Adjourn
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

November 26, 2019: PRISM Kickoff Meeting Welcomes New NIH Collaboratory Trials to NIH Collaboratory

Posted on by Damon Seils

The NIH Collaboratory welcomed 4 new NIH Collaboratory Trial teams last week during a kickoff meeting in Bethesda, Maryland. These pragmatic clinical trials embedded in healthcare systems are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative to address the opioid crisis.

PRISM NIH Collaboratory Trial Investigators
Left to right: Kathleen Sluka, PT, PhD (FM TIPS); Andrea Cheville, MD (NOHARM); Karen Sherman, PhD, MPH (AcuOA); Jon Tilburt, MD (NOHARM); Lynn DeBar, PhD, MPH (AcuOA); Leslie Crofford, MD (FM TIPS); and Natalia Morone, MD (OPTIMUM).

In its recently announced role as the PRISM Resource Coordinating Center, the NIH Collaboratory Coordinating Center will provide technical support and pragmatic trial expertise for the new NIH Collaboratory Trials. The projects address a range of questions related to pain management and opioid prescribing. They include:

  • AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
  • OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting

Attendees of the PRISM kickoff meeting included the NIH Collaboratory Trial teams, NIH Collaboratory leadership and Coordinating Center faculty and staff, and representatives of several NIH Institutes, Centers, and Offices. The NIH Collaboratory Trial teams presented their studies to the full group for discussion. They then participated in individual breakout sessions with the Core Working Groups to discuss anticipated challenges in design, implementation, analysis, and dissemination.