Grand Rounds September 6, 2024: Conventional, Complementary, and Integrative Pain Therapies in a Military Population with Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design (Ardith Z. Doorenbos, PhD, RN; Diane M. Flynn, MD, MPH)

Speakers

Ardith Z. Doorenbos, PhD, RN
Professor
Department of Biobehavioral Nursing Science
College of Nursing
University of Illinois, Chicago

Diane M. Flynn, MD, MPH
Primary Care Pain Management Advisor
Interdisciplinary Pain Management Center
Madigan Army Medical Center
Tacoma, WA

Keywords

Chronic Pain; Military; Rehabilitative Care; Pain Therapies; SMART Design

Key Points

  • Physical and occupational therapies are standard rehabilitative care (SRC) for chronic pain, and a growing body of evidence supports complementary and integrative health (CIH) therapies (such as acupuncture, chiropractic, yoga and massage).
  • Few studies have explored the optimal duration, sequence and combination of SRC and CIH to manage chronic pain.
  • The study team investigated the effectiveness of starting treatment for pain with SRC versus CIH therapies. Their primary outcome was the Pain Impact Scores of active-duty service members with chronic pain.
  • Their study design, a Sequential Multiple Assignment Randomized Trial (SMART) Design, randomized participants to CIH or SRC for three weeks each. At that point, participants who were improving continued on in their assigned treatment arm, while those who were not improving were randomized to either the other treatment arm or a combination arm.
  • Compared to baseline pain levels, both groups improved significantly up to six months out. After three weeks, the group that received SRT showed less improvement the group that received CIH therapies. However, by the end of the six-week mark, as well as at three- and six-month follow-ups, there wasn’t a significant difference in average improvement.
  • The study team’s ability to make assessments with regard to the duration of treatment is limited; participants were given the option to continue therapy for up to six weeks, so some were engaged in active therapy during the follow-up period.
  • These findings lend support to expanding access to CIH approaches. Clinicians can feel confident recommending patients start with CIH therapies if that is the patients’ preference.

Discussion Themes

Patients in the CIH arm and SRT arm received therapy for a total of 6.5 and 3 hours per week, respectively. At first blush, this indicates that a treatment hours effect could have contributed to the benefits seen in the first three weeks of the CIH arm; in practice, due to lower-than-intended participation, the actual treatment hours were only slightly higher in the CIH arm than the SRT arm.

Whether it’s caused by pain, combat experience, or adverse childhood experiences, many members of the study population experience a great deal of allostatic stress and kinesiophobia: “When I move, I hurt.” One of the study team’s theories as to why participants initially responded more positively to the CIH arm is that there was less movement involved.

Future directions may include examining the biological or neurological mechanisms underlying the interventions’ impact.

Dr. Flynn shared a resource that she noted would be helpful in defining SMART Designs and outlining some of the advantages and disadvantages:  https://jamanetwork.com/journals/jama/article-abstract/2800681

Grand Rounds September 6, 2024: Conventional, Complementary, and Integrative Pain Therapies in a Military Population With Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design (Ardith Z. Doorenbos, PhD, RN; Diane M. Flynn, MD, MPH)

Speakers:

Ardith Z. Doorenbos, PhD, RN
Professor
Department of Biobehavioral Nursing Science
College of Nursing
University of Illinois, Chicago

Diane M. Flynn, MD, MPH
Primary Care Pain Management Advisor
Interdisciplinary Pain Management Center
Madigan Army Medical Center
Tacoma, WA

Title: Conventional, Complementary, and Integrative Pain Therapies in a Military Population With Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design

Date: Friday, September 6, 2024, 1:00-2:00 p.m. ET

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August 5, 2021: GRACE Trial Seeks More Options for Sickle Cell Pain

The GRACE trial, an NIH Collaboratory Trial, is studying real-world implementation of nonpharmacologic pain management strategies for patients with sickle cell disease. Dr. Robert Molokie, a GRACE co–principal investigator, discussed the study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

One innovation the GRACE trial is bringing to the NIH Collaboratory’s portfolio of pragmatic trials is its use of a sequential, multiple-assignment, randomized trial (SMART) design. In this adaptive approach, patients are randomly assigned to treatment groups, and those who do not respond to the treatment undergo a secondary randomization to either continue with the initial intervention or switch to the other group.

The GRACE trial is studying acupuncture and guided relaxation with the goals of reducing pain and reducing patients’ reliance on opioid medication.

Using a pragmatic, adaptive design, Molokie said, “I think we will get the most realistic findings of how these therapeutic interventions work, whereas in more classic trials they’re going to end up with such a group of selected patients that it may not be as generalizable as a pragmatic clinical trial.” Molokie is a clinical associate professor of medicine at the University of Illinois Chicago.

GRACE is supported by the NIH through the NIH HEAL Initiative under a grant from the National Center for Complementary and Integrative Health and receives logistical and technical support from the PRISM Resource Coordinating Center.

 

Screen shot of interview with Dr. Robert Molokie
Dr. Robert Molokie