Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain

Diane M Flynn, Honor McQuinn, Alexandra Fairchok, Linda H Eaton, Dale J Langford, Tyler Snow, Ardith Z Doorenbos, Diane M Flynn, Honor McQuinn, Alexandra Fairchok, Linda H Eaton, Dale J Langford, Tyler Snow, Ardith Z Doorenbos

Abstract

Chronic pain significantly impairs physical, psychological and social functioning. Among military populations, pain due to injuries sustained both on and off the battlefield is a leading cause of short and long-term disability. Improving the quality of pain care for active duty service members is a major priority of the Department of Defense. This article describes an ongoing comparative effectiveness study which aims to (1) evaluate the benefit of a multimodal complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SRC) prior to an intensive functional restoration (FR) program compared to SRC alone, and (2) identify factors that predict improvement in pain impact following treatment completion. Using a randomized controlled trial design, active duty service members with pain related to musculoskeletal injury are assigned to a 3-week course of either SRC or SRC combined with CIH therapies prior to beginning a 3-week course of FR. Outcomes are collected at baseline, at the end of stage 1 treatment, post-FR, and at 3- and 6-months post-FR. Outcome measures include provider-measured functional assessments and patient-reported assessment through the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The military health system provides a supportive environment for implementation of this research protocol. Challenges to conducting the study have included new technology systems at the study site, slower than projected enrollment, and program delivery issues. These challenges have been successfully managed and have not significantly impacted study participant enrollment and completion of study treatments.

Keywords: Complementary therapies; Integrative health therapies; Military; Rehabilitation; chronic pain.

Figures

Fig. 1
Fig. 1
Schematic diagram of the study design and timeline.

References

    1. Ratcliffe G.E., Enns M.W., Belik S.L., Sareen J. Chronic pain conditions and suicidal ideation and suicide attempts: an epidemiologic perspective. Clin. J. Pain. 2008;24:204–210.
    1. Institute of Medicine . 2011. Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: a Blueprint for Transforming Prevention, Care, Education, and Research.
    1. Lew H.L., Otis J.D., Tun C., Kerns R.D., Clark M.E., Cifu D.X. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J. Rehabil. Res. Dev. 2009;46:697–702.
    1. Gironda R.J., Clark M.E., Ruff R.L., Chait S., Craine M., Walker R., Scholten J. Traumatic brain injury, polytrauma, and pain; challenges and treatment strategies for the polytrauma rehabilitation. Rehabil. Psychol. 2009;54:247–258.
    1. Clark M.E., Walker R.L., Gironda R.J., Scholten J.D. Comparison of pain and emotional symptoms in soldiers with polytrauma; unique aspects of blast experience. Pain Med. 2009;10:447–455.
    1. Nahin R. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J. Pain. 2017;18:247–254.
    1. Kerns R., Otis J., Rosenburg R., Reid C. Veterans' reports of pain and associations with ratings of health, health-risk behaviors, affective distress, and use of the healthcare system. J. Rehabil. Res. Dev. 2003;40:371–380.
    1. Reif S., Adams R.S., Ritter G.A., Williams T.V., Larson M.J. Prevalence of pain diagnoses and burden of pain among active duty soldiers, FY2012. Mil. Med. 2018;0/0:1–8.
    1. Forman-Hoffman V.L., Peloso P.M., Black D.W., Woolson R.F., Letuchy E.M., Doebbeling B.N. Chronic widespread pain in veterans of the first Gulf War: impact of deployment status and associated health effects. J. Pain. 2007;8:954–961.
    1. Office of the Army Surgeon General Pain Management Task Force . 2010. Providing a Standardized DoD and VHA Vision and Approach to Pain Management to Optimize the Care for Warriors and Their Families. Final Report.
    1. Roche-Leboucher G., Petit-Lemanac’h A., Dubus-Bausiere V. Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain. Spine. 2011;36:2235–2242.
    1. Defense & Veterans Center for Integrative Pain Management . 2018. Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
    1. Cook K.F., Buckenmaier C., Gershon R. PASTOR/PROMIS® pain outcomes system: what does it mean to pain specialists? Pain Manag. 2014;4:277–283.
    1. Deyo R.A., Dworkin S.F., Amtmann D. Report of the NIH task force on research standards for chronic low back pain. Pain Med. 2014;15:1249–1267.
    1. Deyo R.A., Ramsey K., Buckley D.I. Performance of a Patient Oriented Outcomes Measurement Information System (PROMIS) short form in older adults with chronic musculoskeletal pain. Pain Med. 2016;17:314–324.
    1. Buckenmaier C.C., Galloway K.T., Polomano R.C., McDuffie M., Kwon N., Gallagher R.M. Preliminary validation of the Defense and veterans pain rating scale (DVPRS) in a military population. Pain Med. 2013;14:110–123.
    1. Rose M., Bjorner J.B., Gandek B., Bruce B., Fries J.F., Ware J.E. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J. Clin. Epidemiol. 2014;67:516–526.
    1. Amtmann D., Cook K., Lai J. Development of a PROMIS item bank to measure pain interference. Pain. 2010;150:173–182.
    1. Pilkonis P., Choi S., Reise S., Stover A., Riley W., Cella D. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®): depression, anxiety, and anger. Assessment. 2011;18:263–283.
    1. Yu L., Buysse D., Pilkonis P. Development of short forms from the PROMIS™ sleep disturbance and Sleep-Related Impairment item banks. Behav. Sleep Med. 2011;10:6–24.
    1. Cella D., Riley W., Hays R. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J. Clin. Epidemiol. 2010;63:1179–1194.
    1. Roland M.O., Morris R.W. A study of the natural history of back pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine. 1983;8:141–144.
    1. Law M., Baptiste S., Carswell A., McColl M.A., Polatajko H., Pollack N. 2005. Canadian Occupation Performance Measure. Toronto, Canada.
    1. Mayer T., Polatin P., Smith B., Gatchel R., Fardon D., Herring S., Smith C., Donelson R., Wong D D., North American Spine Society Committee Contemporary Concepts Review Committee, Spine rehabilitation: secondary and tertiary nonoperative care. Spine J. 2003;3:28S–36S.
    1. Raudenbush S., Bryk A., Cheong Y., Congdon R., Jr. Lincolnwood; IL: 2004. HLM 6: Hierarchical Linear and Nonlinear Modeling.
    1. Tabachnick B.G., Fidell L.S. fourth ed. 2001. Using Multivariate Statistics. Boston, Massachusetts.

Source: PubMed

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