Krista Beth Highland1, Audrey Schoomaker2, Winifred Rojas2, Josh Suen2, Ambareen Ahmed2, Zhiwei Zhang2, Sarah Fink Carlin3, Christian E Calilung2, Michael Kent4, Christin McDonough2, Chester C Buckenmaier4. 1. Defense & Veterans Center for Integrative Pain Management, Uniformed Services University of the Health Sciences, Rockville, MD; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD. Electronic address: khighland@dvcipm.org. 2. Defense & Veterans Center for Integrative Pain Management, Uniformed Services University of the Health Sciences, Rockville, MD; The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD. 3. YogaMedics, Huntington Woods, MI. 4. Defense & Veterans Center for Integrative Pain Management, Uniformed Services University of the Health Sciences, Rockville, MD; Walter Reed National Military Medical Center, Bethesda, MD.
Abstract
OBJECTIVE: To examine the feasibility and preliminary effectiveness of an individualized yoga program. DESIGN: Pilot randomized controlled trial. SETTING: Military medical center. PARTICIPANTS: Patients (N=68) with chronic low back pain. INTERVENTIONS:Restorative Exercise and Strength Training for Operational Resilience and Excellence (RESTORE) program (9-12 individual yoga sessions) or treatment as usual (control) for an 8-week period. MAIN OUTCOME MEASURES: The primary outcome was past 24-hour pain (Defense &; Veterans Pain Rating Scale 2.0). Secondary outcomes included disability (Roland-Morris Disability Questionnaire) and physical functioning and symptom burden (Patient-Reported Outcomes Measurement Information System-29 subscales). Assessment occurred at baseline, week 4, week 8, 3-month follow-up, and 6-month follow-up. Exploratory outcomes included the proportion of participants in each group reporting clinically meaningful changes at 3- and 6-month follow-ups. RESULTS: Generalized linear mixed models with sequential Bonferroni-adjusted pairwise significance tests and chi-square analyses examined longitudinal outcomes. Secondary outcome significance tests were Bonferroni adjusted for multiple outcomes. The RESTORE group reported improved pain compared with the control group. Secondary outcomes did not retain significance after Bonferroni adjustments for multiple outcomes, although a higher proportion of RESTORE participants reported clinically meaningfully changes in all outcomes at 3-month follow-up and in symptom burden at 6-month follow-up. CONCLUSIONS: RESTORE may be a viable nonpharmacological treatment for low back pain with minimal side effects, and research efforts are needed to compare the effectiveness of RESTORE delivery formats (eg, group vs individual) with that of other treatment modalities.
RCT Entities:
OBJECTIVE: To examine the feasibility and preliminary effectiveness of an individualized yoga program. DESIGN: Pilot randomized controlled trial. SETTING: Military medical center. PARTICIPANTS: Patients (N=68) with chronic low back pain. INTERVENTIONS: Restorative Exercise and Strength Training for Operational Resilience and Excellence (RESTORE) program (9-12 individual yoga sessions) or treatment as usual (control) for an 8-week period. MAIN OUTCOME MEASURES: The primary outcome was past 24-hour pain (Defense & Veterans Pain Rating Scale 2.0). Secondary outcomes included disability (Roland-Morris Disability Questionnaire) and physical functioning and symptom burden (Patient-Reported Outcomes Measurement Information System-29 subscales). Assessment occurred at baseline, week 4, week 8, 3-month follow-up, and 6-month follow-up. Exploratory outcomes included the proportion of participants in each group reporting clinically meaningful changes at 3- and 6-month follow-ups. RESULTS: Generalized linear mixed models with sequential Bonferroni-adjusted pairwise significance tests and chi-square analyses examined longitudinal outcomes. Secondary outcome significance tests were Bonferroni adjusted for multiple outcomes. The RESTORE group reported improved pain compared with the control group. Secondary outcomes did not retain significance after Bonferroni adjustments for multiple outcomes, although a higher proportion of RESTORE participants reported clinically meaningfully changes in all outcomes at 3-month follow-up and in symptom burden at 6-month follow-up. CONCLUSIONS: RESTORE may be a viable nonpharmacological treatment for low back pain with minimal side effects, and research efforts are needed to compare the effectiveness of RESTORE delivery formats (eg, group vs individual) with that of other treatment modalities.
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