TY - JOUR
T1 - Protocol for mindfulness-oriented recovery enhancement (MORE) in the management of lumbosacral radiculopathy/radiculitis symptoms
T2 - A randomized controlled trial
AU - Wexler, Ryan S.
AU - Fox, Devon J.
AU - Edmond, Hannah
AU - Lemau, Johnny
AU - ZuZero, Danielle
AU - Bollen, Melissa
AU - Montenegro, Diane
AU - Parikshak, Anand
AU - Thompson, Austin R.
AU - Carlson, Nels L.
AU - Carlson, Hans L.
AU - Wentz, Anna E.
AU - Bradley, Ryan
AU - Hanes, Douglas A.
AU - Zwickey, Heather
AU - Pickworth, Courtney K.
N1 - Funding Information:
We would like to thank Drs. Lynn Marshall and Angela Senders for their expertise and contributions in study design and implementation. We would also like to thank the Naturopathic Medical Student Association and Helfgott Research Institute for their financial contributions to the success of the study.
Publisher Copyright:
© 2022
PY - 2022/8
Y1 - 2022/8
N2 - Introduction: Lumbosacral radiculopathy/radiculitis (LR) or “sciatica” is a commonly intractable sequelae of chronic low back pain (LBP), and challenges in the treatment of LR indicate that persistent pain may have both mechanical and neuropathic origins. Mindfulness-based interventions have been demonstrated to be effective tools in mitigating self-reported pain in LBP patients. This paper describes the protocol for a randomized controlled trial (RCT) evaluating the effects of the specific mindfulness-based intervention Mindfulness-Oriented Recovery Enhancement (MORE) on LR symptoms and sequelae, including mental health and physical function. Methods: Participants recruited from the Portland, OR area are screened before completing a baseline visit that includes a series of self-report questionnaires and surface electromyography (sEMG) of the lower extremity. Upon enrollment, participants are randomly assigned to the MORE (experimental) group or treatment as usual (control) group for 8 weeks. Self-reported assessments and sEMG studies are repeated after the intervention is complete for pre/post-intervention comparisons. The outcome measures evaluate self-reported pain, physical function, quality of life, depression symptoms, trait mindfulness, and reinterpretation of pain, with surface electromyography (sEMG) findings evaluating objective physical function in patients with LR. To our knowledge, this is the first trial to date using an objective measure, sEMG, to evaluate the effects of a mindfulness-based intervention on LR symptoms. Hypotheses: We hypothesize that MORE will be effective in improving self-reported pain, physical function, quality of life, depression symptoms, mindfulness, and reinterpretation of pain scores after 8 weeks of mindfulness training as compared to treatment as usual. Additionally, we hypothesize that individuals in the MORE group with abnormal sEMG findings at baseline will have improved sEMG findings at their 8-week follow-up visit.
AB - Introduction: Lumbosacral radiculopathy/radiculitis (LR) or “sciatica” is a commonly intractable sequelae of chronic low back pain (LBP), and challenges in the treatment of LR indicate that persistent pain may have both mechanical and neuropathic origins. Mindfulness-based interventions have been demonstrated to be effective tools in mitigating self-reported pain in LBP patients. This paper describes the protocol for a randomized controlled trial (RCT) evaluating the effects of the specific mindfulness-based intervention Mindfulness-Oriented Recovery Enhancement (MORE) on LR symptoms and sequelae, including mental health and physical function. Methods: Participants recruited from the Portland, OR area are screened before completing a baseline visit that includes a series of self-report questionnaires and surface electromyography (sEMG) of the lower extremity. Upon enrollment, participants are randomly assigned to the MORE (experimental) group or treatment as usual (control) group for 8 weeks. Self-reported assessments and sEMG studies are repeated after the intervention is complete for pre/post-intervention comparisons. The outcome measures evaluate self-reported pain, physical function, quality of life, depression symptoms, trait mindfulness, and reinterpretation of pain, with surface electromyography (sEMG) findings evaluating objective physical function in patients with LR. To our knowledge, this is the first trial to date using an objective measure, sEMG, to evaluate the effects of a mindfulness-based intervention on LR symptoms. Hypotheses: We hypothesize that MORE will be effective in improving self-reported pain, physical function, quality of life, depression symptoms, mindfulness, and reinterpretation of pain scores after 8 weeks of mindfulness training as compared to treatment as usual. Additionally, we hypothesize that individuals in the MORE group with abnormal sEMG findings at baseline will have improved sEMG findings at their 8-week follow-up visit.
KW - Low back pain
KW - Lumbosacral radiculopathy
KW - Mindfulness
KW - Mindfulness-oriented recovery enhancement
KW - RCT protocol
KW - Virtual intervention
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U2 - 10.1016/j.conctc.2022.100962
DO - 10.1016/j.conctc.2022.100962
M3 - Article
AN - SCOPUS:85133529954
SN - 2451-8654
VL - 28
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100962
ER -