Exercise intervention for unilateral amputees with low back pain: study protocol for a randomised, controlled trial

Joseph G Wasser, Daniel C Herman, MaryBeth Horodyski, Jason L Zaremski, Brady Tripp, Phillip Page, Kevin R Vincent, Heather K Vincent, Joseph G Wasser, Daniel C Herman, MaryBeth Horodyski, Jason L Zaremski, Brady Tripp, Phillip Page, Kevin R Vincent, Heather K Vincent

Abstract

Background: Atraumatic lower limb amputation is a life-changing event for approximately 185,000 persons in the United States each year. A unilateral amputation is associated with rapid changes to the musculoskeletal system including leg and back muscle atrophy, strength loss, gait asymmetries, differential mechanical joint loading and leg length discrepancies. Even with high-quality medical care and prostheses, amputees still develop secondary musculoskeletal conditions such as chronic low back pain (LBP). Resistance training interventions that focus on core stabilization, lumbar strength and dynamic stability during loading have strong potential to reduce LBP and address amputation-related changes to the musculoskeletal system. Home-based resistance exercise programs may be attractive to patients to minimize travel and financial burdens.

Methods/design: This study will be a single-assessor-blinded, pre-post-test randomised controlled trial involving 40 men and women aged 18-60 years with traumatic, unilateral transtibial amputation. Participants will be randomised to a home-based, resistance exercise group (HBRX) or a wait-list control group (CON). The HBRX will consist of 12 weeks of elastic resistance band and bodyweight training to improve core and lumbopelvic strength. Participants will be monitored via Skype or Facetime on a weekly basis. The primary outcome will be pain severity (11-point Numerical Pain Rating Scale; NRSpain). Secondary outcomes will include pain impact on quality of life (Medical Outcomes Short Form 36, Oswestry Disability Index and Roland Morris Disability Questionnaire), kinematics and kinetics of walking gait on an instrumented treadmill, muscle morphology (muscle thickness of multifidus, transversus abdominis, internal oblique), maximal muscle strength of key lumbar and core muscles, and daily step count.

Discussion: The study findings will determine whether a HBRX program can decrease pain severity and positively impact several physiological and mechanical factors that contribute to back pain in unilateral transtibial amputees with chronic LBP. We will determine the relative contribution of the exercise-induced changes in these factors on pain responsiveness in this population.

Trial registration: ClinicalTrials.gov, ID: NCT03300375 . Registered on 2 October 2017.

Keywords: Amputee; Disability; Gait; Low back pain; Physical function; Randomised controlled trial.

Conflict of interest statement

Authors’ information

JGW is a doctoral student in the rehabilitation sciences program at the University of Florida (UF). He received his B.S. degree in applied physiology and kinesiology at UF. His research emphasizes the relationship of low back pain on joint motion and energy expenditure in active and amputee persons.

Ethics approval and consent to participate

This study and its procedures were approved by the University of Florida Institutional Review Board (protocol number 201701256). Written informed consent will be obtained from all candidates who agree to participate and meet all the inclusion/exclusion criteria.

Consent for publication

Not applicable.

Competing interests

Dr. Phil Page currently stands as the Global Director of Clinical Education and Research for Performance Health, manufacturer of TheraBand®, Biofreeze, and Cramer products.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments
Fig. 3
Fig. 3
Elastic resistance band set and stability pad equipment for the home-based resistance

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