title: Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Low back pain is a highly prevalent condition in the United States and has a staggeringly negative impact on society in terms of expenses and disability. It has previously been suggested that rehabilitation strategies for persons with recurrent low back pain should be directed to the medial back muscles as these muscles provide functional support of the lumbar region. However, many individuals with low back pain cannot safely and effectively induce trunk muscle adaptation using traditional high-load resistance exercise, and no viable low-load protocols to induce trunk extensor muscle adaptation exist. Herein, we present the study protocol for a randomized controlled trial that will investigate the "cross-transfer" of effects of a novel exercise modality, blood flow restricted exercise, on cross-sectional area (primary outcome), strength and endurance (secondary outcomes) of trunk extensor muscles, as well as the pain, disability, and rate of recurrence of low back pain (tertiary outcomes).
  
  
  METHODS
  This is a single-blinded, single-site, randomized controlled trial. A minimum of 32 (and up to 40) subjects aged 18 to 50 years with recurrent low back pain and poor trunk extensor muscle endurance will be recruited, enrolled and randomized. After completion of baseline assessments, participants will be randomized in a 1:1 ratio to receive a 10-week resistance exercise training program with blood flow restriction (BFR exercise group) or without blood flow restriction (control exercise group). Repeat assessments will be taken immediately post intervention and at 12 weeks after the completion of the exercise program. Furthermore, once every 4 weeks during a 36-week follow-up period, participants will be asked to rate their perceived disability and back pain over the past 14 days.
  
  
  CONCLUSIONS
  This study will examine the potential for blood flow restricted exercise applied to appendicular muscles to result in a "cross-transfer" of therapeutic effect to the lumbar musculature in individuals with low back pain. The results of this study will provide important insights into the effectiveness of this novel exercise modality, which could potentially provide the foundation for a cost-effective and easy-to-implement rehabilitation strategy to induce muscle adaptation in the absence of high mechanical and compressive loading on the spine.
  
  
  BACKGROUND
  This trial is registered with ClinicalTrials.gov (registration number: NCT02308189, date of registration: 2 December 2014).
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. amano@ohio.edu.|Clinical and Translational Research Unit (CTRU), Ohio University, Athens, OH, 45701, USA. amano@ohio.edu.
authors: Shinichi
authors: S
authors: Amano
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA.|Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
authors: Arimi Fitri Mat
authors: AF
authors: Ludin
authors: Clinical and Translational Research Unit (CTRU), Ohio University, Athens, OH, 45701, USA. cliftr@ohio.edu.
authors: Rachel
authors: R
authors: Clift
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. nakazawa@ohio.edu.|Office of Research and Grants, Ohio University Heritage College of Osteopathic Medicine, Athens, OH, 45701, USA. nakazawa@ohio.edu.|Department of Biomedical Sciences, Ohio University, Athens, OH, 45701, USA. nakazawa@ohio.edu.
authors: Masato
authors: M
authors: Nakazawa
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. lawt@ohio.edu.|Clinical and Translational Research Unit (CTRU), Ohio University, Athens, OH, 45701, USA. lawt@ohio.edu.|Department of Biomedical Sciences, Ohio University, Athens, OH, 45701, USA. lawt@ohio.edu.|Department of Family Medicine, Ohio University, Athens, OH, 45701, USA. lawt@ohio.edu.
authors: Timothy D
authors: TD
authors: Law
authors: Clinical and Translational Research Unit (CTRU), Ohio University, Athens, OH, 45701, USA. rush@ohio.edu.
authors: Laura J
authors: LJ
authors: Rush
authors: Department of Geriatric Medicine, University of Florida, 2004 Mowry Road, PO Box 100107, Gainesville, FL, 32611, USA. tmanini@ufl.edu.
authors: Todd M
authors: TM
authors: Manini
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. thomasj5@ohio.edu.|Department of Biomedical Sciences, Ohio University, Athens, OH, 45701, USA. thomasj5@ohio.edu.|Division of Physical Therapy, The School of Rehabilitation and Communication Sciences, Ohio University, Athens, OH, 45701, USA. thomasj5@ohio.edu.
authors: James S
authors: JS
authors: Thomas
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. russd@ohio.edu.|Division of Physical Therapy, The School of Rehabilitation and Communication Sciences, Ohio University, Athens, OH, 45701, USA. russd@ohio.edu.
authors: David W
authors: DW
authors: Russ
authors: Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, 250 Irvine Hall, 1 Ohio University, Athens, OH, 43147, USA. clarkb2@ohio.edu.|Department of Biomedical Sciences, Ohio University, Athens, OH, 45701, USA. clarkb2@ohio.edu.|Department of Geriatric Medicine, Ohio University, Institute on Aging, Athens, OH, USA. clarkb2@ohio.edu.
authors: Brian C
authors: BC
authors: Clark
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D012008:Recurrence; D055070:Resistance Training / Q000379:methods*; D016037:Single-Blind Method