Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-02-28
2015-05-31
Brief Summary
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The second purpose will be to determine if there is a subset of physical examination and self-reported variables that are associated with having a successful result (ODQ improvement by at least 6 points) and if the subset of variables are affected by whether or not the subject was in the intervention (video) or control (handout) group.
Detailed Description
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In 1995 a treatment based classification system for patients with acute low back pain was published.(8) Patients were categorized into one of four categories: manipulation, directional exercises (flexion, extension, lateral shift correction), immobilization, or traction. (8)This classification system led to further validation of the categories and clinical prediction rules (CPR) related to best treatment outcomes.(9-11) In 2005, Hicks built upon the initial classification system for immobilization when he published a preliminary CPR identifying which patients were most likely to benefit from lumbar stabilization.(10) Hicks identified the following predictors for patient response to stabilization exercises: individuals younger than age forty, straight leg raise greater than ninety-one degrees, and aberrant motions or a positive prone instability test.(10) Hicks reported a presence of three or more of these variables had a positive likelihood ratio of 4.0 for a 95% confidence interval.(10) However, no studies to date have confirmed such results nor validated this clinical prediction rule.
Home program prescription background Evidence for using video for home program prescription is limited. However, video based home programs have been successfully used for patients with Huntington's disease, traumatic brain injury (TBI), spinal cord injury, brachial plexus injuries, and general shoulder strengthening.(12-15) Medical studies demonstrate that patients comprehend information better when communicated via educational videos as opposed to educational pamphlets about various disorders.(16-18)
Problem Statement:
Currently, there is no literature evaluating the use of video home programs for patients with LBP or identifying who may benefit from this form of clinical education. Home program handouts frequently depict photographs or figures with incorrect form or instructions. Video based home programs demonstrating the stabilization techniques for patients may provide correct form and accurate instructions. With such programs, patient comprehension and technical reproduction of the exercises may improve. Video-based home programs could lead to fewer clinic visits and decreased cost per episode of care.
Given the numerous factors that contribute to limited clinic visits in LBP patients, more effective communication should be beneficial during treatment. We do not know if patient learning styles may influence compliance with varying modes of home exercise program prescriptions. Video based home exercise programs may also be a better fit for patients who are more auditory or visual learners as defined by the Visual, Auditory, Reading, Kinesthetic (VARK) learning inventory. (19) Auditory learners prefer information being transferred by listening. Visual learners prefer maps, charts, and perhaps videos over written charts or instructions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Video Home Program Education
Subjects in this group will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a video with verbal instruction for guidance of proper technique and repetitions.
Video
A video with moving demonstration and verbal instruction of the exercise to strengthen low back
Handout Home Program Education
Subjects will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a handout with two dimensional pictures and written instructions for guidance of proper technique and repetitions.
Handout
A handout with a two dimensional picture and written instruction of the exercise to strengthen low back
Interventions
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Video
A video with moving demonstration and verbal instruction of the exercise to strengthen low back
Handout
A handout with a two dimensional picture and written instruction of the exercise to strengthen low back
Eligibility Criteria
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Inclusion Criteria
2. Positive prone instability test
3. Straight leg raise greater than ninety-one degrees
4. Age under 40
Exclusion Criteria
2. Those unable to access video based exercise instructions
3. A prior spinal fusion, tumor, infection
4. Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes
18 Years
50 Years
ALL
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Tiffany Virag, MPT
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Spine Physical Therapy
Madison, Wisconsin, United States
Countries
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References
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Khalil H, Quinn L, van Deursen R, Dawes H, Playle R, Rosser A, Busse M. What effect does a structured home-based exercise programme have on people with Huntington's disease? A randomized, controlled pilot study. Clin Rehabil. 2013 Jul;27(7):646-58. doi: 10.1177/0269215512473762. Epub 2013 Feb 20.
Betker AL, Desai A, Nett C, Kapadia N, Szturm T. Game-based exercises for dynamic short-sitting balance rehabilitation of people with chronic spinal cord and traumatic brain injuries. Phys Ther. 2007 Oct;87(10):1389-98. doi: 10.2522/ptj.20060229. Epub 2007 Aug 21.
Slater SL, Ford JJ, Richards MC, Taylor NF, Surkitt LD, Hahne AJ. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Man Ther. 2012 Jun;17(3):201-12. doi: 10.1016/j.math.2012.01.006. Epub 2012 Mar 3.
Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
Surkitt LD, Ford JJ, Hahne AJ, Pizzari T, McMeeken JM. Efficacy of directional preference management for low back pain: a systematic review. Phys Ther. 2012 May;92(5):652-65. doi: 10.2522/ptj.20100251. Epub 2012 Jan 12.
Li LC, Bombardier C. Physical therapy management of low back pain: an exploratory survey of therapist approaches. Phys Ther. 2001 Apr;81(4):1018-28.
Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Use and costs of prescription medications and alternative treatments in patients with osteoarthritis and chronic low back pain in community-based settings. Pain Pract. 2012 Sep;12(7):550-60. doi: 10.1111/j.1533-2500.2012.00532.x. Epub 2012 Feb 5.
Rundell SD, Davenport TE. Patient education based on principles of cognitive behavioral therapy for a patient with persistent low back pain: a case report. J Orthop Sports Phys Ther. 2010 Aug;40(8):494-501. doi: 10.2519/jospt.2010.3264.
Wentz AC, Garcia SC, Klingensmith GJ, Migeon CJ, Jones GS. Gonadotropin output and response to LRH administration in congenital virilizing adrenal hyperplasia. J Clin Endocrinol Metab. 1976 Feb;42(2):239-46. doi: 10.1210/jcem-42-2-239.
Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D, Butler B, Garber M, Allison S. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2835-43. doi: 10.1097/00007632-200212150-00021.
Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.
Murphy KM, Rasmussen L, Hervey-Jumper SL, Justice D, Nelson VS, Yang LJ. An assessment of the compliance and utility of a home exercise DVD for caregivers of children and adolescents with brachial plexus palsy: a pilot study. PM R. 2012 Mar;4(3):190-7. doi: 10.1016/j.pmrj.2011.08.538. Epub 2011 Nov 16.
Reo JA, Mercer VS. Effects of live, videotaped, or written instruction on learning an upper-extremity exercise program. Phys Ther. 2004 Jul;84(7):622-33.
Armstrong AW, Kim RH, Idriss NZ, Larsen LN, Lio PA. Online video improves clinical outcomes in adults with atopic dermatitis: a randomized controlled trial. J Am Acad Dermatol. 2011 Mar;64(3):502-7. doi: 10.1016/j.jaad.2010.01.051. Epub 2011 Jan 13.
Idriss NZ, Alikhan A, Baba K, Armstrong AW. Online, video-based patient education improves melanoma awareness: a randomized controlled trial. Telemed J E Health. 2009 Dec;15(10):992-7. doi: 10.1089/tmj.2009.0055.
O'Donnell L, San Doval A, Duran R, O'Donnell CR. The effectiveness of video-based interventions in promoting condom acquisition among STD clinic patients. Sex Transm Dis. 1995 Mar-Apr;22(2):97-103. doi: 10.1097/00007435-199503000-00004.
Hicks GE, Fritz JM, Delitto A, Mishock J. Interrater reliability of clinical examination measures for identification of lumbar segmental instability. Arch Phys Med Rehabil. 2003 Dec;84(12):1858-64. doi: 10.1016/s0003-9993(03)00365-4.
Persson AV, Frusha JD, Chevalier RJ. Rapid preparation of lecture slides. Surg Clin North Am. 1985 Feb;65(1):139-48. doi: 10.1016/s0039-6109(16)43538-3.
Inott T, Kennedy BB. Assessing learning styles: practical tips for patient education. Nurs Clin North Am. 2011 Sep;46(3):313-20, vi. doi: 10.1016/j.cnur.2011.05.006.
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
Jensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994 Sep;58(3):387-392. doi: 10.1016/0304-3959(94)90133-3.
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
George SZ, Valencia C, Beneciuk JM. A psychometric investigation of fear-avoidance model measures in patients with chronic low back pain. J Orthop Sports Phys Ther. 2010 Apr;40(4):197-205. doi: 10.2519/jospt.2010.3298.
George SZ, Stryker SE. Fear-avoidance beliefs and clinical outcomes for patients seeking outpatient physical therapy for musculoskeletal pain conditions. J Orthop Sports Phys Ther. 2011 Apr;41(4):249-59. doi: 10.2519/jospt.2011.3488. Epub 2011 Feb 18.
Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J. Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000;4(3):259-66. doi: 10.1053/eujp.2000.0178.
Chaory K, Fayad F, Rannou F, Lefevre-Colau MM, Fermanian J, Revel M, Poiraudeau S. Validation of the French version of the fear avoidance belief questionnaire. Spine (Phila Pa 1976). 2004 Apr 15;29(8):908-13. doi: 10.1097/00007632-200404150-00018.
Fritz JM, George SZ. Identifying psychosocial variables in patients with acute work-related low back pain: the importance of fear-avoidance beliefs. Phys Ther. 2002 Oct;82(10):973-83.
Woby SR, Watson PJ, Roach NK, Urmston M. Adjustment to chronic low back pain--the relative influence of fear-avoidance beliefs, catastrophizing, and appraisals of control. Behav Res Ther. 2004 Jul;42(7):761-74. doi: 10.1016/S0005-7967(03)00195-5.
Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.
Waddell G, Somerville D, Henderson I, Newton M. Objective clinical evaluation of physical impairment in chronic low back pain. Spine (Phila Pa 1976). 1992 Jun;17(6):617-28. doi: 10.1097/00007632-199206000-00001.
Maher CG, Simmonds M, Adams R. Therapists' conceptualization and characterization of the clinical concept of spinal stiffness. Phys Ther. 1998 Mar;78(3):289-300. doi: 10.1093/ptj/78.3.289.
Nachemson AL. Advances in low-back pain. Clin Orthop Relat Res. 1985 Nov;(200):266-78.
Beurskens AJHM, de Vet HCW, Koke AJA. Responsiveness of functional status in low back pain: a comparison of different instruments. Pain. 1996 Apr;65(1):71-76. doi: 10.1016/0304-3959(95)00149-2.
Related Links
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American Pain Foundation
Other Identifiers
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2012-0672
Identifier Type: -
Identifier Source: org_study_id