Home Program Education for Patients With Low Back Pain

NCT02427438 | Withdrawn

• 1 other identifier: 2012-0672
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the effect size of the change in Oswestry Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based instruction or standard of care hand-out with pictures and written instructions for subjects meeting the clinical prediction rule for lumbar stabilization. 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.

Conditions

Low Back Pain; Lumbago; Spinal Instability

Keywords

video; handout; home program; stabilization; strengthening; core

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Questionnaire (ODQ)

  The ODQ measures level of disability with patients presenting with low back pain. It is also reliable and has excellent construct validity.(10, 34-36) The ODQ will be assessed at baseline and after eight weeks of therapy to determine the overall success of stabilization based treatment on patient function.(10) The Oswestry has ten sections, one to assess pain and the remaining which assesses functional activities. Each section is scored from 0 to 5 which indicates the level of limitation with that given activity. Each score is then totaled and then doubled to give a percentage of disability. Higher scores on the Oswestry indicate greater levels of disability. A five to six point improvement on the Oswestry is considered the minimum clinically important difference with a fifty percent improvement being defined as "success" by Hicks.

  8 weeks

Secondary Outcomes (1)

• Visual Analog Scale (VAS)

  8 weeks

Other Outcomes (1)

• Fear and Avoidant Behaviors Questionnaire

  8 weeks

Study Arms (2)

Video Home Program Education

ACTIVE COMPARATOR

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.

Other: Video

Handout Home Program Education

ACTIVE COMPARATOR

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.

Other: Handout

Interventions

Video OTHER

A video with moving demonstration and verbal instruction of the exercise to strengthen low back

Video Home Program Education

Handout OTHER

A handout with a two dimensional picture and written instruction of the exercise to strengthen low back

Handout Home Program Education

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• presence of aberrant movement (Gower's sign, painful arc of motion, poor reversal of lumbopelvic rhythm)
• Positive prone instability test
• Straight leg raise greater than ninety-one degrees
• Age under 40

You may not qualify if:

• Anyone not meeting the 3/4 clinical prediction rules
• Those unable to access video based exercise instructions
• A prior spinal fusion, tumor, infection
• Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Spine Physical Therapy

Madison, Wisconsin, 53711, United States

Location

Related Publications (34)

• 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.

  PMID: 22386046 RESULT

• 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.

  PMID: 15733046 RESULT

• 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.

  PMID: 22247407 RESULT

• 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.

  PMID: 11276184 RESULT

• 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.

  PMID: 22304678 RESULT

• 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.

  PMID: 20710087 RESULT

• 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.

  PMID: 770494 RESULT

• 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.

  PMID: 12486357 RESULT

• 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.

  PMID: 16181938 RESULT

• 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.

  PMID: 17612355 RESULT

• 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.

  PMID: 23426565 RESULT

• 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.

  PMID: 17712036 RESULT

• 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.

  PMID: 22088854 RESULT

• 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.

  PMID: 15225081 RESULT

• 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.

  PMID: 21236514 RESULT

• 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.

  PMID: 20028190 RESULT

• 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.

  PMID: 7624818 RESULT

• 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.

  PMID: 14669195 RESULT

• 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.

  PMID: 3992439 RESULT

• 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.

  PMID: 21791266 RESULT

• 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.

  PMID: 11733293 RESULT

• 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.

  PMID: 7838588 RESULT

• 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.

  PMID: 8455963 RESULT

• 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.

  PMID: 20357418 RESULT

• 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.

  PMID: 21335927 RESULT

• 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.

  PMID: 10985869 RESULT

• 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.

  PMID: 15082995 RESULT

• 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.

  PMID: 12350212 RESULT

• 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.

  PMID: 15149897 RESULT

• 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.

  PMID: 11175676 RESULT

• 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.

  PMID: 1308095 RESULT

• 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.

  PMID: 9520974 RESULT

• Nachemson AL. Advances in low-back pain. Clin Orthop Relat Res. 1985 Nov;(200):266-78.

  PMID: 2933201 RESULT

• 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.

  PMID: 8826492 RESULT

Related Links

• American Pain Foundation

MeSH Terms

Conditions

Low Back Pain

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Tiffany Virag, MPT

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 28, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)