Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009)

Steven Z George, John D Childs, Deydre S Teyhen, Samuel S Wu, Alison C Wright, Jessica L Dugan, Michael E Robinson, Steven Z George, John D Childs, Deydre S Teyhen, Samuel S Wu, Alison C Wright, Jessica L Dugan, Michael E Robinson

Abstract

Background: There are few effective strategies reported for the primary prevention of low back pain (LBP). Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs.

Methods/design: Consecutive Soldiers participating in advanced individual training (AIT) will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP) alone, a CSEP with a psychosocial education (PSEP), a traditional exercise (TEP), or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period) and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles). We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system. Soldiers will receive a monthly email that queries whether any LBP was experienced in the previous calendar month. Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made between each of the randomly assigned prevention programs to test our hypotheses related to determining which of the 4 programs is most effective.

Discussion: We have presented the design and protocol for the POLM trial. Completion of this trial will provide important information on how to effectively train Soldiers for the prevention of LBP.

Trial registration: ClinicalTrials.gov NCT00373009.

Figures

Figure 1
Figure 1
Proposed study design of the prevention of low back pain in the military (POLM) trial. LBP, low back pain; AIT, advanced individual training; CSEP, core stabilization exercise program; PSEP, psychosocial education program; TEP, traditional exercise program.

References

    1. Mantyselka P, Kumpusalo E, Ahonen R, Kumpusalo A, Kauhanen J, Viinamaki H, Halonen P, Takala J. Pain as a reason to visit the doctor: a study in Finnish primary health care. Pain. 2001;89:175–180. doi: 10.1016/S0304-3959(00)00361-4.
    1. Sternbach RA. Pain and 'hassles' in the United States: findings of the Nuprin pain report. Pain. 1986;27:69–80. doi: 10.1016/0304-3959(86)90224-1.
    1. Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993;9:174–182.
    1. Walker BF, Muller R, Grant WD. Low back pain in Australian adults: prevalence and associated disability. J Manipulative Physiol Ther. 2004;27:238–244. doi: 10.1016/j.jmpt.2004.02.002.
    1. Stang P, Von Korff M, Galer BS. Reduced labor force participation among primary care patients with headache. J Gen Intern Med. 1998;13:296–302. doi: 10.1046/j.1525-1497.1998.00094.x.
    1. Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003;290:2443–2454. doi: 10.1001/jama.290.18.2443.
    1. Estimates of absolute and relative morbidity burdens attributable to various illnesses and injuries, U.S. Armed Forces, 2002. 9:15. Department of the Army; 2003. (Army Medical Surveillance Activity (AMSA)).
    1. Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work. 2002;18:99–113.
    1. Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000;18:33–40. doi: 10.1016/S0749-3797(00)00107-0.
    1. Frank JW, Kerr MS, Brooker AS, DeMaio SE, Maetzel A, Shannon HS, Sullivan TJ, Norman RW, Wells RP. Disability resulting from occupational low back pain. Part I: What do we know about primary prevention? A review of the scientific evidence on prevention before disability begins. Spine. 1996;21:2908–2917. doi: 10.1097/00007632-199612150-00024.
    1. Frank JW, Brooker AS, DeMaio SE, Kerr MS, Maetzel A, Shannon HS, Sullivan TJ, Norman RW, Wells RP. Disability resulting from occupational low back pain. Part II: What do we know about secondary prevention? A review of the scientific evidence on prevention after disability begins. Spine. 1996;21:2918–2929. doi: 10.1097/00007632-199612150-00025.
    1. Linton SJ, van Tulder MW. Preventive interventions for back and neck pain problems: what is the evidence? Spine. 2001;26:778–787. doi: 10.1097/00007632-200104010-00019.
    1. Scheer SJ, Radack KL, O'Brien DR. Randomized controlled trials in industrial low back pain relating to return to work. Part 1. Acute interventions. Arch Phys Med Rehabil. 1995;76:966–973. doi: 10.1016/S0003-9993(95)80076-X.
    1. Goldby LJ, Moore AP, Doust J, Trew ME. A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Spine. 2006;31:1083–1093. doi: 10.1097/01.brs.0000216464.37504.64.
    1. Hides JA, Jull GA, Richardson CA. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine. 2001;26:E243–E248. doi: 10.1097/00007632-200106010-00004.
    1. O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine. 1997;22:2959–2967. doi: 10.1097/00007632-199712150-00020.
    1. Cholewicki J, McGill SM. Mechanical stability of the in vivo lumbar spine: implications for injury and chronic low back pain. Clin Biomech (Bristol , Avon ) 1996;11:1–15. doi: 10.1016/0268-0033(95)00035-6.
    1. Crisco JJ, III, Panjabi MM. The intersegmental and multisegmental muscles of the lumbar spine. A biomechanical model comparing lateral stabilizing potential. Spine. 1991;16:793–799. doi: 10.1097/00007632-199107000-00018.
    1. Hodges PW, Richardson CA. Contraction of the abdominal muscles associated with movement of the lower limb. Phys Ther. 1997;77:132–142.
    1. Hodges PW, Richardson CA. Relationship between limb movement speed and associated contraction of the trunk muscles. Ergonomics. 1997;40:1220–1230. doi: 10.1080/001401397187469.
    1. Hodges PW, Richardson CA. Feedforward contraction of transversus abdominis is not influenced by the direction of arm movement. Exp Brain Res. 1997;114:362–370. doi: 10.1007/PL00005644.
    1. Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. Three dimensional preparatory trunk motion precedes asymmetrical upper limb movement. Gait Posture. 2000;11:92–101. doi: 10.1016/S0966-6362(99)00055-7.
    1. Hodges PW, Cresswell AG, Thorstensson A. Perturbed upper limb movements cause short-latency postural responses in trunk muscles. Exp Brain Res. 2001;138:243–250. doi: 10.1007/s002210100693.
    1. Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine. 1996;21:2640–2650. doi: 10.1097/00007632-199611150-00014.
    1. Hodges PW, Richardson CA. Delayed postural contraction of transversus abdominis in low back pain associated with movement of the lower limb. J Spinal Disord. 1998;11:46–56. doi: 10.1097/00002517-199802000-00008.
    1. Hodges PW, Richardson CA. Altered trunk muscle recruitment in people with low back pain with upper limb movement at different speeds. Arch Phys Med Rehabil. 1999;80:1005–1012. doi: 10.1016/S0003-9993(99)90052-7.
    1. Hides JA, Stokes MJ, Saide M, Jull GA, Cooper DH. Evidence of lumbar multifidus muscle wasting ipsilateral to symptoms in patients with acute/subacute low back pain. Spine. 1994;19:165–172. doi: 10.1097/00007632-199401001-00009.
    1. Mattila M, Hurme M, Alaranta H, Paljarvi L, Kalimo H, Falck B, Lehto M, Einola S, Jarvinen M. The multifidus muscle in patients with lumbar disc herniation. A histochemical and morphometric analysis of intraoperative biopsies. Spine. 1986;11:732–738. doi: 10.1097/00007632-198609000-00013.
    1. Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine. 1993;18:575–581. doi: 10.1097/00007632-199304000-00009.
    1. Rantanen J, Hurme M, Falck B, Alaranta H, Nykvist F, Lehto M, Einola S, Kalimo H. The lumbar multifidus muscle five years after surgery for a lumbar intervertebral disc herniation. Spine. 1993;18:568–574. doi: 10.1097/00007632-199304000-00008.
    1. Hides JA, Richardson CA, Jull GA. Multifidus muscle recovery is not automatic after resolution of acute, first-episode low back pain. Spine. 1996;21:2763–2769. doi: 10.1097/00007632-199612010-00011.
    1. McGill SM. Kinetic potential of the lumbar trunk musculature about three orthogonal orthopaedic axes in extreme postures. Spine. 1991;16:809–815. doi: 10.1097/00007632-199107000-00021.
    1. Cholewicki J, Panjabi MM, Khachatryan A. Stabilizing function of trunk flexor-extensor muscles around a neutral spine posture. Spine. 1997;22:2207–2212. doi: 10.1097/00007632-199710010-00003.
    1. Lee JH, Hoshino Y, Nakamura K, Kariya Y, Saita K, Ito K. Trunk muscle weakness as a risk factor for low back pain. A 5-year prospective study. Spine. 1999;24:54–57. doi: 10.1097/00007632-199901010-00013.
    1. Niemisto L, Lahtinen-Suopanki T, Rissanen P, Lindgren KA, Sarna S, Hurri H. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain. Spine. 2003;28:2185–2191. doi: 10.1097/01.BRS.0000085096.62603.61.
    1. Biering-Sorensen F. Low back trouble in a general population of 30-, 40-, 50-, and 60-year-old men and women. Study design, representativeness and basic results. Dan Med Bull. 1982;29:289–299.
    1. Biering-Sorensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine. 1984;9:106–119. doi: 10.1097/00007632-198403000-00002.
    1. McGill SM. Low back exercises: evidence for improving exercise regimens. Phys Ther. 1998;78:754–765.
    1. McGill SM, Norman RW. Potential of lumbodorsal fascia forces to generate back extension moments during squat lifts. J Biomed Eng. 1988;10:312–318. doi: 10.1016/0141-5425(88)90060-X.
    1. Helewa A, Goldsmith CH, Lee P, Smythe HA, Forwell L. Does strengthening the abdominal muscles prevent low back pain--a randomized controlled trial. J Rheumatol. 1999;26:1808–1815.
    1. Burton AK, Tillotson KM, Main CJ, Hollis S. Psychosocial predictors of outcome in acute and subchronic low back trouble. Spine. 1995;20:722–728. doi: 10.1097/00007632-199503150-00014.
    1. Gatchel RJ, Polatin PB, Mayer TG. The dominant role of psychosocial risk factors in the development of chronic low back pain disability. Spine. 1995;20:2702–2709. doi: 10.1097/00007632-199512150-00011.
    1. Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine. 1999;24:2484–2491. doi: 10.1097/00007632-199912010-00010.
    1. George SZ, Fritz JM, Bialosky JE, Donald DA. The effect of a fear-avoidance-based physical therapy intervention for patients with acute low back pain: results of a randomized clinical trial. Spine. 2003;28:2551–2560. doi: 10.1097/01.BRS.0000096677.84605.A2.
    1. Linton SJ, Boersma K, Jansson M, Svard L, Botvalde M. The Effects of Cognitive-Behavioral and Physical Therapy Preventive Interventions on Pain-Related Sick Leave: A Randomized Controlled Trial. Clin J Pain. 2005;21:109–119. doi: 10.1097/00002508-200503000-00001.
    1. Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine. 2002;27:E109–E120. doi: 10.1097/00007632-200203010-00017.
    1. Pincus T, Vlaeyen JW, Kendall NA, Von Korff MR, Kalauokalani DA, Reis S. Cognitive-behavioral therapy and psychosocial factors in low back pain: directions for the future. Spine. 2002;27:E133–E138. doi: 10.1097/00007632-200203010-00020.
    1. Vlaeyen JW, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000;85:317–332. doi: 10.1016/S0304-3959(99)00242-0.
    1. Lethem J, Slade PD, Troup JDG, Bentley G. Outline of a fear-avoidance model of exaggerated pain perception-I. Behav Res Ther. 1983;21:401–408. doi: 10.1016/0005-7967(83)90009-8.
    1. Sullivan MJ, Thorn B, Haythornthwaite JA, Keefe F, Martin M, Bradley LA, Lefebvre JC. Theoretical perspectives on the relation between catastrophizing and pain. Clin J Pain. 2001;17:52–64. doi: 10.1097/00002508-200103000-00008.
    1. Sullivan MJ, Stanish W, Waite H, Sullivan M, Tripp DA. Catastrophizing, pain, and disability in patients with soft-tissue injuries. Pain. 1998;77:253–260. doi: 10.1016/S0304-3959(98)00097-9.
    1. Severeijns R, Vlaeyen JW, van den Hout MA, Weber WE. Pain catastrophizing predicts pain intensity, disability, and psychological distress independent of the level of physical impairment. Clin J Pain. 2001;17:165–172. doi: 10.1097/00002508-200106000-00009.
    1. 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;52:157–168. doi: 10.1016/0304-3959(93)90127-B.
    1. Crombez G, Vlaeyen JW, Heuts PH, Lysens R. Pain-related fear is more disabling than pain itself: evidence on the role of pain-related fear in chronic back pain disability. Pain. 1999;80:329–339. doi: 10.1016/S0304-3959(98)00229-2.
    1. Asmundson GJ, Norton GR, Allerdings MD. Fear and avoidance in dysfunctional chronic back pain patients. Pain. 1997;69:231–236. doi: 10.1016/S0304-3959(96)03288-5.
    1. Fritz JM, George SZ, Delitto A. The role of fear avoidance beliefs in acute low back pain: relationships with current and future disability and work status. Pain. 2001;94:7–15. doi: 10.1016/S0304-3959(01)00333-5.
    1. Picavet HS, Vlaeyen JW, Schouten JS. Pain catastrophizing and kinesiophobia: predictors of chronic low back pain. Am J Epidemiol. 2002;156:1028–1034. doi: 10.1093/aje/kwf136.
    1. Klenerman L, Slade PD, Stanley IM, Pennie B, Reilly JP, Atchison LE, Troup JD, Rose MJ. The prediction of chronicity in patients with an acute attack of low back pain in a general practice setting. Spine. 1995;20:478–484. doi: 10.1097/00007632-199502001-00012.
    1. Burton AK, Erg E. Back injury and work loss: biomechanical and psychosocial influences. Spine. 1997;22:2575–2580. doi: 10.1097/00007632-199711010-00021.
    1. Linton SJ, Andersson T. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. Spine. 2000;25:2825–2831. doi: 10.1097/00007632-200011010-00017.
    1. Symonds TL, Burton AK, Tillotson KM, Main CJ. Absence resulting from low back trouble can be reduced by psychosocial intervention at the work place. Spine. 1995;20:2738–2745. doi: 10.1097/00007632-199512150-00016.
    1. Buchbinder R, Jolley D, Wyatt M. 2001 Volvo Award Winner in Clinical Studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice. Spine. 2001;26:2535–2542. doi: 10.1097/00007632-200112010-00005.
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Podiatr Med Assoc. 2001;91:437–442.
    1. Watson L, Small R, Brown S, Dawson W, Lumley J. Mounting a community-randomized trial: sample size, matching, selection, and randomization issues in PRISM. Control Clin Trials. 2004;25:235–250. doi: 10.1016/j.cct.2003.12.002.
    1. Ornstein S, Jenkins RG, Nietert PJ, Feifer C, Roylance LF, Nemeth L, Corley S, Dickerson L, Bradford WD, Litvin C. A multimethod quality improvement intervention to improve preventive cardiovascular care: a cluster randomized trial. Ann Intern Med. 2004;141:523–532.
    1. Olsen OE, Myklebust G, Engebretsen L, Holme I, Bahr R. Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ. 2005;330:449. doi: 10.1136/bmj.38330.632801.8F.
    1. Richardson CA, Jull GA. Muscle control-pain control: What exercises would you prescribe? Manual Therapy. 1995;1:2–2. doi: 10.1054/math.1995.0243.
    1. Burton AK, Waddell G. Clinical guidelines in the management of low back pain. Baillieres Clin Rheumatol. 1998;12:17–35. doi: 10.1016/S0950-3579(98)80004-6.
    1. Ware JE, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care. 1995;33:AS264–AS279. doi: 10.1097/00005650-199501001-00005.
    1. Spielberger CD, Gorsuch RL, Lushene RE, Vagg PR, Jacobs GA. Manual for the state and trait anxiety inventory (form Y). Palo Alto, CA, Consulting Psychologists Press; 1983.
    1. Whisman MA, Perez JE, Ramel W. Factor structure of the Beck Depression Inventory-Second Edition (BDI-II) in a student sample. J Clin Psychol. 2000;56:545–551. doi: 10.1002/(SICI)1097-4679(200004)56:4<545::AID-JCLP7>;2-U.
    1. Schotte CK, Maes M, Cluydts R, De Doncker D, Cosyns P. Construct validity of the Beck Depression Inventory in a depressive population. J Affect Disord. 1997;46:115–125. doi: 10.1016/S0165-0327(97)00094-3.
    1. Chibnall JT, Tait RC. The short form of the Beck Depression Inventory: validity issues with chronic pain patients. Clin J Pain. 1994;10:261–266.
    1. McNeil DW, Rainwater AJ. Development of the Fear of Pain Questionnaire--III. J Behav Med. 1998;21:389–410. doi: 10.1023/A:1018782831217.
    1. Albaret MC, Munoz Sastre MT, Cottencin A, Mullet E. The Fear of Pain questionnaire: factor structure in samples of young, middle-aged and elderly European people. Eur J Pain. 2004;8:273–281. doi: 10.1016/j.ejpain.2003.09.005.
    1. Osman A, Breitenstein JL, Barrios FX, Gutierrez PM, Kopper BA. The Fear of Pain Questionnaire-III: further reliability and validity with nonclinical samples. J Behav Med. 2002;25:155–173. doi: 10.1023/A:1014884704974.
    1. Symonds TL, Burton AK, Tillotson KM, Main CJ. Do attitudes and beliefs influence work loss due to low back trouble? Occup Med (Lond) 1996;46:25–32.
    1. Waddell G, Somerville D, Henderson I, Newton M. Objective clinical evaluation of physical impairment in chronic low back pain. Spine. 1992;17:617–628. doi: 10.1097/00007632-199206000-00001.
    1. Hodges PW, Pengel LH, Herbert RD, Gandevia SC. Measurement of muscle contraction with ultrasound imaging. Muscle Nerve. 2003;27:682–692. doi: 10.1002/mus.10375.
    1. Teyhen DS, Miltenberger CE, Deiters HM, Del Toro YM, Pulliam JN, Childs JD, Boyles RE, Flynn TW. The use of ultrasound imaging of the abdominal drawing-in maneuver in subjects with low back pain. J Orthop Sports Phys Ther. 2005;35:346–355.
    1. Hides JA, Richardson CA, Jull GA. Magnetic resonance imaging and ultrasonography of the lumbar multifidus muscle. Comparison of two different modalities. Spine. 1995;20:54–58. doi: 10.1097/00007632-199501000-00010.
    1. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66:271–273.
    1. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25:2940–2953. doi: 10.1097/00007632-200011150-00017.
    1. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine. 2000;25:3115–3124. doi: 10.1097/00007632-200012150-00006.
    1. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: development and validation. Psychological Assessment. 1995;7:524–532. doi: 10.1037/1040-3590.7.4.524.
    1. Larsen K, Weidick F, Leboeuf-Yde C. Can passive prone extensions of the back prevent back problems? A randomized, controlled intervention trial of 314 military conscripts. Spine. 2002;27:2747–2752. doi: 10.1097/00007632-200212150-00002.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever