Clinical trial NCT03368638: Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking
Official title: Neural And Hip Mobilizations In Patients With Neurogenic Claudication Associated With Degenerative Lumbar Spinal Stenosis: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Degenerative lumbar spinal stenosis
Neural mobilization
Hip extension mobilization
Case series
Neurogenic claudication
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case Series
Primary purpose: TREATMENT

Brief summary: Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Adults aged between 50-89 years old
* Intermittent unilateral or bilateral leg pain occurring with walking and standing activities that is relieved only with sitting or by assuming flexed positions
* Magnetic Resonance Imaging (MRI) confirmation of lumbar spinal stenosis
* Leg symptoms greater than 4/10 and provoked within 15 minutes of walking

Exclusion Criteria:

* Prior lumbar surgery
* Spinal injection in last 6 weeks
* Impaired walking tolerance due to factors other than neurogenic claudication
* Inability to follow the rater's instructions
* Any medical contra-indication for hip mobilizations in extension or flexion
* Current medico-legal issues

Primary outcomes:
measure: Change in Swiss Spinal Stenosis Questionnaire
timeFrame: Baseline, 3-6 weeks, 3-6 months
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 3-6 weeks, 3-6 months
measure: Change in Total Ambulation Time
timeFrame: Baseline, 3-6 weeks
measure: Change in Time to First Symptoms
timeFrame: Baseline, 3-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Reid D Gehring, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: Jean-Michel Brismee, ScD
role: STUDY_CHAIR
References:
citation: Ammendolia C, Chow N. Clinical outcomes for neurogenic claudication using a multimodal program for lumbar spinal stenosis: a retrospective study. J Manipulative Physiol Ther. 2015 Mar-Apr;38(3):188-94. doi: 10.1016/j.jmpt.2014.12.006. Epub 2015 Jan 22.
citation: Backstrom KM, Whitman JM, Flynn TW. Lumbar spinal stenosis-diagnosis and management of the aging spine. Man Ther. 2011 Aug;16(4):308-17. doi: 10.1016/j.math.2011.01.010. Epub 2011 Mar 2.
citation: Bade M, Cobo-Estevez M, Neeley D, Pandya J, Gunderson T, Cook C. Effects of manual therapy and exercise targeting the hips in patients with low-back pain-A randomized controlled trial. J Eval Clin Pract. 2017 Aug;23(4):734-740. doi: 10.1111/jep.12705. Epub 2017 Jan 27.
citation: Bodack MP, Monteiro M. Therapeutic exercise in the treatment of patients with lumbar spinal stenosis. Clin Orthop Relat Res. 2001 Mar;(384):144-52. doi: 10.1097/00003086-200103000-00017.
citation: Burns SA, Mintken PE, Austin GP, Cleland J. Short-term response of hip mobilizations and exercise in individuals with chronic low back pain: a case series. J Man Manip Ther. 2011 May;19(2):100-7. doi: 10.1179/2042618610Y.0000000007.
citation: Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
citation: Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Psychometric properties of selected tests in patients with lumbar spinal stenosis. Spine J. 2012 Oct;12(10):921-31. doi: 10.1016/j.spinee.2012.05.004. Epub 2012 Jun 28.
citation: Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. doi: 10.4065/75.10.1002.
citation: Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.
citation: Fritz JM, Delitto A, Welch WC, Erhard RE. Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil. 1998 Jun;79(6):700-8. doi: 10.1016/s0003-9993(98)90048-x.
citation: Genevay S, Atlas SJ. Lumbar spinal stenosis. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):253-65. doi: 10.1016/j.berh.2009.11.001.
citation: Gilbert KK, Roger James C, Apte G, Brown C, Sizer PS, Brismee JM, Smith MP. Effects of simulated neural mobilization on fluid movement in cadaveric peripheral nerve sections: implications for the treatment of neuropathic pain and dysfunction. J Man Manip Ther. 2015 Sep;23(4):219-25. doi: 10.1179/2042618614Y.0000000094.
citation: Gilbert KK, Smith MP, Sobczak S, James CR, Sizer PS, Brismee JM. Effects of lower limb neurodynamic mobilization on intraneural fluid dispersion of the fourth lumbar nerve root: an unembalmed cadaveric investigation. J Man Manip Ther. 2015 Dec;23(5):239-45. doi: 10.1179/2042618615Y.0000000009.
citation: Goren A, Yildiz N, Topuz O, Findikoglu G, Ardic F. Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial. Clin Rehabil. 2010 Jul;24(7):623-31. doi: 10.1177/0269215510367539. Epub 2010 Jun 8.
citation: Inufusa A, An HS, Lim TH, Hasegawa T, Haughton VM, Nowicki BH. Anatomic changes of the spinal canal and intervertebral foramen associated with flexion-extension movement. Spine (Phila Pa 1976). 1996 Nov 1;21(21):2412-20. doi: 10.1097/00007632-199611010-00002.
citation: Katz JN, Dalgas M, Stucki G, Katz NP, Bayley J, Fossel AH, Chang LC, Lipson SJ. Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum. 1995 Sep;38(9):1236-41. doi: 10.1002/art.1780380910.
citation: Kanno H, Ozawa H, Koizumi Y, Morozumi N, Aizawa T, Kusakabe T, Ishii Y, Itoi E. Dynamic change of dural sac cross-sectional area in axial loaded magnetic resonance imaging correlates with the severity of clinical symptoms in patients with lumbar spinal canal stenosis. Spine (Phila Pa 1976). 2012 Feb 1;37(3):207-13. doi: 10.1097/BRS.0b013e3182134e73.
citation: Kerrigan DC, Xenopoulos-Oddsson A, Sullivan MJ, Lelas JJ, Riley PO. Effect of a hip flexor-stretching program on gait in the elderly. Arch Phys Med Rehabil. 2003 Jan;84(1):1-6. doi: 10.1053/apmr.2003.50056.
citation: Kobayashi S, Uchida K, Takeno K, Baba H, Suzuki Y, Hayakawa K, Yoshizawa H. Imaging of cauda equina edema in lumbar canal stenosis by using gadolinium-enhanced MR imaging: experimental constriction injury. AJNR Am J Neuroradiol. 2006 Feb;27(2):346-53.
citation: Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine (Phila Pa 1976). 2009 May 1;34(10):985-9. doi: 10.1097/BRS.0b013e31819c0a6b.
citation: Konno S, Kikuchi S, Tanaka Y, Yamazaki K, Shimada Y, Takei H, Yokoyama T, Okada M, Kokubun S. A diagnostic support tool for lumbar spinal stenosis: a self-administered, self-reported history questionnaire. BMC Musculoskelet Disord. 2007 Oct 30;8:102. doi: 10.1186/1471-2474-8-102.
citation: Kreiner DS, Shaffer WO, Baisden JL, Gilbert TJ, Summers JT, Toton JF, Hwang SW, Mendel RC, Reitman CA; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update). Spine J. 2013 Jul;13(7):734-43. doi: 10.1016/j.spinee.2012.11.059.
citation: Lee LW, Zavarei K, Evans J, Lelas JJ, Riley PO, Kerrigan DC. Reduced hip extension in the elderly: dynamic or postural? Arch Phys Med Rehabil. 2005 Sep;86(9):1851-4. doi: 10.1016/j.apmr.2005.03.008.
citation: Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
citation: Macedo LG, Hum A, Kuleba L, Mo J, Truong L, Yeung M, Battie MC. Physical therapy interventions for degenerative lumbar spinal stenosis: a systematic review. Phys Ther. 2013 Dec;93(12):1646-60. doi: 10.2522/ptj.20120379. Epub 2013 Jul 25.
citation: Morishita Y, Hida S, Naito M, Arimizu J, Takamori Y. Neurogenic intermittent claudication in lumbar spinal canal stenosis: the clinical relationship between the local pressure of the intervertebral foramen and the clinical findings in lumbar spinal canal stenosis. J Spinal Disord Tech. 2009 Apr;22(2):130-4. doi: 10.1097/BSD.0b013e318167b054.
citation: Murphy DR, Hurwitz EL, Gregory AA, Clary R. A non-surgical approach to the management of lumbar spinal stenosis: a prospective observational cohort study. BMC Musculoskelet Disord. 2006 Feb 23;7:16. doi: 10.1186/1471-2474-7-16.
citation: Nee RJ, Butler D. Management of peripheral neuropathic pain: Integrating neurobiology, neurodynamics, and clinical evidence. Physical Therapy in Sport. 2006;7(1):36-49
citation: Porter RW, Ward D. Cauda equina dysfunction. The significance of two-level pathology. Spine (Phila Pa 1976). 1992 Jan;17(1):9-15.
citation: Pua YH, Cai CC, Lim KC. Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial. Aust J Physiother. 2007;53(2):83-9. doi: 10.1016/s0004-9514(07)70040-5.
citation: Rademeyer I. Manual therapy for lumbar spinal stenosis: a comprehensive physical therapy approach. Phys Med Rehabil Clin N Am. 2003 Feb;14(1):103-10, vii. doi: 10.1016/s1047-9651(02)00077-3.
citation: Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.
citation: Sugioka T, Hayashino Y, Konno S, Kikuchi S, Fukuhara S. Predictive value of self-reported patient information for the identification of lumbar spinal stenosis. Fam Pract. 2008 Aug;25(4):237-44. doi: 10.1093/fampra/cmn031. Epub 2008 Jun 13.
citation: Tomkins-Lane CC, Holz SC, Yamakawa KS, Phalke VV, Quint DJ, Miner J, Haig AJ. Predictors of walking performance and walking capacity in people with lumbar spinal stenosis, low back pain, and asymptomatic controls. Arch Phys Med Rehabil. 2012 Apr;93(4):647-53. doi: 10.1016/j.apmr.2011.09.023. Epub 2012 Feb 23.
citation: Whitman JM, Flynn TW, Fritz JM. Nonsurgical management of patients with lumbar spinal stenosis: a literature review and a case series of three patients managed with physical therapy. Phys Med Rehabil Clin N Am. 2003 Feb;14(1):77-101, vi-vii. doi: 10.1016/s1047-9651(02)00076-1.
citation: Whitman JM, Flynn TW, Childs JD, Wainner RS, Gill HE, Ryder MG, Garber MB, Bennett AC, Fritz JM. A comparison between two physical therapy treatment programs for patients with lumbar spinal stenosis: a randomized clinical trial. Spine (Phila Pa 1976). 2006 Oct 15;31(22):2541-9. doi: 10.1097/01.brs.0000241136.98159.8c.