Clinical trial NCT02111278: Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents
Official title: Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Manipulation
Lumbar
Low Back Pain
Manual Therapy
Adolescents
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 35
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.

Detailed description: This is a double blind, randomized controlled, parallel group study. The investigators will consider adolescent patients with a primary complaint of low back pain referred to physical therapy.

The purpose of this study is to determine if the addition of lumbar manipulation will improve function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim of this study is to determine if a modification of a clinical prediction rule by Flynn will be effective in identifying adolescent patients with low back pain who would benefit from lumbar manipulation.

Prior to randomization, patients will complete several self-report measures and then receive a standardized history and physical examination performed by the treating physical therapist. The information collected will include age, sex, duration and nature of symptoms. Standardized physical examination measures include lumbar active range of motion assessment for quality and mobility, lumbar segmental mobility, hip internal rotation range of motion, straight leg raise test, and prone instability test. Treating physical therapists were trained in all evaluation measures before data collection began. Patients are assessed on each item of a modified clinical prediction rule which consists of 4 items; duration of symptoms, symptoms distal to knee, Hip Internal Rotation \>35 degrees, and presence of lumbar segmental hypomobility. The fear avoidance beliefs questionnaire work sub-scale component was removed since the score would likely not be valid in the adolescent population. Meeting 3 of the 4 items was considered to be positive on the rule in this population.

The manipulating therapist who performs the intervention will be aware of treatment allocation, whereas the treating physical therapist and patients are blinded to treatment group allocation. To assess if the patients are successfully blinded to group allocation, the investigator will ask each patient to guess which intervention was performed on them following discharge from therapy.

Randomization is determined by checking a randomly generated computer list that tells the manipulating therapist the assigned group. The computer list was generated by an aide not involved in the study who blindly drew 52 cards that placed an equal number of patients into either the manipulation or sham group.

To address the issue of safety, patients who experience a clinically significant decrease in functional ability or increase in pain will be classified as having an adverse reaction. The minimally clinical important difference for the Patient Specific Functional Scale is \>= 6. While the minimal clinical important difference of the Numeric Pain Rating Scale is 2 points. Following the manipulation or sham intervention patients will be asked if they experienced pain or discomfort during or following the intervention. An interim analysis is planned at the midpoint of the study to assess the safety and efficacy of the intervention. If \>1/3 of patients in the manipulation group have a worsening of symptoms at any follow up, the study will be terminated for safety reasons.

Eligibility criteria: Inclusion Criteria:

* patients 13 to 17 years old
* duration of low back symptoms less than 90 days

Exclusion Criteria:

* contraindication to manipulation. These included "red flags" for physical therapy, previous lumbar surgery, those who had signs consistent with nerve root compression (positive straight-leg test of \< 45 degrees, diminished reflexes, sensation, or lower extremity strength), those who were pregnant, and those diagnosed with, or suspected of having a spondylolysis or spondylolisthesis.

Primary outcomes:
measure: Change in Patient Specific Functional Scale
timeFrame: Initial Evaluation, 1 week, 4 weeks, and 6 month
Secondary outcomes:
measure: Global Rating of Change scale
timeFrame: 1 week, and 4 weeks
measure: Change in Numeric Pain Rating Scale
timeFrame: Initial Evaluation, 1 week, 4 weeks, and 6 month
Other outcomes:
measure: Recurrence of low back pain
timeFrame: 6 months
measure: Sought further treatment
timeFrame: 6 months
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT Ortho Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT East Broad
state: Ohio
city: Westerville
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT Westerville
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Mitchell C Selhorst, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaughn DW, Kenyon LK, Sobeck CM, Smith RE. Spinal manual therapy interventions for pediatric patients: a systematic review. J Man Manip Ther. 2012 Aug;20(3):153-9. doi: 10.1179/2042618612Y.0000000007.
citation: Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
citation: Ndetan H, Evans MW Jr, Hawk C, Walker C. Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey. J Altern Complement Med. 2012 Apr;18(4):347-53. doi: 10.1089/acm.2011.0268. Epub 2012 Mar 2.
citation: Koppenhaver SL, Fritz JM, Hebert JJ, Kawchuk GN, Childs JD, Parent EC, Gill NW, Teyhen DS. Association between changes in abdominal and lumbar multifidus muscle thickness and clinical improvement after spinal manipulation. J Orthop Sports Phys Ther. 2011 Jun;41(6):389-99. doi: 10.2519/jospt.2011.3632. Epub 2011 Apr 6.
citation: Vela LI, Haladay DE, Denegar C. Clinical assessment of low-back-pain treatment outcomes in athletes. J Sport Rehabil. 2011 Feb;20(1):74-88. doi: 10.1123/jsr.20.1.74.
citation: Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011 May;91(5):675-88. doi: 10.2522/ptj.20100229. Epub 2011 Mar 3.
citation: Fritz JM, Koppenhaver SL, Kawchuk GN, Teyhen DS, Hebert JJ, Childs JD. Preliminary investigation of the mechanisms underlying the effects of manipulation: exploration of a multivariate model including spinal stiffness, multifidus recruitment, and clinical findings. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1772-81. doi: 10.1097/BRS.0b013e318216337d.
citation: Stanton TR, Fritz JM, Hancock MJ, Latimer J, Maher CG, Wand BM, Parent EC. Evaluation of a treatment-based classification algorithm for low back pain: a cross-sectional study. Phys Ther. 2011 Apr;91(4):496-509. doi: 10.2522/ptj.20100272. Epub 2011 Feb 17.
citation: Hall AM, Maher CG, Latimer J, Ferreira ML, Costa LO. The patient-specific functional scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. Eur Spine J. 2011 Jan;20(1):79-86. doi: 10.1007/s00586-010-1521-8. Epub 2010 Jul 14.
citation: Humphreys BK. Possible adverse events in children treated by manual therapy: a review. Chiropr Osteopat. 2010 Jun 2;18:12. doi: 10.1186/1746-1340-18-12.
citation: Fritz JM, Clifford SN. Low back pain in adolescents: a comparison of clinical outcomes in sports participants and nonparticipants. J Athl Train. 2010 Jan-Feb;45(1):61-6. doi: 10.4085/1062-6050-45.1.61.
citation: Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
citation: Resnik L, Liu D, Mor V, Hart DL. Predictors of physical therapy clinic performance in the treatment of patients with low back pain syndromes. Phys Ther. 2008 Sep;88(9):989-1004. doi: 10.2522/ptj.20070110. Epub 2008 Aug 8.
citation: Chen KC, Chiu EH. Adolescent idiopathic scoliosis treated by spinal manipulation: a case study. J Altern Complement Med. 2008 Jul;14(6):749-51. doi: 10.1089/acm.2008.0054.
citation: Vohra S, Johnston BC, Cramer K, Humphreys K. Adverse events associated with pediatric spinal manipulation: a systematic review. Pediatrics. 2007 Jan;119(1):e275-83. doi: 10.1542/peds.2006-1392. Epub 2006 Dec 18.
citation: Childs JD, Flynn TW, Fritz JM. A perspective for considering the risks and benefits of spinal manipulation in patients with low back pain. Man Ther. 2006 Nov;11(4):316-20. doi: 10.1016/j.math.2005.09.002. Epub 2006 Jul 12.
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: Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004 Dec 21;141(12):920-8. doi: 10.7326/0003-4819-141-12-200412210-00008.
citation: Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.
citation: O'Neal ML. The pediatric spine: anatomical and dynamic considerations preceding manipulation. Compr Ther. 2003 Summer-Fall;29(2-3):124-9. doi: 10.1007/s12019-003-0016-5.
citation: Clifford SN, Fritz JM. Children and adolescents with low back pain: a descriptive study of physical examination and outcome measurement. J Orthop Sports Phys Ther. 2003 Sep;33(9):513-22. doi: 10.2519/jospt.2003.33.9.513.
citation: McNeely ML, Torrance G, Magee DJ. A systematic review of physiotherapy for spondylolysis and spondylolisthesis. Man Ther. 2003 May;8(2):80-91. doi: 10.1016/s1356-689x(02)00066-8.
citation: 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.
citation: Burton AK, Clarke RD, McClune TD, Tillotson KM. The natural history of low back pain in adolescents. Spine (Phila Pa 1976). 1996 Oct 15;21(20):2323-8. doi: 10.1097/00007632-199610150-00004.