Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents

NCT02111278 | Completed

• 1 other identifier: IRB11-00262
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Keywords

Manipulation; Lumbar; Low Back Pain; Manual Therapy; Adolescents

Outcome Measures

Primary Outcomes (1)

• Change in Patient Specific Functional Scale

  The Patient Specific Functional scale asks the participant to nominate 3 important activities they are not able to do or are having difficulty performing because of their back pain. Each activity is scored on a numerical rating scale from 0 (unable to perform) to 10 (able to perform at pre-injury level).

  Initial Evaluation, 1 week, 4 weeks, and 6 month

Secondary Outcomes (2)

• Global Rating of Change scale

  1 week, and 4 weeks

• Change in Numeric Pain Rating Scale

  Initial Evaluation, 1 week, 4 weeks, and 6 month

Other Outcomes (2)

• Recurrence of low back pain

  6 months

• Sought further treatment

  6 months

Study Arms (2)

lumbar Manipulation

EXPERIMENTAL

Patients randomized to this treatment group will receive lumbar manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week.

Other: Lumbar Manipulation; Other: Physical Therapy

Sham Manipulation

PLACEBO COMPARATOR

Patients randomized to this treatment group will receive a sham manipulation during the first 2 physical therapy visits. Patient will receive 4 weeks of physical therapy 2 visits per week.

Other: Sham Manipulation; Other: Physical Therapy

Interventions

Lumbar Manipulation OTHER

The manipulating therapist performs the lumbar manipulation technique. With the patient supine, the therapist stands opposite the side to be manipulated. The patient is passively side-bent away from the therapist. The therapist rotates the thoracic spine and then delivers a quick posterior and inferior thrust through the anterior superior iliac spine. The manipulation is performed on the side the patient reported to be more symptomatic. If the patient is unable to identify a more painful side, the side to be manipulated is left to the manipulating therapist discretion. If a cavitation is experienced, no more manipulations are performed that session. If no cavitation is produced, the patient is repositioned, and the manipulation is attempted again. If no cavitation is experienced again, the therapist attempts to manipulate the opposite side. A maximum of two attempts per side will be attempted.

lumbar Manipulation

Sham Manipulation OTHER

The manipulating therapist will perform the sham lumbar manipulation technique with the patient side-lying. The therapist passively flexes both hips until slight lumbar flexion is noted at the patient's most painful vertebral level. The therapist will take time palpating patient's spine taking care to avoid rotating the spine. The therapist will then place both hands on the same lumbar spinous process. An equal and opposite force is then applied to the spinous process with both hands. No physiologic motion is expected with this technique. The patient will then be setup for the same sham technique on the opposite side. The sham manipulation technique will be performed in an attempt to blind the patient to group allocation. This technique is designed to provide similar hands on treatment time as the manipulation intervention.

Sham Manipulation

Physical Therapy OTHER

Patients will receive 4 weeks of physical therapy with 2 visits per week. The treating physical therapist is blinded to group allocation. The treating physical therapist will prescribe exercises based on patient presentation. Therapy visits last approximately 45-60 minutes depending of patient ability to perform exercises. The treating physical therapist will perform no mobilizations or manipulations on the patient.

Sham Manipulation; lumbar Manipulation

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (3)

Nationwide Children's Hospital Sports and Ortho PT Ortho Center

Columbus, Ohio, 43205, United States

Location

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Related Publications (24)

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  PMID: 23904755 BACKGROUND

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• 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.

  PMID: 22384933 BACKGROUND

• 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.

  PMID: 21471653 BACKGROUND

• 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.

  PMID: 21411824 BACKGROUND

• 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.

  PMID: 21372203 BACKGROUND

• 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.

  PMID: 21358568 BACKGROUND

• 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.

  PMID: 21330450 BACKGROUND

• 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.

  PMID: 20628767 BACKGROUND

• 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.

  PMID: 20525194 BACKGROUND

• 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.

  PMID: 20064050 BACKGROUND

• 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.

  PMID: 19027342 BACKGROUND

• 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.

  PMID: 18689610 BACKGROUND

• 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.

  PMID: 18673077 BACKGROUND

• 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.

  PMID: 17178922 BACKGROUND

• 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.

  PMID: 16839800 BACKGROUND

• 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.

  PMID: 15928561 BACKGROUND

• 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.

  PMID: 15611489 BACKGROUND

• 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.

  PMID: 15125860 BACKGROUND

• 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.

  PMID: 14606342 BACKGROUND

• 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.

  PMID: 14524510 BACKGROUND

• 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.

  PMID: 12890435 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 8915066 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Therapeutics; Rehabilitation

Study Officials

• Mitchell C Selhorst, DPT

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator, Sports and Orthopedic Physical Therapy Department

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (3)