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

Low Back Pain Clinical Trial

Official title:

Lumbar Manipulation and Exercise for the Treatment of Acute Low Back Pain in Adolescents: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111278
• Other study ID #: IRB11-00262
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: December 22, 2014
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Lumbar Manipulation
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.
• Sham Manipulation
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.
• Physical Therapy
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital Sports and Ortho PT East Broad	Columbus	Ohio
United States	Nationwide Children's Hospital Sports and Ortho PT Ortho Center	Columbus	Ohio
United States	Nationwide Children's Hospital Sports and Ortho PT Westerville	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. Review. — View 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. — View 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. — View 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. Epub 2006 Jul 12. — View 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. — View 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. — View 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. — View Citation

Delitto A, George SZ, Van Dillen LR, 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.2012.0301. Epub 2012 Mar 30. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

McNeely ML, Torrance G, Magee DJ. A systematic review of physiotherapy for spondylolysis and spondylolisthesis. Man Ther. 2003 May;8(2):80-91. Review. — View 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. — View Citation

O'Neal ML. The pediatric spine: anatomical and dynamic considerations preceding manipulation. Compr Ther. 2003 Summer-Fall;29(2-3):124-9. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Dec 18. Review. Erratum in: Pediatrics. 2007 Jul;120(1):251. Pediatrics. 2007 Apr;119(4):867. — View 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence of low back pain	Patients will be asked if they have had significant pain or a recurrence of pain in the low back since therapy has ended. Yes or No response from the patient.	6 months	No
Other	Sought further treatment	Patient will be asked if they sought further treatment for their low back pain after 4 weeks of physical therapy ended.	6 months	No
Primary	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	No
Secondary	Global Rating of Change scale	The Global Rating of Change scale is a 15-point Likert type scale (-7 to +7). A score of 0 represents no change from initial injury, +7 represents a great deal better, and -7 represents a great deal worse.	1 week, and 4 weeks	No
Secondary	Change in Numeric Pain Rating Scale	The Numeric Pain Rating Scale is an 11-point pain-rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) to assess current pain intensity and the best and worst level of pain during the last 24 hours. An average of the 3 ratings will be used.	Initial Evaluation, 1 week, 4 weeks, and 6 month	No