Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
12 participants
OBSERVATIONAL
2024-09-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low back pain group
Participants currently experiencing low back pain will have small accelerometers taped along spine, Ultrasound (US) Clinician will place an US transducer at the right L4/L5 Z joint. Participants will complete a range of motions while accelerometers are recording back sounds. Subsequently, they will receive a chiropractic adjustment, then repeat the range of motions
Range of motion with spinal adjustment
With accelerometers affixed to spine recording vibrations, the participants complete range of motion. After completing, they receive a low back spinal adjustment and repeat range of motion
Healthy group
Participants without low back pain will have small accelerometers taped along spine. Ultrasound (US) Clinician will place a US transducer at the right L4/L5 Z joint. Participants will perform a range of motions while accelerometers are recording back sounds. Subsequently, they will receive a chiropractic adjustment, then repeat the range of motions
Range of motion with spinal adjustment
With accelerometers affixed to spine recording vibrations, the participants complete range of motion. After completing, they receive a low back spinal adjustment and repeat range of motion
Interventions
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Range of motion with spinal adjustment
With accelerometers affixed to spine recording vibrations, the participants complete range of motion. After completing, they receive a low back spinal adjustment and repeat range of motion
Eligibility Criteria
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Inclusion Criteria
* 30 to 75 years of age
* No previous history of LBP lasting for more than two weeks, or no more than three episodes of back pain of brief duration (one week) in any given year (to recruit healthy subjects with no history, or a minimal history, of LBP).
* No presence of current LBP
* Female with a BMI of 28 or less; Male with a BMI of 30 or less.
LBP Subjects Criteria (n=6):
* 30 to 75 years of age
* Current LBP of at least one-week (7 days) duration
* Female with a BMI of 28 or less; Male with a BMI of 30 or less.
* Presence of Current LBP
* Prior spinal surgery
* Presence of current spinal fracture, tumor, infection, or scoliosis of greater than 5 degrees (Cobb's angle, scoliosis decreases ability to place the accelerometers); or other known significant pathology
* Known allergies to latex or adhesives (including Band-Aids) applied to the skin (accelerometers are taped to the skin)
* BMI over 30 for males; BMI over 28 for females (subject will be weighed at exam)
* Pregnancy (because of unique biomechanical patterns and changes in the ranges of motion that occur during pregnancy)
* Positive findings on any of the orthopedic or neurological tests listed on exam form; (because these subjects will be assessed as healthy individuals, indication of somatic pathology or neurological deficit are exclusionary criteria)
* Decreased range of motion (as measured with a goniometer) of the lumbar region (recording during flexion and extension ranges of motion are conducted in the study; consequently a full range of motion is necessary for the healthy subjects). The following ranges will be exclusionary: Flexion: \< 40º (normal = 60º); Extension: \< 10º (normal = 20º);
* Pain or discomfort during set-up for lumbar side-posture spinal manipulation (SMT) or during lumbar SMT given at the conclusion of the examination (the study assesses changes following SMT, consequently ability to tolerate SMT is important)
* Contraindication to manipulative treatment
LBP Subjects:
* Under 30 or over 75 years of age
* Absence of Current LBP of at least one-week (7 days) duration
* BMI over 30 for males; BMI over 28 for females (subject will be weighed at exam)
* Known allergies to latex or adhesives (including Band Aids) applied to the skin (accelerometers are taped to the skin)
* Pregnancy (because of unique biomechanical patterns and changes in the ranges of motion that occur during pregnancy)
* Pain radiating below the knee
* Presence of current spinal fracture, tumor, infection, or scoliosis of greater than 5 degrees (Cobb's angle, scoliosis decreases ability to place the accelerometers); or other known significant pathology
* Prior spinal surgery
* Negative findings on all of the orthopedic or neurological tests listed on exam form
* Contraindication to manipulative treatment
Exclusion Criteria
* Under 30 or over 75 years of age
30 Years
75 Years
ALL
Yes
Sponsors
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Yale University
OTHER
National University of Health Sciences
OTHER
Responsible Party
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Gregory D. Cramer
Professor and Dean of Research
Principal Investigators
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Gregory Cramer, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Health Sciences
Gregory Roytman, DC
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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National University of Health Sciences
Lombard, Illinois, United States
National University of Health Science
Lombard, Illinois, United States
Countries
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References
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Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
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.
Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
Schneider M, Haas M, Glick R, Stevans J, Landsittel D. Comparison of spinal manipulation methods and usual medical care for acute and subacute low back pain: a randomized clinical trial. Spine (Phila Pa 1976). 2015 Feb 15;40(4):209-17. doi: 10.1097/BRS.0000000000000724.
Fritz JM, Kim J, Dorius J. Importance of the type of provider seen to begin health care for a new episode low back pain: associations with future utilization and costs. J Eval Clin Pract. 2016 Apr;22(2):247-52. doi: 10.1111/jep.12464. Epub 2015 Sep 29.
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Int J Ther Massage Bodywork. 2015 Sep 1;8(3):16-33. doi: 10.3822/ijtmb.v8i3.295. eCollection 2015 Sep.
Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low-back pain. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD008880. doi: 10.1002/14651858.CD008880.pub2.
Deyo RA, Bryan M, Comstock BA, Turner JA, Heagerty P, Friedly J, Avins AL, Nedeljkovic SS, Nerenz DR, Jarvik JG. Trajectories of symptoms and function in older adults with low back disorders. Spine (Phila Pa 1976). 2015 Sep 1;40(17):1352-62. doi: 10.1097/BRS.0000000000000975.
Brennan GP, Fritz JM, Hunter SJ, Thackeray A, Delitto A, Erhard RE. Identifying subgroups of patients with acute/subacute "nonspecific" low back pain: results of a randomized clinical trial. Spine (Phila Pa 1976). 2006 Mar 15;31(6):623-31. doi: 10.1097/01.brs.0000202807.72292.a8.
Cramer GD, Ross JK, Raju PK, Cambron JA, Dexheimer JM, Bora P, McKinnis R, Selby S, Habeck AR. Distribution of cavitations as identified with accelerometry during lumbar spinal manipulation. J Manipulative Physiol Ther. 2011 Nov;34(9):572-83. doi: 10.1016/j.jmpt.2011.05.015. Epub 2011 Jul 18.
Cramer GD, Ross K, Pocius J, Cantu JA, Laptook E, Fergus M, Gregerson D, Selby S, Raju PK. Evaluating the relationship among cavitation, zygapophyseal joint gapping, and spinal manipulation: an exploratory case series. J Manipulative Physiol Ther. 2011 Jan;34(1):2-14. doi: 10.1016/j.jmpt.2010.11.008.
Cramer GD, Budavich M, Bora P, Ross K. A Feasibility Study to Assess Vibration and Sound From Zygapophyseal Joints During Motion Before and After Spinal Manipulation. J Manipulative Physiol Ther. 2017 Mar-Apr;40(3):187-200. doi: 10.1016/j.jmpt.2017.01.003. Epub 2017 Mar 6.
Cramer GD, Ross K, Raju PK, Cambron J, Cantu JA, Bora P, Dexheimer JM, McKinnis R, Habeck AR, Selby S, Pocius JD, Gregerson D. Quantification of cavitation and gapping of lumbar zygapophyseal joints during spinal manipulative therapy. J Manipulative Physiol Ther. 2012 Oct;35(8):614-21. doi: 10.1016/j.jmpt.2012.06.007. Epub 2012 Aug 14.
Lascelles BD, Dong YH, Marcellin-Little DJ, Thomson A, Wheeler S, Correa M. Relationship of orthopedic examination, goniometric measurements, and radiographic signs of degenerative joint disease in cats. BMC Vet Res. 2012 Jan 27;8:10. doi: 10.1186/1746-6148-8-10.
Abhishek A, Doherty M. Diagnosis and clinical presentation of osteoarthritis. Rheum Dis Clin North Am. 2013 Feb;39(1):45-66. doi: 10.1016/j.rdc.2012.10.007.
Robertson CJ. Joint crepitus--are we failing our patients? Physiother Res Int. 2010 Dec;15(4):185-8. doi: 10.1002/pri.492. Epub 2010 Oct 28. No abstract available.
Henderson CN, Cramer GD, Zhang Q, DeVocht JW, Fournier JT. Introducing the external link model for studying spine fixation and misalignment: part 2, Biomechanical features. J Manipulative Physiol Ther. 2007 May;30(4):279-94. doi: 10.1016/j.jmpt.2007.03.002.
Cramer GD, Henderson CN, Little JW, Daley C, Grieve TJ. Zygapophyseal joint adhesions after induced hypomobility. J Manipulative Physiol Ther. 2010 Sep;33(7):508-18. doi: 10.1016/j.jmpt.2010.08.002.
Roytman G, Faydenko J, Budavich M, Pocius JD, Cramer G. Automated Vibration and Acoustic Crepitus Sensing in Humans. J. Tribol. Sept 2023, 145 (9)
Other Identifiers
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H2101/H2302
Identifier Type: -
Identifier Source: org_study_id