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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347551
Other study ID # B2020:010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2021
Est. completion date August 18, 2021

Study information

Verified date September 2021
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to quantify motor performance, this study will use an eye movement Fitts' task to examine the effects of cervical spine manipulation on participants with chronic neck pain and the subsequent changes to saccade movement time. This study will also include a head movement Fitts' task which has previously reported a reduction in head movement time in chronic neck pain participants after cervical spine manipulation. This is an observational within-subjects design that involves a pre/post cervical spine manipulation intervention on participants (n=20) with chronic neck pain and asymptomatic controls (n=20). All participants will complete an eye movement and head movement Fitts' task before and after cervical spine manipulation to identify any changes in saccade and head movement time, saccade and head peak velocity, and time to peak saccade and head velocity.


Description:

The purpose of this study is to measure the effects of cervical spine manipulation on the motor performance of participants with and without chronic neck pain. The objective of this pre/post design study is to apply spinal manipulation of the cervical spine to participants with chronic neck pain and participants who are asymptomatic for neck pain, and to measure the subsequent changes of movement time of the eyes during an eye movement Fitts' task using eye-tracker technology. This study will also include a head movement Fitts' task, which has been previously shown to identify a reduction in head movement time in participants after receiving cervical spine manipulation. The head movement task, which has a biomechanical basis, will serve as a comparator to the eye movement task, which has a neurophysiologic basis. Changes in head and eye movement time are both measures of motor performance. The hypothesis for the eye movement Fitts' task, is that the eye movement time will be increase with larger distances between targets and will not be affected by changes in target width. It is anticipated that the eye movement time will reduce in the neck pain group following spinal manipulation in comparison to the asymptomatic group. We hypothesize that during the head movement task, symptomatic participants will experience a decrease in head movement time as compared to the asymptomatic group after spinal manipulation. We further hypothesize that head movement time will be increase with larger target distances and smaller target widths.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 18, 2021
Est. primary completion date August 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Participants with neck pain: Inclusion criteria - Between the ages of 18 and 40 - Neck pain for at least 3 months - Palpable spinal segmental fixations at C1-7 - Neck pain must be reproducible by neck movements and/or provocative - Normal or corrected-to-normal vision Exclusion criteria - Contraindications to spinal manipulation - Can't be calibrated during the eye movement Fitts task (excluded from eye movement test only) - Progressive neurologic deficits - Cervical spine trauma or surgery - Infection, tumor, osteoporosis, inflammatory spondyloarthropathy, spinal fracture, and a history of vestibular/inner ear dysfunction - Diagnosed with an autonomic disorder such as Horner's syndrome - Any current ocular and/or retinal disease, Diabetes, a history of head trauma - Currently using opioids, recreational drugs or have a history of substance abuse Asymptomatic participants: Inclusion criteria - Between the ages of 18 and 40 - No neck pain for at least 3 months - Palpable spinal segmental fixations at C1-7 - Normal or corrected-to-normal vision Exclusion criteria - Contraindications to spinal manipulation - Can't be calibrated during the eye movement Fitts task (excluded from eye movement test only) - Progressive neurologic deficits - Cervical spine trauma or surgery - Infection, tumor, osteoporosis, inflammatory spondyloarthropathy, spinal fracture, and a history of vestibular/inner ear dysfunction - Diagnosed with an autonomic disorder such as Horner's syndrome - Any current ocular and/or retinal disease, Diabetes, a history of head trauma - Currently using opioids, recreational drugs or have a history of substance abuse

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High velocity/low amplitude cervical spine manipulation
The participants will receive a single cervical spine rotary manipulation to the previously identified palpable cervical segmental fixation. During the performance of the manipulation, the supine participant will rest their arms at the sides of their body. Next, the index finger of the chiropractor's contact hand will be placed on the lamina of the restricted cervical segment. The chiropractor will then rotate the participant's head contralaterally until the barrier of the cervical segments volitional end range is reached. The chiropractor's other hand will be placed behind the participant's head to induce gentle neck rotation contralateral to the chiropractor's thrusting hand. The chiropractor will deliver a manual thrust, with the thrust vector directed towards the participant's opposite eye.

Locations

Country Name City State
Canada Gelley Chiropractic Office Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (30)

Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27. — View Citation

Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. Review. — View Citation

Fitts PM, Radford BK. Information capacity of discrete motor responses under different cognitive sets. J Exp Psychol. 1966 Apr;71(4):475-82. — View Citation

Fitts PM. The information capacity of the human motor system in controlling the amplitude of movement. 1954. J Exp Psychol Gen. 1992 Sep;121(3):262-9. — View Citation

Flor H, Braun C, Elbert T, Birbaumer N. Extensive reorganization of primary somatosensory cortex in chronic back pain patients. Neurosci Lett. 1997 Mar 7;224(1):5-8. — View Citation

Fryer G, Morris T, Gibbons P. Paraspinal muscles and intervertebral dysfunction: part one. J Manipulative Physiol Ther. 2004 May;27(4):267-74. Review. — View Citation

Gay CW, Robinson ME, George SZ, Perlstein WM, Bishop MD. Immediate changes after manual therapy in resting-state functional connectivity as measured by functional magnetic resonance imaging in participants with induced low back pain. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):614-27. doi: 10.1016/j.jmpt.2014.09.001. Epub 2014 Oct 3. — View Citation

Gelley GM, Passmore SR, MacNeil BJ. Acceleration of clinician hand movements during spinal manipulative therapy. Man Ther. 2015 Apr;20(2):342-8. doi: 10.1016/j.math.2014.10.010. Epub 2014 Oct 31. — View Citation

George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. — View Citation

Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Brønfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26. Review. — View Citation

Gyer G, Michael J, Inklebarger J, Tedla JS. Spinal manipulation therapy: Is it all about the brain? A current review of the neurophysiological effects of manipulation. J Integr Med. 2019 Sep;17(5):328-337. doi: 10.1016/j.joim.2019.05.004. Epub 2019 May 9. Review. — View Citation

Haavik H, Murphy B. Subclinical neck pain and the effects of cervical manipulation on elbow joint position sense. J Manipulative Physiol Ther. 2011 Feb;34(2):88-97. doi: 10.1016/j.jmpt.2010.12.009. — View Citation

Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6. Review. — View Citation

Haavik Taylor H, Murphy B. The effects of spinal manipulation on central integration of dual somatosensory input observed after motor training: a crossover study. J Manipulative Physiol Ther. 2010 May;33(4):261-72. doi: 10.1016/j.jmpt.2010.03.004. — View Citation

Haavik-Taylor H, Murphy B. Cervical spine manipulation alters sensorimotor integration: a somatosensory evoked potential study. Clin Neurophysiol. 2007 Feb;118(2):391-402. Epub 2006 Nov 29. — View Citation

Haneline MT, Cooperstein R, Young M, Birkeland K. Spinal motion palpation: a comparison of studies that assessed intersegmental end feel vs excursion. J Manipulative Physiol Ther. 2008 Oct;31(8):616-26. doi: 10.1016/j.jmpt.2008.09.007. Review. — View Citation

Herzog W. The biomechanics of spinal manipulation. J Bodyw Mov Ther. 2010 Jul;14(3):280-6. doi: 10.1016/j.jbmt.2010.03.004. Review. — View Citation

Lersa LB, Stinear CM, Lersa RA. The relationship between spinal dysfunction and reaction time measures. J Manipulative Physiol Ther. 2005 Sep;28(7):502-7. — View Citation

Marchand AA, Cantin V, Murphy B, Stern P, Descarreaux M. Is performance in goal oriented head movements altered in patients with tension type headache? BMC Musculoskelet Disord. 2014 May 26;15:179. doi: 10.1186/1471-2474-15-179. — View Citation

Passmore SR, Burke JR, Good C, Lyons JL, Dunn AS. Spinal manipulation impacts cervical spine movement and fitts' task performance: a single-blind randomized before-after trial. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):189-92. doi: 10.1016/j.jmpt.2010.01.007. — View Citation

Passmore SR, Descarreaux M. Performance based objective outcome measures and spinal manipulation. J Electromyogr Kinesiol. 2012 Oct;22(5):697-707. doi: 10.1016/j.jelekin.2012.02.005. Epub 2012 Mar 8. Review. — View Citation

Pickar JG, Bolton PS. Spinal manipulative therapy and somatosensory activation. J Electromyogr Kinesiol. 2012 Oct;22(5):785-94. doi: 10.1016/j.jelekin.2012.01.015. Epub 2012 Feb 19. Review. — View Citation

Pickar JG, Wheeler JD. Response of muscle proprioceptors to spinal manipulative-like loads in the anesthetized cat. J Manipulative Physiol Ther. 2001 Jan;24(1):2-11. — View Citation

Reed WR, Cranston JT, Onifer SM, Little JW, Sozio RS. Decreased spontaneous activity and altered evoked nociceptive response of rat thalamic submedius neurons to lumbar vertebra thrust. Exp Brain Res. 2017 Sep;235(9):2883-2892. doi: 10.1007/s00221-017-5013-5. Epub 2017 Jul 7. — View Citation

Reed WR, Liebschner MA, Sozio RS, Pickar JG, Gudavalli MR. Neural Response During a Mechanically Assisted Spinal Manipulation in an Animal Model: A Pilot Study. J Nov Physiother Phys Rehabil. 2015 Sep;2(2):20-27. Epub 2015 Apr 6. — View Citation

Reed WR, Long CR, Kawchuk GN, Pickar JG. Neural responses to the mechanical parameters of a high-velocity, low-amplitude spinal manipulation: effect of preload parameters. J Manipulative Physiol Ther. 2014 Feb;37(2):68-78. doi: 10.1016/j.jmpt.2013.12.004. Epub 2014 Jan 3. — View Citation

Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126. — View Citation

Smith DL, Dainoff MJ, Smith JP. The effect of chiropractic adjustments on movement time: a pilot study using Fitts Law. J Manipulative Physiol Ther. 2006 May;29(4):257-66. — View Citation

Stochkendahl MJ, Christensen HW, Hartvigsen J, Vach W, Haas M, Hestbaek L, Adams A, Bronfort G. Manual examination of the spine: a systematic critical literature review of reproducibility. J Manipulative Physiol Ther. 2006 Jul-Aug;29(6):475-85, 485.e1-10. Review. — View Citation

Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. Epub 2007 Aug 16. Review. — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change in Visual analog scale (VAS) score 100 mm visual analog scale (VAS) to score their pain intensity Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.
Other The Neck Disability Index (NDI) score To quantify neck disability related to work and physical activity. Baseline prior to cervical spine manipulation
Primary Change in eye (saccade) movement time Eye (saccade) movement time (milliseconds), which is the time between saccade onset and offset while moving from central circle to the target. Change from baseline saccade movement time immediately following cervical spine manipulation.
Primary Change in head movement time Head movement time (milliseconds) is the time required to move the cursor from the central circle to the target. Change from baseline head movement time immediately following cervical spine manipulation.
Secondary Change in saccade peak velocity Peak of the velocity amplitude (meters/second) in the horizontal movement direction Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Secondary Change in time to peak saccade velocity Measured as the time (milliseconds) from the onset of velocity to its peak amplitude Change from baseline time to peak velocity immediately following cervical spine manipulation.
Secondary Change in head peak velocity Measured as the peak of the velocity amplitude (meters/second) of the cursor moving in the horizontal plane Change from baseline head peak velocity immediately following cervical spine manipulation.
Secondary Change in time to peak head velocity The time (milliseconds) to peak velocity will be measured as the time from the onset of velocity to its peak amplitude. Change from baseline time to peak head velocity immediately following cervical spine manipulation.
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