Chronic Neck PainNCT04347551
The Effects of Spinal Manipulation on Performance on Neck Pain Patients During a Fitts' Task
A study testing High velocity/low amplitude cervical spine manipulation in people with Chronic Neck Pain, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- High velocity/low amplitude cervical spine manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2021to 18 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Between the ages of 18 and 40
Show all 9Show fewer
- No neck pain for at least 3 months
- Palpable spinal segmental fixations at C1-7
- Normal or corrected-to-normal vision
Who cannot join
- 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
Show all 17Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Performance of Asymptomatic and Chronic Neck Pain Participants Pre- and Post-spinal Manipulation Using an Eye and Head Movement Fitts' Task
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.
Read the detailed 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.
- Conditions
- Chronic Neck Pain
- Being tested
- High velocity/low amplitude cervical spine manipulation
- Keywords
- Manipulation, Spinal, Fitts' Task, Motor Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity/low amplitude cervical spine manipulationOther
Also called Cervical manipulation, Neck manipulation, Cervical adjustment, Neck adjustment
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.
| Study group | Role | What they receive |
|---|---|---|
| Eye movement Fitts' task | Experimental | High velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants. Receives: Other: High velocity/low amplitude cervical spine manipulation |
| Head movement Fitts' task | Active comparator | High velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants. Receives: Other: High velocity/low amplitude cervical spine manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline saccade movement time immediately following cervical spine manipulation.
Change in head movement time
Head movement time (milliseconds) is the time required to move the cursor from the central circle to the target.
Measured: Change from baseline head movement time immediately following cervical spine manipulation.
Secondary outcomes (4)
Change in saccade peak velocity
Peak of the velocity amplitude (meters/second) in the horizontal movement direction
Measured: Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Change in time to peak saccade velocity
Measured as the time (milliseconds) from the onset of velocity to its peak amplitude
Measured: Change from baseline time to peak velocity immediately following cervical spine manipulation.
Change in head peak velocity
Measured as the peak of the velocity amplitude (meters/second) of the cursor moving in the horizontal plane
Measured: Change from baseline head peak velocity immediately following cervical spine manipulation.
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.
Measured: Change from baseline time to peak head velocity immediately following cervical spine manipulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start25 May 2021
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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 eye and head movement time, eye and head peak velocity, and time to peak eye and head velocity.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoff Gelley, University of Manitoba
- Investigators
- Geoff Gelley, DC, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347551
- Sponsor's protocol ID
- B2020:010
- Status last verified
- Sep 2021
- First submitted
- 8 Apr 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will be sharing processed and analyzed data. The results of this study will be prepared for dissemination first at relevant clinical and scientific conferences. Subsequently, this work will be submitted to a peer reviewed journal for consideration of publication. Datasets will be deposited in the University of Manitoba's Dataverse. The data collected during this study may be shared in an anonymized or de-identified form with academic journals for publication purposes or other researchers according to international guidelines. The data may also be stored by the academic journal under an open access policy in which case it may be used by other researchers for further data analysis and research purposes. Before publishing/sharing any data, it will be reviewed with the Research Ethics Board or oversight committee to ensure full compliance with privacy legislation.
Publications
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.
PubMed 24361109Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.
PubMed 15195039Fitts 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. doi: 10.1037//0096-3445.121.3.262. No abstract available.
PubMed 1402698Fitts PM, Radford BK. Information capacity of discrete motor responses under different cognitive sets. J Exp Psychol. 1966 Apr;71(4):475-82. doi: 10.1037/h0022970. No abstract available.
PubMed 5909070Flor 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. doi: 10.1016/s0304-3940(97)13441-3.
PubMed 9132689Fryer G, Morris T, Gibbons P. Paraspinal muscles and intervertebral dysfunction: part one. J Manipulative Physiol Ther. 2004 May;27(4):267-74. doi: 10.1016/j.jmpt.2004.02.006.
PubMed 15148466Gay 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.
PubMed 25284739Gelley 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.
PubMed 25458144George 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. doi: 10.1186/1471-2474-7-68.
PubMed 16911795Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort 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.
PubMed 20510644Gyer 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.
PubMed 31105036Haavik-Taylor H, Murphy B. Cervical spine manipulation alters sensorimotor integration: a somatosensory evoked potential study. Clin Neurophysiol. 2007 Feb;118(2):391-402. doi: 10.1016/j.clinph.2006.09.014. Epub 2006 Nov 29.
PubMed 17137836Haavik 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.
PubMed 21334540Haavik 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.
PubMed 22483612Haavik 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.
PubMed 20534312
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Performance of Asymptomatic and Chronic Neck Pain Participants Pre- and Post-spinal Manipulation Using an Eye and Head Movement Fitts' Task
- ClinicalTrials.gov ID
- NCT04347551
- Acronym / sponsor ID
- B2020:010
- Conditions
- Chronic Neck Pain
- Keywords
- Manipulation, Spinal, Fitts' Task, Motor Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 eye and head movement time, eye and head peak velocity, and time to peak eye and head velocity.
| Arm | Type | Receives |
|---|---|---|
| Eye movement Fitts' task | Experimental | Other: High velocity/low amplitude cervical spine manipulationHigh velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants. |
| Head movement Fitts' task | Active comparator | Other: High velocity/low amplitude cervical spine manipulationHigh velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High velocity/low amplitude cervical spine manipulationAlso: Cervical manipulation, Neck manipulation, Cervical adjustment, Neck adjustmentThe 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. | Other | Eye movement Fitts' task, Head movement Fitts' task |
Primary outcome
Change in eye (saccade) movement time
Time frame: Change from baseline saccade movement time immediately following cervical spine manipulation.
Eye (saccade) movement time (milliseconds), which is the time between saccade onset and offset while moving from central circle to the target.
Change in head movement time
Time frame: Change from baseline head movement time immediately following cervical spine manipulation.
Head movement time (milliseconds) is the time required to move the cursor from the central circle to the target.
4 secondary outcomes
Change in saccade peak velocity
Time frame: Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Change in time to peak saccade velocity
Time frame: Change from baseline time to peak velocity immediately following cervical spine manipulation.
Change in head peak velocity
Time frame: Change from baseline head peak velocity immediately following cervical spine manipulation.
Change in time to peak head velocity
Time frame: Change from baseline time to peak head velocity immediately following cervical spine manipulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 24361109Bialosky 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.
- Background: PubMed 15195039Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.
- Background: PubMed 1402698Fitts 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. doi: 10.1037//0096-3445.121.3.262. No abstract available.
- Background: PubMed 5909070Fitts PM, Radford BK. Information capacity of discrete motor responses under different cognitive sets. J Exp Psychol. 1966 Apr;71(4):475-82. doi: 10.1037/h0022970. No abstract available.
- Background: PubMed 9132689Flor 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. doi: 10.1016/s0304-3940(97)13441-3.
- Background: PubMed 15148466Fryer G, Morris T, Gibbons P. Paraspinal muscles and intervertebral dysfunction: part one. J Manipulative Physiol Ther. 2004 May;27(4):267-74. doi: 10.1016/j.jmpt.2004.02.006.
- Background: PubMed 25284739Gay 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.
- Background: PubMed 25458144Gelley 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.
- Background: PubMed 16911795George 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. doi: 10.1186/1471-2474-7-68.
- Background: PubMed 20510644Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort 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.
- Background: PubMed 31105036Gyer 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.
- Background: PubMed 17137836Haavik-Taylor H, Murphy B. Cervical spine manipulation alters sensorimotor integration: a somatosensory evoked potential study. Clin Neurophysiol. 2007 Feb;118(2):391-402. doi: 10.1016/j.clinph.2006.09.014. Epub 2006 Nov 29.
- Individual participant dataSharing planned: Yes. I will be sharing processed and analyzed data. The results of this study will be prepared for dissemination first at relevant clinical and scientific conferences. Subsequently, this work will be submitted to a peer reviewed journal for consideration of publication. Datasets will be deposited in the University of Manitoba's Dataverse. The data collected during this study may be shared in an anonymized or de-identified form with academic journals for publication purposes or other researchers according to international guidelines. The data may also be stored by the academic journal under an open access policy in which case it may be used by other researchers for further data analysis and research purposes. Before publishing/sharing any data, it will be reviewed with the Research Ethics Board or oversight committee to ensure full compliance with privacy legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Gelley, DC, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High velocity/low amplitude cervical spine manipulation in people with Chronic Neck Pain, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eye (saccade) movement time (time frame: Change from baseline saccade movement time immediately following cervical spine manipulation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347551, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.