Neck PainNCT04054869
Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization
A study testing Bio-mechanically correct manual therapy at the cervical atlanto-axial joints and Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints in people with Neck Pain, run by Andrews University at 1 site in United States.
Trial summary
Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Bio-mechanically correct manual therapy at the cervical atlanto-axial joints and Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to Oct 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or females between 18 and 80 years of age
- 25 percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness
Who cannot join
- cervical surgeries or injections in the past one year
- current manual or exercise treatment by another provider for neck pain
- cervical manipulation/mobilization/trauma in past 3 months
- cervical radicular or referred pain distal to the acromion
- upper extremity neurologic myotome weakness or constant dermatomal numbness
- pending litigation
Show all 9Show fewer
- signs of cervical myelopathy or vertebrobasilar artery insufficiency
- use of prescribed anticoagulants or documented blood clotting disorder
- alar or transverse ligament instability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Indiana University Health - West Hospital
Avon, Indiana, 46123
Michael Williams, MPT, 317-217-3070, mwilliams6@iuhealth.org
Nick Batuello, DPT, (317)217-3070, nbatuello@iuhealth.org
About this study
Official title: Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization to Improve Cervical Rotation, Improve Function and Reduce Pain.... Does it Matter?
Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.
Read the detailed description
Participants are recruited consecutively through referral from provider clinics or through self referral to physical therapy in the outpatient rehabilitation clinic at Indiana University Health West Hospital in Avon Indiana. After obtaining informed consent and meeting study criteria, participants will be randomized into either first receiving atlanto-axial joint mobilizations in a bio-mechanically correct or incorrect direction with respect to their loss of cervical rotation. Outcome measures will be completed both pre and post treatment. The participants will then be given self stretches at home to mimic the same intervention performed in the clinic three times per day. The participants will then return to the clinic in two or three days to receive the opposite treatment and opposite home program. Outcome data will again be collected both pre and post treatment. Participants will return for a final visit in two or three days and final outcome data will be collected and the participant will be offered continuation of physical therapy if neck symptoms still persist.
Planned Statistical Analysis:
- Descriptive statistics of subjects: age, gender, date of onset, Neck Disability Index, cervical active range of motion rotation, initial numeric pain rating at rest and rotating to the limited side
- Repeated measures ANOVA effect sizes for comparing differences between:
- Pre and post treatment comparing with-in treatment change for cervical range of motion rotation and numeric pain ratings on 1st and 2nd visits. Also comparing post treatment in cervical range of motion rotation and numeric pain ratings between 2nd and 3rd visits.
- Neck disability index change between 1st and 2nd visits and 2nd and 3rd visits
- Power calculation (actual achieved power)
- Conditions
- Neck Pain
- Being tested
- Bio-mechanically correct manual therapy at the cervical atlanto-axial joints, Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
- Keywords
- neck stiffness, manual therapy, joint mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-mechanically correct manual therapy at the cervical atlanto-axial jointsOther
Also called joint mobilization
Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments congruently to the direction of rotational loss.
Bio-mechanically in-correct manual therapy at the cervical atlanto-axial jointsOther
Also called joint mobilization
Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments in-congruently to the direction of rotational loss.
| Study group | Role | What they receive |
|---|---|---|
| Bio-mechanically correct manual therapy (received first) arm | Experimental | Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically correct direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired. Receives: Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints; Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints |
| Bio-mechanically incorrect manual therapy (received first) arm | Experimental | Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically incorrect direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired. Receives: Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints; Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-visit change in cervical active range of motion rotation
measured by standard goniometry
Measured: day 1: pre and post treatment change, day 3: pre and post treatment change
Secondary outcomes (3)
intra-visit change in cervical pain at rest
measured by the numeric pain rating scale 0-10
Measured: day 1: pre and post treatment change, day 3: pre and post treatment change
inter-visit change in neck disability/function
measured by Neck Disability Index (NDI) score, range 0-100% with 0%= no disability and 100% = fully disabled
Measured: change between day 1 and day 3, change between day 3 and day 5
intra-visit change in cervical pain during most restricted active rotation
measured by the numeric pain rating scale 0-10
Measured: day 1: pre and post treatment change, day 3: pre and post treatment change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start7 Nov 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- each participant receives both treatments in randomized order
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J Williams, Andrews University
- Investigators
- Michael Williams, MPT, Principal investigator, Andrews University, Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054869
- Sponsor's protocol ID
- IRB 19-089
- Status last verified
- Nov 2019
- First submitted
- 4 Aug 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bishop MD, Mintken PE, Bialosky JE, Cleland JA. Patient expectations of benefit from interventions for neck pain and resulting influence on outcomes. J Orthop Sports Phys Ther. 2013;43(7):457-65. doi: 10.2519/jospt.2013.4492. Epub 2013 Mar 18.
PubMed 23508341Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
PubMed 22851876Slaven EJ, Goode AP, Coronado RA, Poole C, Hegedus EJ. The relative effectiveness of segment specific level and non-specific level spinal joint mobilization on pain and range of motion: results of a systematic review and meta-analysis. J Man Manip Ther. 2013 Feb;21(1):7-17. doi: 10.1179/2042618612Y.0000000016.
PubMed 24421608Celenay ST, Akbayrak T, Kaya DO. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Feb;46(2):44-55. doi: 10.2519/jospt.2016.5979. Epub 2016 Jan 11.
PubMed 26755405van der Velde G, Yu H, Paulden M, Cote P, Varatharajan S, Shearer HM, Wong JJ, Randhawa K, Southerst D, Mior S, Sutton D, Jacobs C, Taylor-Vaisey A. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1582-1597. doi: 10.1016/j.spinee.2015.08.025. Epub 2015 Nov 26.
PubMed 26631759Schmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
PubMed 18316238Creighton D, Gruca M, Marsh D, Murphy N. A comparison of two non-thrust mobilization techniques applied to the C7 segment in patients with restricted and painful cervical rotation. J Man Manip Ther. 2014 Nov;22(4):206-12. doi: 10.1179/2042618614Y.0000000077.
PubMed 25395829Aquino RL, Caires PM, Furtado FC, Loureiro AV, Ferreira PH, Ferreira ML. Applying Joint Mobilization at Different Cervical Vertebral Levels does not Influence Immediate Pain Reduction in Patients with Chronic Neck Pain: A Randomized Clinical Trial. J Man Manip Ther. 2009;17(2):95-100. doi: 10.1179/106698109790824686.
PubMed 20046551Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
PubMed 28826164Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
PubMed 26852024Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
PubMed 21979312Youdas JW, Carey JR, Garrett TR. Reliability of measurements of cervical spine range of motion--comparison of three methods. Phys Ther. 1991 Feb;71(2):98-104; discussion 105-6. doi: 10.1093/ptj/71.2.98.
PubMed 1989013Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.
PubMed 18164333
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization to Improve Cervical Rotation, Improve Function and Reduce Pain.... Does it Matter?
- ClinicalTrials.gov ID
- NCT04054869
- Acronym / sponsor ID
- IRB 19-089
- Conditions
- Neck Pain
- Keywords
- neck stiffness, manual therapy, joint mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Andrews UniversityUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 Aug 2019 (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.
Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.
Detailed description
Participants are recruited consecutively through referral from provider clinics or through self referral to physical therapy in the outpatient rehabilitation clinic at Indiana University Health West Hospital in Avon Indiana. After obtaining informed consent and meeting study criteria, participants will be randomized into either first receiving atlanto-axial joint mobilizations in a bio-mechanically correct or incorrect direction with respect to their loss of cervical rotation. Outcome measures will be completed both pre and post treatment. The participants will then be given self stretches at home to mimic the same intervention performed in the clinic three times per day. The participants will then return to the clinic in two or three days to receive the opposite treatment and opposite home program. Outcome data will again be collected both pre and post treatment. Participants will return for a final visit in two or three days and final outcome data will be collected and the participant will be offered continuation of physical therapy if neck symptoms still persist.
Planned Statistical Analysis:
- Descriptive statistics of subjects: age, gender, date of onset, Neck Disability Index, cervical active range of motion rotation, initial numeric pain rating at rest and rotating to the limited side
- Repeated measures ANOVA effect sizes for comparing differences between:
- Pre and post treatment comparing with-in treatment change for cervical range of motion rotation and numeric pain ratings on 1st and 2nd visits. Also comparing post treatment in cervical range of motion rotation and numeric pain ratings between 2nd and 3rd visits.
- Neck disability index change between 1st and 2nd visits and 2nd and 3rd visits
- Power calculation (actual achieved power)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- each participant receives both treatments in randomized order
| Arm | Type | Receives |
|---|---|---|
| Bio-mechanically correct manual therapy (received first) arm | Experimental | Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints, Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial jointsParticipants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically correct direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired. |
| Bio-mechanically incorrect manual therapy (received first) arm | Experimental | Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints, Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial jointsParticipants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically incorrect direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- males or females between 18 and 80 years of age
- 25 percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness
Key exclusion criteria (9 listed)
- cervical surgeries or injections in the past one year
- current manual or exercise treatment by another provider for neck pain
- cervical manipulation/mobilization/trauma in past 3 months
- cervical radicular or referred pain distal to the acromion
- upper extremity neurologic myotome weakness or constant dermatomal numbness
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 |
|---|---|---|
| Bio-mechanically correct manual therapy at the cervical atlanto-axial jointsAlso: joint mobilizationParticipant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments congruently to the direction of rotational loss. | Other | Bio-mechanically correct manual therapy (received first) arm, Bio-mechanically incorrect manual therapy (received first) arm |
| Bio-mechanically in-correct manual therapy at the cervical atlanto-axial jointsAlso: joint mobilizationParticipant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments in-congruently to the direction of rotational loss. | Other | Bio-mechanically correct manual therapy (received first) arm, Bio-mechanically incorrect manual therapy (received first) arm |
Primary outcome
intra-visit change in cervical active range of motion rotation
Time frame: day 1: pre and post treatment change, day 3: pre and post treatment change
measured by standard goniometry
3 secondary outcomes
intra-visit change in cervical pain at rest
Time frame: day 1: pre and post treatment change, day 3: pre and post treatment change
inter-visit change in neck disability/function
Time frame: change between day 1 and day 3, change between day 3 and day 5
intra-visit change in cervical pain during most restricted active rotation
Time frame: day 1: pre and post treatment change, day 3: pre and post treatment change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 23508341Bishop MD, Mintken PE, Bialosky JE, Cleland JA. Patient expectations of benefit from interventions for neck pain and resulting influence on outcomes. J Orthop Sports Phys Ther. 2013;43(7):457-65. doi: 10.2519/jospt.2013.4492. Epub 2013 Mar 18.
- Background: PubMed 22851876Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
- Background: PubMed 24421608Slaven EJ, Goode AP, Coronado RA, Poole C, Hegedus EJ. The relative effectiveness of segment specific level and non-specific level spinal joint mobilization on pain and range of motion: results of a systematic review and meta-analysis. J Man Manip Ther. 2013 Feb;21(1):7-17. doi: 10.1179/2042618612Y.0000000016.
- Background: PubMed 26755405Celenay ST, Akbayrak T, Kaya DO. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Feb;46(2):44-55. doi: 10.2519/jospt.2016.5979. Epub 2016 Jan 11.
- Background: PubMed 26631759van der Velde G, Yu H, Paulden M, Cote P, Varatharajan S, Shearer HM, Wong JJ, Randhawa K, Southerst D, Mior S, Sutton D, Jacobs C, Taylor-Vaisey A. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1582-1597. doi: 10.1016/j.spinee.2015.08.025. Epub 2015 Nov 26.
- Background: PubMed 18316238Schmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
- Background: PubMed 25395829Creighton D, Gruca M, Marsh D, Murphy N. A comparison of two non-thrust mobilization techniques applied to the C7 segment in patients with restricted and painful cervical rotation. J Man Manip Ther. 2014 Nov;22(4):206-12. doi: 10.1179/2042618614Y.0000000077.
- Background: PubMed 20046551Aquino RL, Caires PM, Furtado FC, Loureiro AV, Ferreira PH, Ferreira ML. Applying Joint Mobilization at Different Cervical Vertebral Levels does not Influence Immediate Pain Reduction in Patients with Chronic Neck Pain: A Randomized Clinical Trial. J Man Manip Ther. 2009;17(2):95-100. doi: 10.1179/106698109790824686.
- Background: PubMed 28826164Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- Background: PubMed 26852024Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Background: PubMed 21979312Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
- Background: PubMed 1989013Youdas JW, Carey JR, Garrett TR. Reliability of measurements of cervical spine range of motion--comparison of three methods. Phys Ther. 1991 Feb;71(2):98-104; discussion 105-6. doi: 10.1093/ptj/71.2.98.
- Individual participant dataSharing planned: No
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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.
Michael Williams, MPT principal investigator
Andrews University, Indiana University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-mechanically correct manual therapy at the cervical atlanto-axial joints and Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints in people with Neck Pain, run by Andrews University at 1 site in United States.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Nov 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Williams, MPT ((317)757-9160, mwilliams6@iuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-visit change in cervical active range of motion rotation (time frame: day 1: pre and post treatment change, day 3: pre and post treatment change). 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 NCT04054869, which also lists 13 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 29 Nov 2019.