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Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bio-mechanically correct manual therapy at the cervical atlanto-axial joints
Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
Sponsored by
Andrews University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck stiffness, manual therapy, joint mobilization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • signs of cervical myelopathy or vertebrobasilar artery insufficiency
  • use of prescribed anticoagulants or documented blood clotting disorder
  • alar or transverse ligament instability

Sites / Locations

  • Indiana University Health - West HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bio-mechanically correct manual therapy (received first) arm

Bio-mechanically incorrect manual therapy (received first) arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

intra-visit change in cervical active range of motion rotation
measured by standard goniometry

Secondary Outcome Measures

intra-visit change in cervical pain at rest
measured by the numeric pain rating scale 0-10
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
intra-visit change in cervical pain during most restricted active rotation
measured by the numeric pain rating scale 0-10

Full Information

First Posted
August 4, 2019
Last Updated
November 26, 2019
Sponsor
Andrews University
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1. Study Identification

Unique Protocol Identification Number
NCT04054869
Brief Title
Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization
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?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andrews University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck stiffness, manual therapy, joint mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
each participant receives both treatments in randomized order
Masking
ParticipantOutcomes Assessor
Masking Description
participants and the outcomes assessor will be masked (blinded) as to the order in which each participant receives the interventions
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bio-mechanically correct manual therapy (received first) arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Bio-mechanically incorrect manual therapy (received first) arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bio-mechanically correct manual therapy at the cervical atlanto-axial joints
Other Intervention Name(s)
joint mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
Other Intervention Name(s)
joint mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
intra-visit change in cervical active range of motion rotation
Description
measured by standard goniometry
Time Frame
day 1: pre and post treatment change, day 3: pre and post treatment change
Secondary Outcome Measure Information:
Title
intra-visit change in cervical pain at rest
Description
measured by the numeric pain rating scale 0-10
Time Frame
day 1: pre and post treatment change, day 3: pre and post treatment change
Title
inter-visit change in neck disability/function
Description
measured by Neck Disability Index (NDI) score, range 0-100% with 0%= no disability and 100% = fully disabled
Time Frame
change between day 1 and day 3, change between day 3 and day 5
Title
intra-visit change in cervical pain during most restricted active rotation
Description
measured by the numeric pain rating scale 0-10
Time Frame
day 1: pre and post treatment change, day 3: pre and post treatment change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 signs of cervical myelopathy or vertebrobasilar artery insufficiency use of prescribed anticoagulants or documented blood clotting disorder alar or transverse ligament instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Williams, MPT
Phone
(317)757-9160
Email
mwilliams6@iuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Greg Almeter, DScPT
Phone
(269)471-6552
Email
almeter@andrews.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Williams, MPT
Organizational Affiliation
Andrews University, Indiana University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health - West Hospital
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Williams, MPT
Phone
317-217-3070
Email
mwilliams6@iuhealth.org
First Name & Middle Initial & Last Name & Degree
Nick Batuello, DPT
Phone
(317)217-3070
Email
nbatuello@iuhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23508341
Citation
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Results Reference
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PubMed Identifier
22851876
Citation
Boyles 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.
Results Reference
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PubMed Identifier
24421608
Citation
Slaven 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.
Results Reference
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PubMed Identifier
26755405
Citation
Celenay 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.
Results Reference
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PubMed Identifier
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Citation
van 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.
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PubMed Identifier
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Citation
Schmid 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.
Results Reference
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PubMed Identifier
25395829
Citation
Creighton 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.
Results Reference
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PubMed Identifier
20046551
Citation
Aquino 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.
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization

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