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

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ClinicalTrials.gov Identifier: NCT04054869
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Michael J Williams, Andrews University

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.

Condition or disease Intervention/treatment Phase
Neck Pain 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 Not Applicable

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
  • Paired/dependent t-test, 95% confidence intervals and effect sizes for comparing differences between:

    1. 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.
    2. Neck disability index change between 1st and 2nd visits and 2nd and 3rd visits
  • Power calculation (actual achieved power)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: each participant receives both treatments in randomized order
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participants and the outcomes assessor will be masked (blinded) as to the order in which each participant receives the interventions
Primary Purpose: Treatment
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?
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bio-mechanically correct manual therapy (received first) arm
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.
Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints
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.
Other Name: joint mobilization

Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
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.
Other Name: joint mobilization

Experimental: Bio-mechanically incorrect manual therapy (received first) arm
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.
Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints
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.
Other Name: joint mobilization

Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints
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.
Other Name: joint mobilization




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. intra-visit change in cervical pain at rest [ Time Frame: day 1: pre and post treatment change, day 3: pre and post treatment change ]
    measured by the numeric pain rating scale 0-10

  2. inter-visit change in neck disability/function [ Time Frame: change between day 1 and day 3, change between day 3 and day 5 ]
    measured by Neck Disability Index (NDI) score, range 0-100% with 0%= no disability and 100% = fully disabled

  3. 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 ]
    measured by the numeric pain rating scale 0-10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054869


Contacts
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Contact: Michael Williams, MPT (317)757-9160 mwilliams6@iuhealth.org
Contact: Greg Almeter, DScPT (269)471-6552 almeter@andrews.edu

Locations
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United States, Indiana
Indiana University Health - West Hospital Not yet recruiting
Avon, Indiana, United States, 46123
Contact: Michael Williams, MPT    317-217-3070    mwilliams6@iuhealth.org   
Contact: Nick Batuello, DPT    (317)217-3070    nbatuello@iuhealth.org   
Sponsors and Collaborators
Andrews University
Investigators
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Principal Investigator: Michael Williams, MPT Andrews University, Indiana University Health

Publications:

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Responsible Party: Michael J Williams, Physical Therapist, Andrews University
ClinicalTrials.gov Identifier: NCT04054869     History of Changes
Other Study ID Numbers: IRB 19-089
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael J Williams, Andrews University:
neck stiffness
manual therapy
joint mobilization
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms