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

November 26, 2019 updated by: Michael J Williams, Andrews University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

    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)

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • joint mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1: pre and post treatment change, day 3: pre and post treatment change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
measured by Neck Disability Index (NDI) score, range 0-100% with 0%= no disability and 100% = fully disabled
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
measured by the numeric pain rating scale 0-10
day 1: pre and post treatment change, day 3: pre and post treatment change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews University

Investigators

  • Principal Investigator: Michael Williams, MPT, Andrews University, Indiana University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 4, 2019

First Submitted That Met QC Criteria

August 10, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 19-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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