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

Not Applicable

• Conditions: Neck Pain
• Interventions: 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

• Registration Number: NCT04054869
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-10
• Study First Posted: 2019-08-13
• Status Verified: 2019-11
• Study Start: 2019-11-07
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bio-mechanically correct manual therapy (received first) arm	Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints	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.
Bio-mechanically correct manual therapy (received first) arm	Bio-mechanically correct manual therapy at the cervical atlanto-axial joints	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.
Bio-mechanically incorrect manual therapy (received first) arm	Bio-mechanically correct manual therapy at the cervical atlanto-axial joints	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.
Bio-mechanically incorrect manual therapy (received first) arm	Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints	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.

Primary Outcome Measures

Name	Time	Method
intra-visit change in cervical active range of motion rotation	day 1: pre and post treatment change, day 3: pre and post treatment change	measured by standard goniometry

Secondary Outcome Measures

Name	Time	Method
inter-visit change in neck disability/function	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
intra-visit change in cervical pain at rest	day 1: pre and post treatment change, day 3: pre and post treatment change	measured by the numeric pain rating scale 0-10
intra-visit change in cervical pain during most restricted active rotation	day 1: pre and post treatment change, day 3: pre and post treatment change	measured by the numeric pain rating scale 0-10

Trial Locations

Locations (1)

Indiana University Health - West Hospital; 🇺🇸 Avon, Indiana, United States