Clinical trial NCT04054869: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Keywords: neck stiffness
manual therapy
joint mobilization
Lead sponsor: Andrews University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: each participant receives both treatments in randomized order
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: intra-visit change in cervical active range of motion rotation
timeFrame: day 1: pre and post treatment change, day 3: pre and post treatment change
Secondary outcomes:
measure: intra-visit change in cervical pain at rest
timeFrame: day 1: pre and post treatment change, day 3: pre and post treatment change
measure: inter-visit change in neck disability/function
timeFrame: change between day 1 and day 3, change between day 3 and day 5
measure: intra-visit change in cervical pain during most restricted active rotation
timeFrame: day 1: pre and post treatment change, day 3: pre and post treatment change
Other outcomes:
Locations:
city: Avon
country: United States
facility: Indiana University Health - West Hospital
state: Indiana
Study officials:
affiliation: Andrews University, Indiana University Health
name: Michael Williams, MPT
role: PRINCIPAL_INVESTIGATOR
References:
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