Clinical trial NCT04406753: Indirect Approach of C0-1 and C2-3 Segments in Flexion-rotation Test
Official title: Is it Possible to Improve the Flexion-rotation Test With an Indirect Approach of C0-1 and C2-3 Segments? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Cervical Spine Disease
Rotation
Keywords: manual therapy
neck pain
exercise
restriction
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Restrictions on upper cervical spine are associated with cervical pain. The vast majority of upper cervical spine rotation occurs at the C1-2 segment. Flexion-rotation test is a valid measure that predominantly measures rotation in C1-2 segment, however upper cervical spine rotation also implies C0-1 and C2-3 due to ligament anatomy. Restriction in flexion-rotation may be due to direct restriction in C1-2, but also to a premature tightening of the alar ligament as a result of lack of movement in C0-1 or C2-3.

The objective is to compare the effect of a 20-minutes single cervical exercise session with or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test in patients with chronic neck pain and positive flexion-rotation test.

To carry out the objective, the following will be designed a randomized controlled assessor-blind clinical trial with primary healthcare patients.

This population will be patients with chronic neck pain and positive flexion-rotation test. These patients will be assigned in manual therapy + exercise group or in exercise group.

Exercise will be focused on deep anterior cervical muscles. Manual therapy will combine techniques in C0-1 and C2-3 with this exercise. Flexion-rotation test, neck pain intensity, pain intensity during the flexion-rotation test and cervical range of motion will be measured before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* A medical diagnosis of chronic neck pain with more than 3 months of evolution.
* A positive result in the flexion-rotation test (less than 33º or a difference of 10º or more between the two rotations).
* Being over 18 years old.
* Having signed the informed consent.

Exclusion Criteria:

* Contraindications for manual therapy or exercise.
* Having participated in exercise or manual therapy programs in the last three months.
* Presenting warning signs or having suffered a relevant neck trauma.
* An inability to maintain supine position.
* The use of pacemakers (the magnets in the CROM device could alter their signal)
* An inability to perform flexion-rotation test
* Language difficulties.
* Pending litigation or lawsuits.

Primary outcomes:
measure: Flexion-rotation test
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes:
measure: Neck pain intensity with Numeric Pain Rating Scale
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
measure: Pain intensity during the flexion-rotation test with Numeric Pain Rating Scale
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
measure: Cervical range of motion
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
References: