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Indirect Approach of C0-1 and C2-3 Segments in Flexion-rotation Test

Primary Purpose

Neck Pain, Cervical Spine Disease, Rotation

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy techniques in C0-1 and C2-3 with cervical exercise
Cervical Exercise
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring manual therapy, neck pain, exercise, restriction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de ZaragozaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy + Exercise Group

Exercise Group

Arm Description

Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.

This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction. The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.

Outcomes

Primary Outcome Measures

Flexion-rotation test
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 33º

Secondary Outcome Measures

Neck pain intensity with Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Pain intensity during the flexion-rotation test with Numeric Pain Rating Scale
It will be recorded if the patient has pain during the flexion-rotation test
Cervical range of motion

Full Information

First Posted
May 20, 2020
Last Updated
May 22, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04406753
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Spine Disease, Rotation
Keywords
manual therapy, neck pain, exercise, restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy + Exercise Group
Arm Type
Experimental
Arm Description
Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction. The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.
Intervention Type
Other
Intervention Name(s)
Manual therapy techniques in C0-1 and C2-3 with cervical exercise
Intervention Description
Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.
Intervention Type
Other
Intervention Name(s)
Cervical Exercise
Intervention Description
This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction. The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.
Primary Outcome Measure Information:
Title
Flexion-rotation test
Description
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 33º
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Neck pain intensity with Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Pain intensity during the flexion-rotation test with Numeric Pain Rating Scale
Description
It will be recorded if the patient has pain during the flexion-rotation test
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Cervical range of motion
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobo Rodríguez-Sanz, PhD
Phone
+34636136789
Email
jacobors@unizar.es
Facility Information:
Facility Name
Universidad de Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobo Rodríguez-Sanz, PhD
Phone
+34636136789
Email
jacobors@unizar.es

12. IPD Sharing Statement

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Indirect Approach of C0-1 and C2-3 Segments in Flexion-rotation Test

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