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

NCT ID: NCT04406753

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-07-01

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.

Conditions

Neck Pain; Cervical Spine Disease; Rotation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy + Exercise Group

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.

Group Type: EXPERIMENTAL

Manual therapy techniques in C0-1 and C2-3 with cervical exercise

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Cervical Exercise

Intervention Type: OTHER

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.

Interventions

Manual therapy techniques in C0-1 and C2-3 with cervical exercise

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

Cervical Exercise

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Jacobo Rodríguez-Sanz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Zaragoza

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jacobo Rodríguez-Sanz, PhD

Role: CONTACT

jacobors@unizar.es

+34636136789

Facility Contacts

Jacobo Rodríguez-Sanz, PhD

Role: primary

jacobors@unizar.es

+34636136789

Other Identifiers

N13/2020

Identifier Type: -

Identifier Source: org_study_id