NCT04406753

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

Status unknown NA Last updated 28 May 2020

What this trial tests

NA trial testing Manual therapy techniques in C0-1 and C2-3 with cervical exercise in Neck Pain in 48 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Universidad de Zaragoza
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	1 June 2020
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Neck Pain — all drugs for Neck Pain →
• Cervical Spine Disease — all drugs for Cervical Spine Disease →
• Rotation — all drugs for Rotation →

Sponsor

Universidad de Zaragoza — full company profile →

Who can join

Adults 18 to 90, any sex, with Neck Pain or Cervical Spine Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of the Manual Therapy Approach of Segments C0-1 and C2-3 in the Flexion-Rotation Test in Patients with Chronic Neck Pain: A Randomized Controlled Trial.
   Rodríguez-Sanz J, Malo-Urriés M, Lucha-López MO, Pérez-Bellmunt A, et al · · 2021 · cited 16× · PMID 33477316 · DOI 10.3390/ijerph18020753