Effects of C0-C1 Mobilization in the Neutral Position in Subjects With Upper Cervical Rotational Hypomobility

Upper Cervical Spine Rotational Hypomobility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404766
• Other study ID #: CP23/2012
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2015
• Last updated: March 30, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to cervical pain and headache. However, serious neurovascular adverse effects have been documented through direct treatment of C1-C2 segment. Although indirect treatment via adjacent segments and avoidance of end range of rotation and extension have been recommended for a safer and effective cervical treatment, there is no scientific evidence of the effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2 hypomobility.

Due to that, the investigators designed a randomized controlled trial to compare the short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2 hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the neutral cervical position can recover the C1-C2 rotational range of movement in subjects with upper cervical hypomobility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

• FRT with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)

• Indication of grade III mobilization in C0-C1 and C7-T1 segments

• Aged 18-66

• Signed informed consent

Exclusion Criteria:

• Contraindication to manual therapy and red flags according to Rushton et al. (2012)

• Pain presence at the beginning or during the study

• Cervical treatment during the last three months

• Inability to tolerate FRT

• Involvement in litigation or compensation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Upper Cervical Spine Rotational Hypomobility

Intervention

Other:
• C0-C1 dorsal glide manual mobilization

• C7-T1 ventral cranial glide manual mobilization

Locations

Country	Name	City	State
Spain	César Hidalgo	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline in Range of movement in Upper Cervical Spine	Flexion-rotation test measured by CROM device	1 hour after intervention	Yes
Secondary	Cervical range of movement in cardinal planes	Active cervical range of movement in sagittal, frontal and transversal planes measured by CROM device.	1 hour after intervention	Yes
Secondary	Upper cervical flexion and extension range of movement	Active upper cervical flexion and extension range of movement measured with CROM device	1 hour after intervention	Yes