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

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.

Study Overview

• Status: Completed
• Conditions: Upper Cervical Spine Rotational Hypomobility
• Intervention / Treatment: Other: C0-C1 dorsal glide manual mobilization; Other: C7-T1 ventral cranial glide manual mobilization

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • César Hidalgo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; C0-C1 dorsal glide mobilization in the cervical neutral position.	Other: C0-C1 dorsal glide manual mobilization
Experimental: Intervention group 2; C7-T1 ventral cranial glide mobilization in the cervical neutral position	Other: C7-T1 ventral cranial glide manual mobilization
No Intervention: Control group; Not receiving any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline in Range of movement in Upper Cervical Spine	Flexion-rotation test measured by CROM device	1 hour after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: manual therapy; cervical; range of movement
• Other Study ID Numbers: CP23/2012