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OpenTrials
Completed

NCT Number: NCT02404766

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.

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Key information

Conditions

Upper Cervical Spine Rotational Hypomobility

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

César Hidalgo

Zaragoza, Aragon, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C0-C1 dorsal glide manual mobilization

Other

C7-T1 ventral cranial glide manual mobilization

Other

Primary outcomes

  1. Change in baseline in Range of movement in Upper Cervical Spine

    Time frame: 1 hour after intervention

    Flexion-rotation test measured by CROM device

Secondary outcomes

  1. Cervical range of movement in cardinal planes

    Time frame: 1 hour after intervention

    Active cervical range of movement in sagittal, frontal and transversal planes measured by CROM device.

  2. Upper cervical flexion and extension range of movement

    Time frame: 1 hour after intervention

    Active upper cervical flexion and extension range of movement measured with CROM device

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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