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Completed

NCT Number: NCT02645630

Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability, widespread pressure pain sensitivity, and cervicokinethesia in patients with mechanical neck pain.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

About this study

Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients with mechanical neck pain. Patients will receive cervical spine manipulation in either right or left side of the neck and will be assessed on pain intensity, neck-related disability, widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the allocation group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.

Exclusion criteria

  • any contraindication to manipulation, e.g., positive extension-rotation test;
  • whiplash injury;
  • previous cervical surgery;
  • cervical radiculopathy or myelopathy;
  • diagnosis of fibromyalgia syndrome;
  • having undergone spinal manipulative therapy in the previous 6 months;
  • less than 18 or greater than 65 years of age.

Treatment and study plan

Right Cervical Manipulation

Other

We will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending.

Left Cervical Manipulation

Other

We will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending.

Sham Cervical Manipulation

Other

The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust

Primary outcomes

  1. Changes in cervical kinesthetic sense before and after the intervention

    Time frame: Baseline and 15 minutes after the intervention

    The joint position sense error (JPSE) will be calculated to determine cervicokinethesia

Secondary outcomes

  1. Changes in disability before and after the intervention

    Time frame: Baseline and one week after the intervention

    The Neck Disability Index (NDI) will be used to determine neck-related disability

  2. Changes in neck pain intensity before and after the intervention

    Time frame: Baseline and one week after the intervention

    An 11 points numerical pain rate scale (NPRS, 0-10) will be used to assess the intensity of neck pain

  3. Changes in widespread pressure pain sensitivity before and after the intervention

    Time frame: Baseline and 15 minutes after the intervention

    Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints and the tibialis anterior muscle

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2016
Registry last updated
Dec 9, 2016

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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