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Trial record 13 of 12465 for:    cervical

Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

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ClinicalTrials.gov Identifier: NCT02645630
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Right Cervical Manipulation Other: Left Cervical Manipulation Other: Sham Cervical Manipulation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain
Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Right Cervical Manipulation
Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side.
Other: Right Cervical Manipulation
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.

Experimental: Left Cervical Manipulation
Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side.
Other: Left Cervical Manipulation
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.

Active Comparator: Sham Cervical Manipulation
Patients assigned to this group will receive a sham cervical spine manipulation targeting the C3/C4 segment on both sides. No therapeuthic thrust will be applied.
Other: Sham Cervical Manipulation
The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645630


Locations
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Spain
Cesar Fernandez-de-Las-Peñas
Alcorcon, Madrid, Spain, 28921
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD Universidad Rey Juan Carlos

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Responsible Party: César Fernández-de-las-Peñas, Head Division, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02645630     History of Changes
Other Study ID Numbers: URJC2015-161120155015
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by César Fernández-de-las-Peñas, Universidad Rey Juan Carlos:
Cervical spine
Spinal manipulation

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms