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Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Right Cervical Manipulation
Left Cervical Manipulation
Sham Cervical Manipulation
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical spine, Spinal manipulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cesar Fernandez-de-Las-Peñas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Right Cervical Manipulation

Left Cervical Manipulation

Sham Cervical Manipulation

Arm Description

Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side.

Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side.

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.

Outcomes

Primary Outcome Measures

Changes in cervical kinesthetic sense before and after the intervention
The joint position sense error (JPSE) will be calculated to determine cervicokinethesia

Secondary Outcome Measures

Changes in disability before and after the intervention
The Neck Disability Index (NDI) will be used to determine neck-related disability
Changes in neck pain intensity before and after the intervention
An 11 points numerical pain rate scale (NPRS, 0-10) will be used to assess the intensity of neck pain
Changes in widespread pressure pain sensitivity before and after the intervention
Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints and the tibialis anterior muscle

Full Information

First Posted
December 30, 2015
Last Updated
December 8, 2016
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02645630
Brief Title
Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation
Official Title
Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Cervical spine, Spinal manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right Cervical Manipulation
Arm Type
Experimental
Arm Description
Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side.
Arm Title
Left Cervical Manipulation
Arm Type
Experimental
Arm Description
Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side.
Arm Title
Sham Cervical Manipulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Right Cervical Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Left Cervical Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Cervical Manipulation
Intervention Description
The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust
Primary Outcome Measure Information:
Title
Changes in cervical kinesthetic sense before and after the intervention
Description
The joint position sense error (JPSE) will be calculated to determine cervicokinethesia
Time Frame
Baseline and 15 minutes after the intervention
Secondary Outcome Measure Information:
Title
Changes in disability before and after the intervention
Description
The Neck Disability Index (NDI) will be used to determine neck-related disability
Time Frame
Baseline and one week after the intervention
Title
Changes in neck pain intensity before and after the intervention
Description
An 11 points numerical pain rate scale (NPRS, 0-10) will be used to assess the intensity of neck pain
Time Frame
Baseline and one week after the intervention
Title
Changes in widespread pressure pain sensitivity before and after the intervention
Description
Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints and the tibialis anterior muscle
Time Frame
Baseline and 15 minutes after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cesar Fernandez-de-Las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28921
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

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