Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645630
• Other study ID #: URJC2015-161120155015
• Status: Completed
• Phase: N/A
• First received: December 30, 2015
• Last updated: December 8, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.
• 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.
• Sham Cervical Manipulation
The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust

Locations

Country	Name	City	State
Spain	Cesar Fernandez-de-Las-Peñas	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cervical kinesthetic sense before and after the intervention	The joint position sense error (JPSE) will be calculated to determine cervicokinethesia	Baseline and 15 minutes after the intervention	Yes
Secondary	Changes in disability before and after the intervention	The Neck Disability Index (NDI) will be used to determine neck-related disability	Baseline and one week after the intervention	Yes
Secondary	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	Baseline and one week after the intervention	Yes
Secondary	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	Baseline and 15 minutes after the intervention	Yes