NCT02645630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 30, 2015

Last Update Submit

December 8, 2016

Conditions

Neck Pain

Keywords

Cervical spineSpinal manipulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Changes in disability before and after the intervention

    Baseline and one week after the intervention

  • Changes in neck pain intensity before and after the intervention

    Baseline and one week after the intervention

  • Changes in widespread pressure pain sensitivity before and after the intervention

    Baseline and 15 minutes after the intervention

Study Arms (3)

Right Cervical Manipulation

EXPERIMENTAL

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

Other: Right Cervical Manipulation

Left Cervical Manipulation

EXPERIMENTAL

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

Other: Left Cervical Manipulation

Sham Cervical Manipulation

ACTIVE COMPARATOR

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

Interventions

Right Cervical ManipulationOTHER

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.

Right Cervical Manipulation
Left Cervical ManipulationOTHER

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.

Left Cervical Manipulation
Sham Cervical ManipulationOTHER

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

Sham Cervical Manipulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Division

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 5, 2016

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)