Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation

NCT ID: NCT02645630

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cervical spine Spinal manipulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Right Cervical Manipulation

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

Group Type EXPERIMENTAL

Right Cervical Manipulation

Intervention Type 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

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

Group Type EXPERIMENTAL

Left Cervical Manipulation

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Sham Cervical Manipulation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Sham Cervical Manipulation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

César Fernández-de-las-Peñas

Head Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

URJC2015-161120155015

Identifier Type: -

Identifier Source: org_study_id