Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain

March 23, 2024 updated by: Raúl Romero del Rey, Clínica Ciudad de Almería

A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial

There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04008
        • Clínica Ciudad de Almería

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptom persistence for more than 12 weeks.
  • Age from 18 to 55 years.
  • Localized pain in the cervical spine.
  • Symptoms are caused by cervical movement or sustained postures.

Exclusion Criteria:

  • Stage acute of symptoms.
  • Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).
  • Patients with previous neck trauma or cervical spine surgery.
  • Patients diagnosed with cervical radiculopathy.
  • Patients diagnosed with fibromyalgia.
  • Have been treated with manual therapy in the last 3 months.
  • Receiving other treatment during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper cervical spine manipulation group
Spinal thrust joint manipulation on the atlantoaxial joint
Other: Spinal manipulation
Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.
Active Comparator: Cervicothoracic spine manipulations group
Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1).
Other: Spinal manipulation
Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neck pain at rest: Numeric Pain Rating Scale (0-10)
Time Frame: Baseline and 7 days post-treatment
Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).
Baseline and 7 days post-treatment
Change in neck disability: Neck Disability Index (0-50)
Time Frame: Baseline and 7 days post-treatment
Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.
Baseline and 7 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in flexion movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment
Change in extension movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment
Change in rigth lateral flexion movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in right lateral flexion. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment
Change in left lateral flexion movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in left lateral flexion. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment
Change in right rotation movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in right rotation. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment
Change in left rotation movement: Cervical Range of Motion device
Time Frame: Baseline and 7 days post-treatment
Range of cervical motion in left rotation. Measured with a Cervical Range of Motion (CROM) device
Baseline and 7 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica Ciudad de Almería

Investigators

  • Principal Investigator: Raúl Romero del Rey, Mr, Clínica Ciudad de Almería

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • spinal manipulation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe