The Effectiveness of Exercises Protocol in Management of Neck Pain

November 30, 2015 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

The Effectiveness of Two Training Protocols When Managing Chronic Cervical Pain: Controlled Randomized Clinical Trial.

This study will verify whether the cranio-cervical flexion coordination (motor control) and muscle strength training protocol is more effective in improving muscle than the proprioception and muscle strength protocol in patients with chronic neck pain.

Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol will improve muscle function more than the proprioception and muscle strength protocol in patients with chronic cervical pain.

Objective: To find out if applying the strength therapeutic exercise protocol and the craniocervical flexion coordination (motor control) training is more effective than the strength and articular repositioning protocol when carrying out the craniocervical flexion test in patients with chronic cervical pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neck pain is delimited by two horizontal lines, one through the lower portion of the occipital region and one through the spinous process of the first thoracic vertebra. This pain is reproduced by neck movements or exploratory provocation tests. Scientific studies show that at least two out of three people will experience neck pain throughout life. Some of the causes are traumatism and whiplash although sometimes pain is idiopathic.

This study will verify whether the cranio-cervical flexion coordination (motor control) and muscle strength training protocol is more effective in improving muscle than the proprioception and muscle strength protocol in patients with chronic neck pain.

The project design will be a randomized controlled evaluator-blinded clinical trial with two intervention groups:

Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.

Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception. Measurements will be done at the beginning of the study, pre and post-treatment, one month and two months after treatment and throughout the six month treatment. Each session will last 45 minutes and therapy will be performed without provoking the patient symptoms.

Intervention

Experimental group 1: will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al1, 2 and exercises to increase strength-endurance on the neck flexor muscles.

Control group 2: will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28871
        • Alcala University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of cervical pain of at least 3 months.
  • Between 18 and 55 years old.
  • Altered movement and/or loss of cervical control.
  • Pain after palpation of the muscles to be treated.

Exclusion Criteria:

  • Previous history of central neurological condition.
  • Previous surgery of the cervical, cranial, scapular waist, upper limb or jaw.
  • Having received specific treatment or therapy of the cervical region in the 6 months prior to the study.
  • Neck pain or headache with no musculo-skeletal causes.
  • Any other disorder that prevents physical activity.
  • Having received psychological treatment due to neck pain.
  • Patients with fibromyalgia, rheumatoid arthritis, vascular diseases, neoplasm or vestibular system pathologies.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: strength-endurance exercises
Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.
Other: motor control exercises
Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles
Placebo Comparator: strength-endurance and proprioception
Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.
Other: muscle strength-endurance and proprioception
Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Craniocervical Flexion Test
Time Frame: up to six months after treatment

This test measures the activation and resistance of the neck flexor muscles in 5 steps, with isometric contractions on the patient every 2 mmHg, increasing pressure sequentially from 20 mmHg up to 30 mmHg.

Once carried out the test, performance will be measured by the pressure level achieved and the number of times pressure can be maintained by the patient with the correct cranioflexion movement in each level.
up to six months after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alcala

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2013/046/20140528

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.

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