Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain

August 31, 2016 updated by: Alejandro Sánchez Tejada, University of Alcala

Effectiveness of the Suboccipital Inhibition Technique in Patients With Mechanical Neck Pain: a Pilot Study

The project is based on checking the effectiveness of the technique of suboccipital inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In this technique the investigator would be carrying out the relaxation of the suboccipital muscles: lower rectus capitis posterior, superior oblique head straight back and head higher. It is a technique used very often but without knowledge about the time needed for implementation. In several studies that have used the technique it has been maintained for 2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three groups formed by patients with mechanical neck pain that they applied the technique two, four or ten minutes and a control group of patients with mechanical neck pain. The four groups were measured before and after treatment the pain threshold to pressure by algometer and conduct the test repositioning of the head to show any changes after application of the technique.

Study Overview

Status

Status

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

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.

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.
60

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

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women of full age .
  2. ≥ 15/50 rating in the Neck Disability Index
  3. Participants with good adhesion to the study .
  4. Participants who have signed informed after appropriate informed consent.

Exclusion Criteria:

  1. Cancer , inflammatory , infectious , vascular , neurological and metabolic processes.
  2. Patients who are under medical treatment.
  3. Patients with psychiatric illnesses.
  4. Women : pregnancy.
  5. Patients who have not signed the informed consent.

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: Factorial 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: 2 minutes Group
The group was perform the technique inhibition suboccipital two minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique.
Other: Suboccipital inhibition technique
Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull
Experimental: 4 minutes Group
The group was perform the technique inhibition suboccipital four minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique.
Other: Suboccipital inhibition technique
Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull
Experimental: 8 minutes Group
The group was perform the technique inhibition suboccipital eight minutes, collecting data by measuring with algometer and test repositioning of the head before and after the technique.
Other: Suboccipital inhibition technique
Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull
No Intervention: not intervention Group
The not intervention group will be asked to lie supine on the table for ten minutes, collecting data by measuring with algometer and test repositioning of the head before and after laying.

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
Change from pain threshold pressure after ten minutes from the suboccipital inhibition
Time Frame: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
Three measurements were performed with a rest period of 30 seconds between each measurement.
It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
Change from repositioning of the head after ten minutes from the suboccipital inhibition
Time Frame: It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured
a target is placed on the wall in front of the subject at a distance of 90 cm and adjusted to align with the reference position of the head. a helmet with a laser on top is used. For each test subjects will be instructed to memorize the initial reference position by carrying out a maximum cervical rotation and returning to the reference position without speed limit. Subjects undertake 10 trials. Before each test, the examiner manually reposition the subject's head to the reference position. Once the subject is instructed to conduct the test measurement.
It is measured at the beginning of the study. After ten minutes from the suboccipital inhibition is remeasured

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.
March 1, 2016

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.
August 1, 2016

Study Completion (Anticipated)

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.
September 1, 2016

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 11, 2016

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 31, 2016

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.
September 7, 2016

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.
September 7, 2016

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.
August 31, 2016

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.
August 1, 2016

More Information

Terms related to this study

Keywords

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.
  • UAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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