Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain

June 14, 2021 updated by: Juan José Arjona Retamal

Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial

The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine which of these techniques is the most effective in the variables studied. In order to do so, 96 subjects participated in the study, being assigned to the 3 intervention groups. We expected the combined treatment (INYBI instrument + upper cervical manipulation) to be the one to produce the best results.

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.

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.
100

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, Spain, 28022
        • Ofistema

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 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants aged between 18 and 40 all diagnosed with chronic mechanic cervical pain with an evolution of at least 3 months and who show pain that increases with maintained postures, during movement and during spinal muscles palpation.

Exclusion Criteria:

  • participants that can't read and/or fill in the informed consent, either due to a language and/or cognition alteration or age-related factors.
  • subjects with psychological pathologies, such as hysteria, depression or anxiety.
  • subjects that have received a manual treatment two months before the beginning of the clinical trial.
  • subjects who have been recommended by a physician or an anesthetist to receive any type of analgesic, anti-inflammatory or neuromodulator medication, such as antidepressants, antiepileptics and benzodiazepines. If the patient took in this type of medication in an occasional way 72 hours before the beginning of the study, he/she could participate.
  • the treatment and assessment techniques will be avoided if: fear to vertebral manipulation in the upper cervical area or positive Klein test and other integrity test of the vertebral artery, positive cervical instability test and positive Spurling test (foraminal compression test).

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
  • Masking: DOUBLE

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.
ACTIVE_COMPARATOR: suboccipital inhibition technique group
Other: suboccipital inhibition
The therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period.
EXPERIMENTAL: INYBI group
Participants in this group will be treated with the INYBI, an instrument designed for treating the suboccipital area, in a more precise way than the manual technique.
Other: INYBI
The therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency.
EXPERIMENTAL: combined treatment group
Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation
Other: INYBI + upper cervical manipulation
The participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out

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
Changes in patients' cervical functionality between baseline and follow-up period.
Time Frame: Baseline and two weeks after the second intervention.
cervical functionality is measured with the Neck Disability Index
Baseline and two weeks after the second intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in patients' cervical mobility between baseline and follow-up periods.
Time Frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
The movements that will be measured with the CROM® are: flexion, extension, right and left rotation, right and left side-bending.
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pressure pain threshold between baseline and follow-up periods.
Time Frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
The pressure pain threshold will be measured with an algometer (Mechanical Algometer Pain Test® de Wagner Instrument, USA) in the suboccipital and trapezius muscles (both left and right).
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pain due to movement between baseline and follow-up periods.
Time Frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
The movements that will be measured with the visual analogue scale (VAS) are: flexion, extension, right and left rotation, right and left side-bending.
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.

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.
Juan José Arjona Retamal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

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 20, 2021

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.
June 7, 2021

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.
June 7, 2021

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).
February 20, 2021

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.
February 28, 2021

First Posted (ACTUAL)

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.
March 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

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.
June 15, 2021

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.
June 14, 2021

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.
June 1, 2021

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.
  • University Rey Juan Carlos

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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