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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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
      • 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

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
Intervention / Treatment
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

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

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

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)

March 20, 2021

Primary Completion (ACTUAL)

June 7, 2021

Study Completion (ACTUAL)

June 7, 2021

Study Registration Dates

First Submitted

February 20, 2021

First Submitted That Met QC Criteria

February 28, 2021

First Posted (ACTUAL)

March 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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