- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890394
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
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women of full age .
- ≥ 15/50 rating in the Neck Disability Index
- Participants with good adhesion to the study .
- Participants who have signed informed after appropriate informed consent.
Exclusion Criteria:
- Cancer , inflammatory , infectious , vascular , neurological and metabolic processes.
- Patients who are under medical treatment.
- Patients with psychiatric illnesses.
- Women : pregnancy.
- 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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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
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
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
March 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
August 11, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Estimate)
September 7, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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