NCT02890394

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 11, 2016

Last Update Submit

August 31, 2016

Conditions

Keywords

Neck PainSuboccipital inhibitionPhysical Therapy

Outcome Measures

Primary Outcomes (2)

  • Change from pain threshold pressure after ten minutes from the suboccipital inhibition

    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

    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

Study Arms (4)

2 minutes Group

EXPERIMENTAL

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

4 minutes Group

EXPERIMENTAL

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

8 minutes Group

EXPERIMENTAL

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

not intervention Group

NO INTERVENTION

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.

Interventions

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

2 minutes Group4 minutes Group8 minutes Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 7, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share