Back to resultsEffects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain
Primary Purpose
Chronic Mechanical Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
suboccipital inhibition
INYBI
INYBI + upper cervical manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Mechanical Neck Pain
Eligibility Criteria
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).
Sites / Locations
- Ofistema
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
suboccipital inhibition technique group
INYBI group
combined treatment group
Arm Description
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.
Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation
Outcomes
Primary Outcome Measures
Changes in patients' cervical functionality between baseline and follow-up period.
cervical functionality is measured with the Neck Disability Index
Secondary Outcome Measures
Changes in patients' cervical mobility between baseline and follow-up periods.
The movements that will be measured with the CROM® are: flexion, extension, right and left rotation, right and left side-bending.
Changes in patients' pressure pain threshold between baseline and follow-up periods.
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).
Changes in patients' pain due to movement between baseline and follow-up periods.
The movements that will be measured with the visual analogue scale (VAS) are: flexion, extension, right and left rotation, right and left side-bending.
Full Information
NCT ID
NCT04777890
First Posted
February 20, 2021
Last Updated
June 14, 2021
Sponsor
Juan José Arjona Retamal
1. Study Identification
Unique Protocol Identification Number
NCT04777890
Brief Title
Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain
Official Title
Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan José Arjona Retamal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Mechanical Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
suboccipital inhibition technique group
Arm Type
Active Comparator
Arm Title
INYBI group
Arm Type
Experimental
Arm Description
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.
Arm Title
combined treatment group
Arm Type
Experimental
Arm Description
Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation
Intervention Type
Other
Intervention Name(s)
suboccipital inhibition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
INYBI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
INYBI + upper cervical manipulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in patients' cervical functionality between baseline and follow-up period.
Description
cervical functionality is measured with the Neck Disability Index
Time Frame
Baseline and two weeks after the second intervention.
Secondary Outcome Measure Information:
Title
Changes in patients' cervical mobility between baseline and follow-up periods.
Description
The movements that will be measured with the CROM® are: flexion, extension, right and left rotation, right and left side-bending.
Time Frame
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Title
Changes in patients' pressure pain threshold between baseline and follow-up periods.
Description
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).
Time Frame
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Title
Changes in patients' pain due to movement between baseline and follow-up periods.
Description
The movements that will be measured with the visual analogue scale (VAS) are: flexion, extension, right and left rotation, right and left side-bending.
Time Frame
Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Ofistema
City
Madrid
ZIP/Postal Code
28022
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain
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