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

Chronic Mechanical Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777890
• Other study ID #: University Rey Juan Carlos
• Status: Completed
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: June 7, 2021

Study information

• Verified date: June 2021
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Mechanical Neck Pain
• Neck Pain

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Spain	Ofistema	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Juan José Arjona Retamal

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patients' cervical functionality between baseline and follow-up period.	cervical functionality is measured with the Neck Disability Index	Baseline and two weeks after the second intervention.
Secondary	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.	Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Secondary	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).	Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Secondary	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.	Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.