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

Not Applicable

Completed

• Conditions: Chronic Mechanical Neck Pain
• Interventions: Other: suboccipital inhibition; Other: INYBI; Other: INYBI + upper cervical manipulation

• Registration Number: NCT04777890
• Lead Sponsor: Juan José Arjona Retamal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-28
• Study First Posted: 2021-03-02
• Study Start: 2021-03-20
• Status Verified: 2021-06
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
suboccipital inhibition technique group	suboccipital inhibition	-
INYBI group	INYBI	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.
combined treatment group	INYBI + upper cervical manipulation	Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation

Primary Outcome Measures

Name	Time	Method
Changes in patients' cervical functionality between baseline and follow-up period.	Baseline and two weeks after the second intervention.	cervical functionality is measured with the Neck Disability Index

Secondary Outcome Measures

Name	Time	Method
Changes in patients' pressure pain threshold between baseline and follow-up periods.	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).
Changes in patients' pain due to movement between baseline and follow-up periods.	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.
Changes in patients' cervical mobility between baseline and follow-up periods.	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.

Trial Locations

Locations (1)

Ofistema; 🇪🇸 Madrid, Spain