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

NCT04777890 | Completed

• 1 other identifier: University Rey Juan Carlos
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Mechanical Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (3)

suboccipital inhibition technique group

ACTIVE COMPARATOR

Other: suboccipital inhibition

INYBI group

EXPERIMENTAL

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.

Other: INYBI

combined treatment group

EXPERIMENTAL

Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation

Other: INYBI + upper cervical manipulation

Interventions

suboccipital inhibition OTHER

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.

suboccipital inhibition technique group

INYBI OTHER

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 group

INYBI + upper cervical manipulation OTHER

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

combined treatment group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Juan José Arjona Retamal: lead

Study Sites (1)

Ofistema

Madrid, 28022, Spain

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 2, 2021
• Study Start: March 20, 2021
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)