Immediate Effects of the C0-C1 Mobilization Technique in Patients With Chronic Neck Pain

Cervical Pain Clinical Trial

Official title:

Immediate Effects of the C0-C1 Mobilization Technique on Upper Cervical Mobility and Pressure Threshold in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351971
• Other study ID #: 1909-91
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2020
• Source: Universidad San Sebastián
• Contact: GONZALO ARIAS, M.ed.
• Phone: 56977623954
• Email: gonzalo.arias[@]uss.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Skeletal muscle-type pain is one of the main reasons for consultations in health centers. In Chile, it is estimated that the prevalence reaches 33% in men and 50% in women, increasing considerably with age, with cervical pain being one of the main conditions, estimating that 80% of the population has experienced cervicalgia at some time. lifetime. The main symptom is neck pain and restriction of movement, mainly affecting the mobility of the upper cervical region. Although there are studies evaluating the effectiveness of manual techniques, there are currently no studies evaluating the effects on cervical muscle activity and pressure threshold. Therefore, the objective of the present investigation is to evaluate the immediate effects of a manual therapy technique on the threshold pressure of muscular trigger points and on the muscular activity of the upper cervical region in patients with chronic pain and restriction of cervical mobility. higher.

Methods: Clinical trial, randomized, prospective, double-blind study (patient and evaluator). The participants (21 subjects) were divided into 2 groups. The control group will receive a C0-C0 placebo mobilization technique and the experimental group will receive the C0-C1 mobilization technique. In both groups the technique will be carried out by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 min. Pressure threshold, activation of the superficial deep musculature and articular range of the upper cervical region will be measured.

Description:

Most cases of pain in the neck region are of mechanical origin. In Spain, its annual prevalence has been estimated to range between 16.7% and 75.1% 2. In Chile, the prevalence is estimated to be 30% in Men and 50% in women, increasing as age increases. It is estimated that, of these cases, 44% have a duration of 6 months or more, giving rise to difficulties not only at work but also in daily life, at home, economically, even in emotional aspects.

The most common symptom is pain in the neck region, which may be associated with restricted movement, dizziness, and manifestations of stress. A large proportion of movement of the cervical spine takes place in the C1-C2 segment, where up to 50% of the total rotation of the cervical spine occurs. There are several techniques to restore cervical mobility, but few of them comply with the guidelines of the IFOMPT (International Federation of Manual Orthopedic Therapists) on the safety and efficacy in the treatment of hypomobility of the upper cervical spine, avoiding positions at the end of the cervical range of motion, especially rotation and extension, and there is also limited scientific evidence of its effectiveness.

The C0-C1 dorsal mobilization technique complies with these recommendations and have been used in previous studies, although there is no evidence of its effects on range of motion, activation of deep cervical musculature and pressure threshold in patients with chronic mechanical cervicalgia. Therefore, the objective of the present investigation is to determine the effects of the dorsal mobilization technique of the atlanto-occipital joint (C0-C1) as adjuvant treatments for Kinesitherapy in users with chronic cervical pain of mechanical origin and rotation deficit in the upper cervical spine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and over

• Chronic cervical pain

• Sign the informed consent form

Exclusion Criteria:

• History of cervical trauma (Sprains, fracture and / or dislocation of cervical joints)

• Subjects with administration of pain relievers, opiates or muscle relaxants

• Inability to tolerate the supine position

• Subjects with vertiginous syndrome

• Subjects with cognitive impairment

Related Conditions & MeSH terms

• Cervical Pain
• Musculoskeletal Manipulations
• Neck Pain

Intervention

Other:
• Intervention Group
The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.
• Placebo group
The technique consists of placing the patient in the supine position, one hand is located in the arches of the atlas, the other hand is located in the occipital. The therapist's shoulder is located in the anterior region. This position is maintained for 5 minutes without exerting pressure.

Locations

Country	Name	City	State
Chile	Universidad San Sebastián	Concepción

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Sebastián

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in grade of range of motion of the cervical spine in patients with chronic neck pain	The procedure consists of evaluating the cervical flexion, extension, inclination and rotation ranges. The final record will correspond to the average of two measurements on one side and on the contralateral side. The range of motion will be measured with a goniometer	pre-intervention/immediately after the intervention
Secondary	Changes in muscle pressure threshold, measured in kilograms, in patients with chronic neck pain	Minimum subject pressure perceived as painful when applied gradually and increasing. This variable is evaluated using an algometer measured in kilograms of pressure.	pre-intervention/immediately after the intervention