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

Primary Purpose

Musculoskeletal Manipulations, Cervical Pain

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Intervention Group
Placebo group
Sponsored by
Universidad San Sebastián
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Manipulations focused on measuring manual therapies, Chronic Pain, Range of Motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad San SebastiánRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Placebo group

Arm Description

The dorsal sliding technique C0-C1 will be applied to this group.

A placebo dorsal mobilization technique will be applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 10, 2020
Last Updated
April 15, 2020
Sponsor
Universidad San Sebastián
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1. Study Identification

Unique Protocol Identification Number
NCT04351971
Brief Title
Immediate Effects of the C0-C1 Mobilization Technique in Patients With Chronic Neck Pain
Official Title
Immediate Effects of the C0-C1 Mobilization Technique on Upper Cervical Mobility and Pressure Threshold in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Sebastián

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Manipulations, Cervical Pain
Keywords
manual therapies, Chronic Pain, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Study participants will be assigned a random number and will be divided into two research groups (control group and intervention group). In this sense, both the patient and the therapist in charge of carrying out the evaluation will not know which group each subject belongs to.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The dorsal sliding technique C0-C1 will be applied to this group.
Arm Title
Placebo group
Arm Type
Sham Comparator
Arm Description
A placebo dorsal mobilization technique will be applied
Intervention Type
Other
Intervention Name(s)
Intervention Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in grade of range of motion of the cervical spine in patients with chronic neck pain
Description
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
Time Frame
pre-intervention/immediately after the intervention
Secondary Outcome Measure Information:
Title
Changes in muscle pressure threshold, measured in kilograms, in patients with chronic neck pain
Description
Minimum subject pressure perceived as painful when applied gradually and increasing. This variable is evaluated using an algometer measured in kilograms of pressure.
Time Frame
pre-intervention/immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GONZALO ARIAS, M.ed.
Phone
56977623954
Email
gonzalo.arias@uss.cl
Facility Information:
Facility Name
Universidad San Sebastián
City
Concepción
ZIP/Postal Code
4081322
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GONZALO ARIAS, M.ed.
Phone
56977623954
Email
gonzalo.arias@uss.cl

12. IPD Sharing Statement

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

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