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Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.

Primary Purpose

Muscle Weakness, Cervical Disability

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Training protocol with the device cervical for treatment (CDAT)
Conventional training protocol
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring neck pain, exercise therapy, muscle weakness, telerehabilitation, neck muscles

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Deep flexor strength deficit in craniocervical flexion test.
  • Deep extensor strength deficit in neck extensor muscle endurance test.
  • ≤ 14 score in Neck disability Index.

Exclusion Criteria:

  • Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
  • Have received cervical manual therapy treatment during the last six month.
  • A history of cervical trauma or surgery during the last year.
  • Chronic neck pain occurring during the last six months (intensity, visual analogue scale >3/10, frequency > 2 days/week, duration >3 hours/day).

Sites / Locations

  • Élite Fisioterapia, María Montessori 2.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental: Training protocol with the cervical device for treatment (CDAT).

Conventional training protocol:

Control Group

Arm Description

Endurance and stabilization training program of deep cervical flexors with the cervical device for treatment. Endurance and stabilization training program of deep cervical extensors with the cervical device for treatment.

Endurance and stabilization training program of deep cervical flexors with conventional protocol. Endurance and stabilization training program of deep cervical extensors with conventional protocol.

Subject continues with activities of daily living. Does not receive deep cervical muscle training.

Outcomes

Primary Outcome Measures

Neck Disability Index
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the self-perceived disability from neck pain using the NDI. The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete. Item scores range from 0 (no disability) to 5 (total disability), with the minimum score is 0 (no disability) and maximum score of 50 (complete disability).
Cervical Spine range of motion
Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension and flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.
Craniocervical flexion test
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
GLOBAL RATING OF CHANGE SCALE (GROC)
The examiners assess self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores after 6 weeks, 10 weeks and 14 weeks. The GROC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Item scores range from - 7 (A very great deal worse) to + 7 A very great deal better.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2022
Last Updated
August 10, 2023
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05288712
Brief Title
Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.
Official Title
Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit in Cervical Range of Motion, Muscle Endurance and Neck Disability.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

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
The purpose of this study is to evaluate the clinical results produced by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit and mild neck disability.
Detailed Description
Cervical pain is in many cases a decrease in the quality of life.The cervical spine is the most mobile region of the spine which also must be strong enough in order to support the weight of the skull. Deficits in deep cervical muscle strength are related to different clinical conditions: cervicogenic dizziness, cervical radiculopathy, cervical mechanical-chronic, cervical pain and cervical instability. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with mild disability and strength deficit of the deep cervical muscle, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Cervical Disability
Keywords
neck pain, exercise therapy, muscle weakness, telerehabilitation, neck muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial with 3 different groups
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Training protocol with the cervical device for treatment (CDAT).
Arm Type
Experimental
Arm Description
Endurance and stabilization training program of deep cervical flexors with the cervical device for treatment. Endurance and stabilization training program of deep cervical extensors with the cervical device for treatment.
Arm Title
Conventional training protocol:
Arm Type
Active Comparator
Arm Description
Endurance and stabilization training program of deep cervical flexors with conventional protocol. Endurance and stabilization training program of deep cervical extensors with conventional protocol.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subject continues with activities of daily living. Does not receive deep cervical muscle training.
Intervention Type
Other
Intervention Name(s)
Training protocol with the device cervical for treatment (CDAT)
Intervention Description
Training protocol with the cervical device for treatment (CDAT)
Intervention Type
Other
Intervention Name(s)
Conventional training protocol
Intervention Description
Conventional training protocol
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the self-perceived disability from neck pain using the NDI. The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete. Item scores range from 0 (no disability) to 5 (total disability), with the minimum score is 0 (no disability) and maximum score of 50 (complete disability).
Time Frame
Baseline and 6 weeks, 10 weeks, 14 weeks
Title
Cervical Spine range of motion
Description
Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension and flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.
Time Frame
Baseline and 6 weeks, 10 weeks, 14 weeks
Title
Craniocervical flexion test
Description
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
Time Frame
Baseline and 6 weeks, 10 weeks, 14 weeks
Title
GLOBAL RATING OF CHANGE SCALE (GROC)
Description
The examiners assess self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores after 6 weeks, 10 weeks and 14 weeks. The GROC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Item scores range from - 7 (A very great deal worse) to + 7 A very great deal better.
Time Frame
Baseline and 6 weeks, 10 weeks, 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Deep flexor strength deficit in craniocervical flexion test. Deep extensor strength deficit in neck extensor muscle endurance test. ≤ 14 score in Neck disability Index. Exclusion Criteria: Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination). Have received cervical manual therapy treatment during the last six month. A history of cervical trauma or surgery during the last year. Chronic neck pain occurring during the last six months (intensity, visual analogue scale >3/10, frequency > 2 days/week, duration >3 hours/day).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Pardos-Aguilella, teacher
Organizational Affiliation
UicCatalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Élite Fisioterapia, María Montessori 2.
City
Zaragoza
ZIP/Postal Code
50018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.

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