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

Muscle Weakness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288712
• Other study ID #: C.P. - C.I. PI21/357
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: August 2023
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

Other:
• Training protocol with the device cervical for treatment (CDAT)
Training protocol with the cervical device for treatment (CDAT)
• Conventional training protocol
Conventional training protocol

Locations

Country	Name	City	State
Spain	Élite Fisioterapia, María Montessori 2.	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 6 weeks, 10 weeks, 14 weeks
Primary	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.	Baseline and 6 weeks, 10 weeks, 14 weeks
Primary	Craniocervical flexion test	The examiners assess the strength of deep cervical flexors with craniocervical flexion test.	Baseline and 6 weeks, 10 weeks, 14 weeks
Primary	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.	Baseline and 6 weeks, 10 weeks, 14 weeks