Clinical trial NCT05288712: 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
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Cervical Disability
Keywords: neck pain
exercise therapy
muscle weakness
telerehabilitation
neck muscles
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial with 3 different groups
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Neck Disability Index
timeFrame: Baseline and 6 weeks, 10 weeks, 14 weeks
measure: Cervical Spine range of motion
timeFrame: Baseline and 6 weeks, 10 weeks, 14 weeks
measure: Craniocervical flexion test
timeFrame: Baseline and 6 weeks, 10 weeks, 14 weeks
measure: GLOBAL RATING OF CHANGE SCALE (GROC)
timeFrame: Baseline and 6 weeks, 10 weeks, 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Élite Fisioterapia, María Montessori 2.
Study officials:
affiliation: UicCatalunya
name: Pilar Pardos-Aguilella, teacher
role: PRINCIPAL_INVESTIGATOR
References: