Effectiveness of Two Exercise Programs on the Neck.

Effectiveness of Two Exercise Programs on the Neck. Secondary Analysis of a Randomized Clinical Trial.

The purpose of this study is to evaluate the clinical results in lower cervical range of motion, size deep muscles, endurance, craniovertebral angle and cervical propioception 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.

Study Overview

• Status: Completed
• Conditions: Subjects With Deep Cervical Muscle Strength Deficit
• Intervention / Treatment: Other: Training protocol with the cervical device for treatment (CDAT).; Other: Conventional training protocol

Detailed Description

Neck pain is one of the major public health problems, which has a great impact on people's lives, with high prevalence and recurrence rate. Cervical vertebral column is heavily dependent on the muscles for its physical support and activities. There are increasing evidences to support that cervical muscles may impair in patients with neck disorders. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with strength deficit of deep cervical muscles, 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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50018
    • Élite Fisioterapia, María Montessori 2.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Deep flexor strength deficit in craniocervical flexion test.
• Deep extensor strength deficit in neck extensor muscle endurance.
• ≤ 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training protocol with the cervical device for treatment (CDAT).; Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.	Other: Training protocol with the cervical device for treatment (CDAT).; Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Active Comparator: Conventional training protocol-; Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.	Other: Conventional training protocol; Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol.
No Intervention: Control Group; Subject continues with activities of daily living. Does not receive deep cervical muscle training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep neck flexor endurance Test.	The Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.	Baseline and 6 weeks, 10 weeks, 14 weeks
Neck extensor muscle endurance Test	Mean change from baseline in neck extensor muscle endurance Test after 6 weeks, 10 weeks and 14 weeks. The examiners assess the endurance of deep cervical extensor muscle.	Baseline and 6 weeks, 10 weeks, 14 weeks
Measurement of Cervical Multifidus and Longus Colli Muscle size.	The examiners assess these deep muscles with ultrasound after 6 weeks, 10 weeks and 14 weeks.	Baseline and 6 weeks, 10 weeks, 14 weeks
Physical activity enjoyment Scale (PACES)	The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active..." This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Neck Pain	Mean change from baseline in neck pain (VAS) after 6 weeks, 10 weeks and 14 weeks. The examiners assess the self-perceived intensity of neck pain using the Visual Analogue Scale (VAS). The VAS is designed to measure pain intensity. It consists of a 10 cm horizontal line where the patient marks the point that best represents their pain, ranging from 0 (no pain) to 10 (worst imaginable pain). The measure is designed to be completed directly by the patient. Scores are recorded in centimeters, with higher values indicating greater pain intensity.	Baseline and 6 weeks, 10 weeks, 14 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Principal Investigator: Pilar Pardos-Aguilella, UicCatalunya

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: muscle weakness; neck pain; exercise therapy; telerehabilitation; neck muscles
• Other Study ID Numbers: C.P.-C.I.PI21/357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No