Subjects With Deep Cervical Muscle Strength DeficitNCT05331482
Effectiveness of Two Exercise Programs on the Neck.
A study testing Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol in people with Subjects With Deep Cervical Muscle Strength Deficit, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Deep Cervical Muscle Strength Deficit
- What is being tested?
- Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance.
- ≤ 14 score in Neck disability Index
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Training protocol with the cervical device for treatment (CDAT)., Conventional training protocol
- Keywords
- neck muscles, neck pain, exercise therapy, telerehabilitation, muscle weakness
- Medical subject headings
- Neck Pain, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training protocol with the cervical device for treatment (CDAT).Other
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Conventional training protocolOther
Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol.
| Study group | Role | What they receive |
|---|---|---|
| Training protocol with the cervical device for treatment (CDAT). | Experimental | Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment. Receives: Other: Training protocol with the cervical device for treatment (CDAT). |
| Conventional training protocol- | Active comparator | Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. Receives: Other: Conventional training protocol |
| Control Group | No intervention | Subject continues with activities of daily living. Does not receive deep cervical muscle training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start11 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Deep Cervical Muscle Strength DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial with 3 different groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Pardos Aguilella, Universitat Internacional de Catalunya
- Investigators
- Pilar Pardos-Aguilella, Principal investigator, UicCatalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331482
- Sponsor's protocol ID
- C.P.-C.I.PI21/357
- Status last verified
- Aug 2023
- First submitted
- 10 Apr 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Exercise Programs on the Neck. Secondary Analysis of a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05331482
- Acronym / sponsor ID
- C.P.-C.I.PI21/357
- Keywords
- neck muscles, neck pain, exercise therapy, telerehabilitation, muscle weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a randomized controlled trial with 3 different groups
| Arm | Type | Receives |
|---|---|---|
| Training protocol with the cervical device for treatment (CDAT). | Experimental | 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. |
| Conventional training protocol- | Active comparator | Other: Conventional training protocolEndurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol. |
| Control Group | No intervention | –Subject continues with activities of daily living. Does not receive deep cervical muscle training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance.
- ≤ 14 score in Neck disability Index
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). |
| Conventional training protocolEndurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol. | Other | Conventional training protocol- |
Primary outcome
Deep neck flexor endurance Test.
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
The Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.
Neck extensor muscle endurance Test
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
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.
Measurement of Cervical Multifidus and Longus Colli Muscle size.
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
The examiners assess these deep muscles with ultrasound after 6 weeks, 10 weeks and 14 weeks.
Physical activity enjoyment Scale (PACES)
Time frame: 6 weeks
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).
2 secondary outcomes
Neck Disability Index
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
Neck Pain
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Pardos-Aguilella principal investigator
UicCatalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training protocol with the cervical device for treatment (CDAT). and Conventional training protocol in people with Subjects With Deep Cervical Muscle Strength Deficit, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep neck flexor endurance Test. (time frame: Baseline and 6 weeks, 10 weeks, 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.