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Completed

NCT Number: NCT05331482

Effectiveness of Two Exercise Programs on the Neck.

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.

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Key information

Conditions

Subjects With Deep Cervical Muscle Strength Deficit Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Élite Fisioterapia, María Montessori 2.

Zaragoza, 50018, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 protocol

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. Neck Disability Index

    Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks

    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).

  2. Neck Pain

    Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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