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Completed

NCT Number: NCT06077084

Neck Strengthening in Non-Specific Chronic Neck Pain

This study aims to investigate the effects of exercise interventions on neck muscle morphometry and composition in individuals with chronic non specific neck pain. The participants will be randomly assigned to either a moderate intensity or a high intensity neck strengthening program. The primary outcomes include neck disability. Secondary outcomes include changes in muscle volume and fat infiltration in the neck muscles measured using MRI, pain intensity, anxiety, and depression. The results of this study will contribute the future rehabilitation strategies.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de la Réunion

Le Tampon, La Réunion, 97430, Reunion

About this study

Chronic neck pain is a prevalent condition that significantly affects the quality of life for many individuals. It has been observed that individuals with chronic neck pain may experience alterations in muscle composition, including changes in muscle volume and the presence of fat infiltration. Exercise interventions have shown promise in improving muscle function and reducing pain in this population.

Objective:

The objective of this randomized controlled trial is to investigate the effects of two different exercise interventions on the disability and muscle composition in individuals with chronic non specific neck pain. The study aims to compare the outcomes of a moderate intensity neck strengthening program and a high intensity neck strengthening program.

Methods:

Participants will be recruited and randomly assigned to either the moderate intensity neck strengthening (MINS) group or the high intensity neck strengthening (HINS) group. The exercise interventions will be supervised by qualified physiotherapists and will consist of targeted exercises specifically designed to strengthen the neck muscles.

Outcomes :

Magnetic resonance imaging (MRI), Neck Disability Index (NDI), pain intensity, psychological measures such as anxiety and depression using validated questionnaires.

Data analysis :

Pre- and post-intervention measurements within each group and examining the between-group differences.

Conclusion:

This study aims to provide valuable insights into the effects of different exercise interventions on the disability an neck muscle morphometry/composition in individuals with chronic non specific neck pain. The study aims to enhance the understanding of the underlying mechanisms and potential benefits in this population. The findings may contribute to the development of targeted rehabilitation strategies that can effectively improve muscle function and reduce pain in individuals with chronic neck pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have experienced chronic non-specific neck pain for at least three months, exhibit symptoms triggered by neck movement, and score at least 20% on the Neck Disability Index questionnaire

Exclusion criteria

  • history of head or neck surgery or fracture, rheumatoid or metabolic disease, inability to understand or write in French, significant trauma such as a car accident, previous or current neoplasm, known psychiatric conditions like bipolar disorder, current pregnancy for women, clinical or radiological neurological features, cardiovascular or respiratory conditions, and drug or alcohol abuse

Treatment and study plan

Physiotherapy

Other

4months with multimodal physiotherapy. 2 sessions/week. Sessions consisted of two sessions of 1 hour per week, focusing on neck and arm movements. Each session included education and manual therapy (20 minutes), and exercises targeting neck extensors, flexors, and shoulder girdle muscles (40 minutes).

Low-intensity neck resistance training :

Participants have to perform arm, neck flexors and extensors exercise. motor control exercises focusing on deep neck muscles, slow dynamic and static contractions (10 to 20 seconds) with low resistance using TheraBand and weights ranging from 0.5 kg to 1 kg.

High-Intensity Neck resistance training :

neck flexors exercise, neck extensors exercise, and one exercise for shoulder/upper limb. static contractions (10-seconds) and dynamic neck movements using a handheld biofeedback dynamometer or weights from 50% to 80% of the 1-repetition maximum

Primary outcomes

  1. Neck disability Index score

    Time frame: At inclusion and 2 weeks after the 4-months treatment

    questionnaire, a higher score means worst disability

Secondary outcomes

  1. Neck muscle volume of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus,

    Time frame: At inclusion and 2 weeks after the 4-months treatment

    Muscle volume measured with magnetic resonance imagery, a higher volume could means better improvement

  2. Fat infiltration in neck muscle morphometry of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus.

    Time frame: At inclusion and 2 weeks after the 4-months treatment

    % of fat infiltration measured by magnetic resonance imagery, a higher score means worst fat infiltration

  3. Pain

    Time frame: At inclusion and 2 weeks after the 4-months treatment

    Numeric Pain Rating Scale of neck pain, a better score means worst pain

Sponsors and collaborators

Lead sponsor

Universite de La Reunion

Other

Collaborators

  • Le Mans Universite

Registry information

Official study title

High Versus Moderate Intensity Neck Strengthening Treatment for Improving Disability, Neck Muscle Morphometry and Composition in Non-Specific Chronic High Versus Moderate Intensity Neck Strengthening Treatment for Improving Disability, Neck Muscle Morphometry and Composition in Non-Specific Chronic Neck Pain

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

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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