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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06077084
Other study ID # CERVIR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date March 1, 2022

Study information

Verified date October 2023
Source Universite de La Reunion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 1, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy
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

Locations

Country Name City State
Réunion Université de la Réunion Le Tampon La Réunion

Sponsors (2)

Lead Sponsor Collaborator
Universite de La Reunion Le Mans Universite

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck disability Index score questionnaire, a higher score means worst disability At inclusion and 2 weeks after the 4-months treatment
Secondary Neck muscle volume of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus, Muscle volume measured with magnetic resonance imagery, a higher volume could means better improvement At inclusion and 2 weeks after the 4-months treatment
Secondary Fat infiltration in neck muscle morphometry of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus. % of fat infiltration measured by magnetic resonance imagery, a higher score means worst fat infiltration At inclusion and 2 weeks after the 4-months treatment
Secondary Pain Numeric Pain Rating Scale of neck pain, a better score means worst pain At inclusion and 2 weeks after the 4-months treatment
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