Neck Strengthening in Non-Specific Chronic Neck Pain

Sponsor
Universite de La Reunion (Other)
Overall Status
Completed
CT.gov ID
NCT06077084
Collaborator
Le Mans Universite (Other)
50
1
2
12.9
3.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiotherapy
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Moderate intensity

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

Active Comparator: High intensity

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

Outcome Measures

Primary Outcome Measures

  1. Neck disability Index score [At inclusion and 2 weeks after the 4-months treatment]

    questionnaire, a higher score means worst disability

Secondary Outcome Measures

  1. Neck muscle volume of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus, [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. [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 [At inclusion and 2 weeks after the 4-months treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université de la Réunion Le Tampon La Réunion Réunion 97430

Sponsors and Collaborators

  • Universite de La Reunion
  • Le Mans Universite

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francis Grondin, PhD-student, physiotherapist, Universite de La Reunion
ClinicalTrials.gov Identifier:
NCT06077084
Other Study ID Numbers:
  • CERVIR
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2023