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Neck Strengthening in Non-Specific Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Universite de La Reunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université de la Réunion

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moderate intensity

High intensity

Arm Description

Outcomes

Primary Outcome Measures

Neck disability Index score
questionnaire, a higher score means worst disability

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2023
Last Updated
October 4, 2023
Sponsor
Universite de La Reunion
Collaborators
Le Mans Universite
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1. Study Identification

Unique Protocol Identification Number
NCT06077084
Brief Title
Neck Strengthening in Non-Specific Chronic Neck Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universite de La Reunion
Collaborators
Le Mans Universite

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate intensity
Arm Type
Active Comparator
Arm Title
High intensity
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Neck disability Index score
Description
questionnaire, a higher score means worst disability
Time Frame
At inclusion and 2 weeks after the 4-months treatment
Secondary Outcome Measure Information:
Title
Neck muscle volume of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus,
Description
Muscle volume measured with magnetic resonance imagery, a higher volume could means better improvement
Time Frame
At inclusion and 2 weeks after the 4-months treatment
Title
Fat infiltration in neck muscle morphometry of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus.
Description
% of fat infiltration measured by magnetic resonance imagery, a higher score means worst fat infiltration
Time Frame
At inclusion and 2 weeks after the 4-months treatment
Title
Pain
Description
Numeric Pain Rating Scale of neck pain, a better score means worst pain
Time Frame
At inclusion and 2 weeks after the 4-months treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Université de la Réunion
City
Le Tampon
State/Province
La Réunion
ZIP/Postal Code
97430
Country
Réunion

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study Protocol & Informed Consent Form will be shared

Learn more about this trial

Neck Strengthening in Non-Specific Chronic Neck Pain

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