Neck Pain Clinical Trial
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
| 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 |
| Verified date | October 2023 |
| Source | Universite de La Reunion |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Réunion | Université de la Réunion | Le Tampon | La Réunion |
| Lead Sponsor | Collaborator |
|---|---|
| Universite de La Reunion | Le Mans Universite |
Réunion,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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