Neck Strengthening in Non-Specific Chronic Neck Pain

NCT06077084 | Completed

• 1 other identifier: CERVIR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Neck disability Index score

  questionnaire, a higher score means worst disability

  At inclusion and 2 weeks after the 4-months treatment

Secondary Outcomes (3)

• 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

• 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

• Pain

  At inclusion and 2 weeks after the 4-months treatment

Study Arms (2)

Moderate intensity

ACTIVE COMPARATOR

Other: Physiotherapy

High intensity

ACTIVE COMPARATOR

Other: Physiotherapy

Interventions

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

High intensity; Moderate intensity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universite de La Reunion: lead
• Le Mans Universite: collaborator

Study Sites (1)

Université de la Réunion

Le Tampon, La Réunion, 97430, Reunion

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, physiotherapist

Model Details: RCT

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: October 11, 2023
• Study Start: February 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: March 1, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)