Neck PainNCT06077084
Neck Strengthening in Non-Specific Chronic Neck Pain
A study testing Physiotherapy in people with Neck Pain, run by Universite de La Reunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteReunion
- Study dates
- 1 Feb 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity | Active comparator | Not described Receives: Other: Physiotherapy |
| High intensity | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability Index score
questionnaire, a higher score means worst disability
Measured: 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,
Muscle volume measured with magnetic resonance imagery, a higher volume could means better improvement
Measured: 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.
% of fat infiltration measured by magnetic resonance imagery, a higher score means worst fat infiltration
Measured: At inclusion and 2 weeks after the 4-months treatment
Pain
Numeric Pain Rating Scale of neck pain, a better score means worst pain
Measured: At inclusion and 2 weeks after the 4-months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Feb 2021
- Primary completion30 Nov 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite de La Reunion
- Sponsor type
- University, hospital or other
- Collaborators
- Le Mans Universite
- Responsible party
- Principal investigator, Francis Grondin, Universite de La Reunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077084
- Sponsor's protocol ID
- CERVIR
- Status last verified
- Oct 2023
- First submitted
- 6 Jun 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol \& Informed Consent Form will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06077084
- Acronym / sponsor ID
- CERVIR
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universite de La ReunionUniversity, hospital or other
- Collaborators
- Le Mans Universite
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity | Active comparator | Other: Physiotherapy |
| High intensity | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy4months 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 | Other | High intensity, Moderate intensity |
Primary outcome
Neck disability Index score
Time frame: At inclusion and 2 weeks after the 4-months treatment
questionnaire, a higher score means worst disability
3 secondary outcomes
Neck muscle volume of multifidus, spinalis cervicis longus colli, levator scapulae, spinalis capitis, splenius capitis, sternocleidomastoideus,
Time frame: 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.
Time frame: At inclusion and 2 weeks after the 4-months treatment
Pain
Time frame: At inclusion and 2 weeks after the 4-months treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No. Study Protocol \& Informed Consent Form will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Neck Pain, run by Universite de La Reunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck disability Index score (time frame: At inclusion and 2 weeks after the 4-months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.