Neck PainNCT02656030
Effects of Specific Training for Deep Neck Muscle
A study testing semispinalis cervicis resisted exercise and cranio-cervical flexion exercise in people with Neck Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- semispinalis cervicis resisted exercise and cranio-cervical flexion exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2015to Dec 2017
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic mechanical neck pain
- Aged between 18 to 59 years
- The symptom more than three months in duration
- A baseline the Thai version of Neck Disability Index (NDI-TH) score of 10 percent or greater
Who cannot join
- a previous history of whiplash injury
- a previous history injury to the cervical and thoracic spine
- diagnosed with osteoporosis, malignancy or other spinal inflection
- a positive vertebro-basilar artery insufficient test
- diagnosed with cervical radiculopathy and/or myelopathy
Trial locations and contacts
1 site in 1 country.
Thavatchai Suvarnnato, M.Sc. PT contact
Thailand1 site, 1 recruiting
- Recruiting
Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
Muang, Changwat Khon Kaen, 40002
Thavatchai Suvarnnato, M.Sc. PT, +66890092175, suvarnnato@hotmail.com
About this study
Official title: Effects of Specific Training of Deep Cervical Muscles in Chronic Mechanical Neck Pain
Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain.
Exercise is known to be an important component of treatment programs for patients with neck pain. Recently, many studies have focused on specific training on deep cervical muscles, especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck disability, changing in activation of deep cervical flexor muscles. Further, the cervical extensor muscles are believed to be equally important for the rehabilitation of patients with neck pain. However, the retention effect of semispinalis cervicis exercise is unknown. Therefore, the semispinalis cervicis exercise still need more evidence to support clinically effects.
The current study will be conducted to fill the gap of the previous study in immediately, short, and long term effects of semispinalis cervicis exercise in chronic neck pain.
Read the detailed description
Neck pain is a second the most common problems in musculoskeletal problems the low back pain in general population.The prevalence of neck pain at the some point in their lifetime in general population had been reported to be between 43 to 66.7 percent.the neck problems could be involved physical function, psychological function and social function. The economic burden for neck pain is very high.Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain.Recently, many studies have focused on specific training on deep cervical muscles, especially deep cervical flexor and deep cervical extensor muscles. The specific training on deep cervical muscles aims to improve control strategy, improve activation of deep cervical flexor muscles to optimize movement control of segmental motion of the cervical spine. Numerous studies using cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck disability, changing in activation of deep and superficial cervical flexor muscles. Further, the cervical extensor muscles are believed to be equally important for the rehabilitation of patients with neck pain. So, the activation of the deep cervical extensors should be emphasized for the management in people with neck pain. Schomacher et al (2012) suggested that isometric resisted exercise at the second cervical vertebra can improve semispinalis cervicis muscle activity in neck pain patients. However, the retention effect of semispinalis cervicis exercise is unknown. Therefore, the semispinalis cervicis exercise still need more evidence to support clinically effects. The current study will be conducted to fill the gap of the previous study in immediately, short, and long term effects of semispinalis cervicis exercise in chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- semispinalis cervicis resisted exercise, cranio-cervical flexion exercise, usual care
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semispinalis cervicis resisted exerciseOther
semispinalis cervicis resisted exercise, 2 time per week, 6 weeks duration
cranio-cervical flexion exerciseOther
cranio-cervical flexion exercise, 2 time per week, 6 weeks duration
usual careOther
usual care, 2 time per week, 6 weeks duration
| Study group | Role | What they receive |
|---|---|---|
| semispinalis cervicis resisted exercise | Experimental | semispinalis cervicis resisted exercise 2 times/week, 6 weeks duration Receives: Other: semispinalis cervicis resisted exercise |
| cranio-cervical flexion exercise | Experimental | cranio-cervical flexion exercise 2 times/week, 6 weeks duration Receives: Other: cranio-cervical flexion exercise |
| usual care | Active comparator | Usual care 2 times/week, 6 weeks duration Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: Up to 3-months after the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thavatchai Suvarnnato, Khon Kaen University
- Investigators
- Thavatchai Suvarnnato, M.Sc. PT, Principal investigator, Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656030
- Sponsor's protocol ID
- TSuvarnnato
- Status last verified
- Feb 2016
- First submitted
- 11 Jan 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Falla D, O'Leary S, Farina D, Jull G. The change in deep cervical flexor activity after training is associated with the degree of pain reduction in patients with chronic neck pain. Clin J Pain. 2012 Sep;28(7):628-34. doi: 10.1097/AJP.0b013e31823e9378.
PubMed 22156825Schomacher J, Petzke F, Falla D. Localised resistance selectively activates the semispinalis cervicis muscle in patients with neck pain. Man Ther. 2012 Dec;17(6):544-8. doi: 10.1016/j.math.2012.05.012. Epub 2012 Jun 22.
PubMed 22728210Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
PubMed 30881101
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Specific Training of Deep Cervical Muscles in Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02656030
- Acronym / sponsor ID
- TSuvarnnato
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- 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.
Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain.
Exercise is known to be an important component of treatment programs for patients with neck pain. Recently, many studies have focused on specific training on deep cervical muscles, especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck disability, changing in activation of deep cervical flexor muscles. Further, the cervical extensor muscles are believed to be equally important for the rehabilitation of patients with neck pain. However, the retention effect of semispinalis cervicis exercise is unknown. Therefore, the semispinalis cervicis exercise still need more evidence to support clinically effects.
The current study will be conducted to fill the gap of the previous study in immediately, short, and long term effects of semispinalis cervicis exercise in chronic neck pain.
Detailed description
Neck pain is a second the most common problems in musculoskeletal problems the low back pain in general population.The prevalence of neck pain at the some point in their lifetime in general population had been reported to be between 43 to 66.7 percent.the neck problems could be involved physical function, psychological function and social function. The economic burden for neck pain is very high.Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain.Recently, many studies have focused on specific training on deep cervical muscles, especially deep cervical flexor and deep cervical extensor muscles. The specific training on deep cervical muscles aims to improve control strategy, improve activation of deep cervical flexor muscles to optimize movement control of segmental motion of the cervical spine. Numerous studies using cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck disability, changing in activation of deep and superficial cervical flexor muscles. Further, the cervical extensor muscles are believed to be equally important for the rehabilitation of patients with neck pain. So, the activation of the deep cervical extensors should be emphasized for the management in people with neck pain. Schomacher et al (2012) suggested that isometric resisted exercise at the second cervical vertebra can improve semispinalis cervicis muscle activity in neck pain patients. However, the retention effect of semispinalis cervicis exercise is unknown. Therefore, the semispinalis cervicis exercise still need more evidence to support clinically effects. The current study will be conducted to fill the gap of the previous study in immediately, short, and long term effects of semispinalis cervicis exercise in chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| semispinalis cervicis resisted exercise | Experimental | Other: semispinalis cervicis resisted exercisesemispinalis cervicis resisted exercise 2 times/week, 6 weeks duration |
| cranio-cervical flexion exercise | Experimental | Other: cranio-cervical flexion exercisecranio-cervical flexion exercise 2 times/week, 6 weeks duration |
| usual care | Active comparator | Other: usual careUsual care 2 times/week, 6 weeks duration |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic mechanical neck pain
- Aged between 18 to 59 years
- The symptom more than three months in duration
- A baseline the Thai version of Neck Disability Index (NDI-TH) score of 10 percent or greater
Key exclusion criteria (5 listed)
- a previous history of whiplash injury
- a previous history injury to the cervical and thoracic spine
- diagnosed with osteoporosis, malignancy or other spinal inflection
- a positive vertebro-basilar artery insufficient test
- diagnosed with cervical radiculopathy and/or myelopathy
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 |
|---|---|---|
| semispinalis cervicis resisted exercisesemispinalis cervicis resisted exercise, 2 time per week, 6 weeks duration | Other | semispinalis cervicis resisted exercise |
| cranio-cervical flexion exercisecranio-cervical flexion exercise, 2 time per week, 6 weeks duration | Other | cranio-cervical flexion exercise |
| usual careusual care, 2 time per week, 6 weeks duration | Other | usual care |
Primary outcome
Neck Disability Index
Time frame: Up to 3-months after the last intervention session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Results publication: PubMed 22156825Falla D, O'Leary S, Farina D, Jull G. The change in deep cervical flexor activity after training is associated with the degree of pain reduction in patients with chronic neck pain. Clin J Pain. 2012 Sep;28(7):628-34. doi: 10.1097/AJP.0b013e31823e9378.
- Results publication: PubMed 22728210Schomacher J, Petzke F, Falla D. Localised resistance selectively activates the semispinalis cervicis muscle in patients with neck pain. Man Ther. 2012 Dec;17(6):544-8. doi: 10.1016/j.math.2012.05.012. Epub 2012 Jun 22.
- Derived from this study: PubMed 30881101Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Thavatchai Suvarnnato, M.Sc. PT contact
Thavatchai Suvarnnato, M.Sc. PT principal investigator
Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semispinalis cervicis resisted exercise and cranio-cervical flexion exercise in people with Neck Pain, run by Khon Kaen University at 1 site in Thailand.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2016. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thavatchai Suvarnnato, M.Sc. PT (+66890092175, suvarnnato@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Up to 3-months after the last intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656030, which also lists 3 linked publications.
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 15 Feb 2016.