Neck PainNCT03149302
Effects of Local Treatment With and Without Sensorimotor and Balance Exercises in Neck Pain
A study testing Local neck treatment (LNT), LNT plus sensorimotor exercises and LNT plus balance exercises in people with Neck Pain, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The sensorimotor disturbance and postural instability have been demonstrated to be associated with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Local neck treatment (LNT), LNT plus sensorimotor exercises and LNT plus balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2018to 24 Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- insidious neck pain for at least 3 months
- an average neck pain intensity over the past week ≥ 30 mm on a 100 mm visual analog scale (VAS)
- a score of neck pain and disability ≥ 10/ 100 on the Neck Disability Index-Thai version
- an absolute error of cervical joint position error > 4.5°
- an inability to stand in tandem stance with eyes closed for 30 seconds
- cervical segmental joint dysfunction (pain provoked >2/10 with abnormal tissue resistance)
Who cannot join
- a previous history of neck and head injury or surgery
- known or suspected vestibular pathology
- vertigo or dizziness caused by underlying pathology in the ear, brain, or sensory nerve pathways (e.g. benign paroxysmal positional vertigo and BPPV)
- vascular disorders (e.g. a migraine and hypertension)
- any musculoskeletal or neurological conditions that could affect a balance
- inflammatory joint disease
Show all 10Show fewer
- systemic conditions
- cognitive impairment
- taking four or more medications
- received physiotherapy treatment for their neck disorder in the past 12 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Physical Therapy, Faculty of Associated Medical Sciences
Chiang Mai, 50202
About this study
Official title: Effects of Local Neck Treatment With and Without Tailored Sensorimotor Control and Balance Exercises for Individuals With Chronic Neck Pain: Protocol for a Randomized Controlled Trial
The sensorimotor disturbance and postural instability have been demonstrated to be associated with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed.
Read the detailed description
The sensorimotor (joint position sense and oculomotor control) and postural stability (balance) disturbances have been demonstrated to be associated with neck pain. Specific therapeutic exercise directed to neuromuscular impairments and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed. Currently, it is not known whether the clinician has to train every impairment or can choose between sensorimotor training and balance training in the rehabilitation of neck pain. Different training approaches may have specific influences on the different outcomes and their outcomes will be important to inform the optimal and efficient management of persons with chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- Local neck treatment (LNT), LNT plus sensorimotor exercises, LNT plus balance exercises, LNT plus sensorimotor/balance exercises
- Keywords
- Manual therapy, Sensorimotor exercises, Balance exercises, Cervical mobilization, Specific neck muscle exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local neck treatment (LNT)Other
The local neck treatment consists of cervical mobilization and specific therapeutic exercises (30 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
LNT plus sensorimotor exercisesOther
The local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes). The sensorimotor exercises include cervical joint position sense and oculomotor training. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
LNT plus balance exercisesOther
The local neck treatment (30 minutes) plus the balance exercise program (15 minutes).The balance program includes with static balance and progress to dynamic balance and gait. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
LNT plus sensorimotor/balance exercisesOther
The local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes) and the balance exercises (15 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Local neck treatment (LNT) | Experimental | Cervical mobilization and specific therapeutic exercises Receives: Other: Local neck treatment (LNT) |
| LNT plus sensorimotor exercises | Experimental | Local neck treatment plus a tailored sensorimotor exercise program. Receives: Other: LNT plus sensorimotor exercises |
| LNT plus balance exercises | Experimental | Local neck treatment plus balance training program. Receives: Other: LNT plus balance exercises |
| LNT plus sensorimotor/balance exercises | Experimental | A combination of local neck treatment, sensorimotor control exercise, and balance exercise. Receives: Other: LNT plus sensorimotor/balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway area
The sway area during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Postural sway displacement
The sway displacement during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Cervical joint position error
The ability to perform an active movement (extension and rotation to the left and right) and return to the starting head position as accurately as possible, using a target on the wall and a laser-pointer attached to a lightweight headband.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Secondary outcomes (10)
Gait speed
Walk barefoot over 10 meters at a comfortable speed and then with head turns from side to side.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Dizziness intensity
an average dizziness intensity over the past week on VAS 0-10
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Neck pain intensity
an average intensity of neck pain experienced in the past week on VAS 0-10.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Neck pain disability
How neck pain affects a patient's daily life and to assess the self-rated disability, using NDI.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Pain extent
Pain extent using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Pain location
Pain location using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Cervical range of motion
Cervical range of motion in flexion, extension, left-right lateral flexion and left-right rotation, using CROM.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Functional ability status
Participants' functional status using the patient-specific functional scale (PSFS).
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Health-related quality
Participants' health-related quality of life, using Short Form-36.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Global perceived benefit of treatment
Participant rated perceived benefit of treatment, using a six-point ordinal Likert scale.
Measured: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Nov 2018
- Primary completion24 Dec 2020
- Study completion24 Dec 2021
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
- Factorial
- Model description
- a 2 x 2 factorial blinded design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland, University of Applied Sciences and Arts of Southern Switzerland
- Responsible party
- Principal investigator, Sureeporn Uthaikhup, Chiang Mai University
- Investigators
- Sureeporn Uthaikhup, Ph.D., Principal investigator, Department of physical therapy, Chiang Mai university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149302
- Sponsor's protocol ID
- Chiangmai university
- Status last verified
- Oct 2022
- First submitted
- 5 May 2017
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
PubMed 24792139Treleaven J, Peterson G, Ludvigsson ML, Kammerlind AS, Peolsson A. Balance, dizziness and proprioception in patients with chronic whiplash associated disorders complaining of dizziness: A prospective randomized study comparing three exercise programs. Man Ther. 2016 Apr;22:122-30. doi: 10.1016/j.math.2015.10.017. Epub 2015 Nov 26.
PubMed 26678652Sremakaew M, Jull G, Treleaven J, Barbero M, Falla D, Uthaikhup S. Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Feb 13;19(1):48. doi: 10.1186/s12891-018-1964-3.
PubMed 29433500
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Neck Treatment With and Without Tailored Sensorimotor Control and Balance Exercises for Individuals With Chronic Neck Pain: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03149302
- Acronym / sponsor ID
- Chiangmai university
- Conditions
- Neck Pain
- Keywords
- Manual therapy, Sensorimotor exercises, Balance exercises, Cervical mobilization, Specific neck muscle exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- The University of Queensland, University of Applied Sciences and Arts of Southern Switzerland
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 11 May 2017 (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.
The sensorimotor disturbance and postural instability have been demonstrated to be associated with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed.
Detailed description
The sensorimotor (joint position sense and oculomotor control) and postural stability (balance) disturbances have been demonstrated to be associated with neck pain. Specific therapeutic exercise directed to neuromuscular impairments and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed. Currently, it is not known whether the clinician has to train every impairment or can choose between sensorimotor training and balance training in the rehabilitation of neck pain. Different training approaches may have specific influences on the different outcomes and their outcomes will be important to inform the optimal and efficient management of persons with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- a 2 x 2 factorial blinded design
| Arm | Type | Receives |
|---|---|---|
| Local neck treatment (LNT) | Experimental | Other: Local neck treatment (LNT)Cervical mobilization and specific therapeutic exercises |
| LNT plus sensorimotor exercises | Experimental | Other: LNT plus sensorimotor exercisesLocal neck treatment plus a tailored sensorimotor exercise program. |
| LNT plus balance exercises | Experimental | Other: LNT plus balance exercisesLocal neck treatment plus balance training program. |
| LNT plus sensorimotor/balance exercises | Experimental | Other: LNT plus sensorimotor/balance exercisesA combination of local neck treatment, sensorimotor control exercise, and balance exercise. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- insidious neck pain for at least 3 months
- an average neck pain intensity over the past week ≥ 30 mm on a 100 mm visual analog scale (VAS)
- a score of neck pain and disability ≥ 10/ 100 on the Neck Disability Index-Thai version
- an absolute error of cervical joint position error > 4.5°
- an inability to stand in tandem stance with eyes closed for 30 seconds
Key exclusion criteria (10 listed)
- a previous history of neck and head injury or surgery
- known or suspected vestibular pathology
- vertigo or dizziness caused by underlying pathology in the ear, brain, or sensory nerve pathways (e.g. benign paroxysmal positional vertigo and BPPV)
- vascular disorders (e.g. a migraine and hypertension)
- any musculoskeletal or neurological conditions that could affect a balance
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 |
|---|---|---|
| Local neck treatment (LNT)The local neck treatment consists of cervical mobilization and specific therapeutic exercises (30 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks). | Other | Local neck treatment (LNT) |
| LNT plus sensorimotor exercisesThe local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes). The sensorimotor exercises include cervical joint position sense and oculomotor training. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks). | Other | LNT plus sensorimotor exercises |
| LNT plus balance exercisesThe local neck treatment (30 minutes) plus the balance exercise program (15 minutes).The balance program includes with static balance and progress to dynamic balance and gait. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks). | Other | LNT plus balance exercises |
| LNT plus sensorimotor/balance exercisesThe local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes) and the balance exercises (15 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks). | Other | LNT plus sensorimotor/balance exercises |
Primary outcome
Postural sway area
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
The sway area during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.
Postural sway displacement
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
The sway displacement during narrow stance on firm and soft surfaces with eyes open and eyes closed and during neck torsion maneuver (head turned 45 degrees to the left and right) on firm and soft surfaces, using a swaymeter device.
Cervical joint position error
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
The ability to perform an active movement (extension and rotation to the left and right) and return to the starting head position as accurately as possible, using a target on the wall and a laser-pointer attached to a lightweight headband.
10 secondary outcomes
Gait speed
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Dizziness intensity
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Neck pain intensity
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Neck pain disability
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Pain extent
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Pain location
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Cervical range of motion
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Functional ability status
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Health-related quality
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Global perceived benefit of treatment
Time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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 6 Oct 2022.
- Background: PubMed 24792139Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
- Background: PubMed 26678652Treleaven J, Peterson G, Ludvigsson ML, Kammerlind AS, Peolsson A. Balance, dizziness and proprioception in patients with chronic whiplash associated disorders complaining of dizziness: A prospective randomized study comparing three exercise programs. Man Ther. 2016 Apr;22:122-30. doi: 10.1016/j.math.2015.10.017. Epub 2015 Nov 26.
- Derived from this study: PubMed 29433500Sremakaew M, Jull G, Treleaven J, Barbero M, Falla D, Uthaikhup S. Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Feb 13;19(1):48. doi: 10.1186/s12891-018-1964-3.
- Individual participant dataSharing planned: No
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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.
Sureeporn Uthaikhup, Ph.D. principal investigator
Department of physical therapy, Chiang Mai 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 Local neck treatment (LNT), LNT plus sensorimotor exercises and LNT plus balance exercises in people with Neck Pain, run by Chiang Mai 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 6 inclusion and 10 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 6 Oct 2022. 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?
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?
Postural sway area (time frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups). The study lists 3 primary outcomes in all. 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 NCT03149302, 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 6 Oct 2022.