Effects of Local Treatment With and Without Sensorimotor and Balance Exercises in Neck Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Local neck treatment (LNT)
* Other: LNT plus sensorimotor exercises
* Other: LNT plus balance exercises
* Other: LNT plus sensorimotor/balance exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 systemic conditions cognitive impairment taking four or more medications received physiotherapy treatment for their neck disorder in the past 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: a 2 x 2 factorial blinded design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local neck treatment (LNT)<br>Cervical mobilization and specific therapeutic exercises | Other: Local neck treatment (LNT)<br>* 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).<br>|
| Experimental: LNT plus sensorimotor exercises<br>Local neck treatment plus a tailored sensorimotor exercise program. | Other: LNT plus sensorimotor exercises<br>* 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).<br>|
| Experimental: LNT plus balance exercises<br>Local neck treatment plus balance training program. | Other: LNT plus balance exercises<br>* 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).<br>|
| Experimental: LNT plus sensorimotor/balance exercises<br>A combination of local neck treatment, sensorimotor control exercise, and balance exercise. | Other: LNT plus sensorimotor/balance exercises<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline at immediate, and 3, 6, 12 months follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Walk barefoot over 10 meters at a comfortable speed and then with head turns from side to side. | 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 | 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. | 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. | 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). | 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). | 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. | 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). | 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. | 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. | Change from baseline at immediate, and 3, 6, 12 months follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual therapy, Sensorimotor exercises, Balance exercises, Cervical mobilization, Specific neck muscle exercises