Clinical trial NCT03149302: Effects of Local Treatment With and Without Sensorimotor and Balance Exercises in Neck Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Manual therapy
Sensorimotor exercises
Balance exercises
Cervical mobilization
Specific neck muscle exercises
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: The University of Queensland
name: University of Applied Sciences and Arts of Southern Switzerland
First posted: 2017-05-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: a 2 x 2 factorial blinded design
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postural sway area
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Postural sway displacement
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Cervical joint position error
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Secondary outcomes:
measure: Gait speed
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Dizziness intensity
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Neck pain intensity
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Neck pain disability
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Pain extent
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Pain location
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Cervical range of motion
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Functional ability status
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Health-related quality
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
measure: Global perceived benefit of treatment
timeFrame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Physical Therapy, Faculty of Associated Medical Sciences
Study officials:
affiliation: Department of physical therapy, Chiang Mai university
name: Sureeporn Uthaikhup, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Treleaven 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.
citation: Sremakaew 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.