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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Local neck treatment (LNT); Other: LNT plus sensorimotor exercises; Other: LNT plus balance exercises; Other: LNT plus sensorimotor/balance exercises

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50202
    • Department of Physical Therapy, Faculty of Associated Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Collaborators: University of Applied Sciences and Arts of Southern Switzerland; The University of Queensland
• Investigators: Principal Investigator: Sureeporn Uthaikhup, Ph.D., Department of physical therapy, Chiang Mai university

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Manual therapy; Sensorimotor exercises; Balance exercises; Cervical mobilization; Specific neck muscle exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Chiangmai university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No