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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149302
• Other study ID #: Chiangmai university
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 24, 2021

Study information

• Verified date: October 2022
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
Thailand	Department of Physical Therapy, Faculty of Associated Medical Sciences	Chiang Mai

Sponsors (3)

Lead Sponsor	Collaborator
Chiang Mai University	The University of Queensland, University of Applied Sciences and Arts of Southern Switzerland

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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