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

NCT03149302 | Completed

• 1 other identifier: Chiangmai university
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

Manual therapy; Sensorimotor exercises; Balance exercises; Cervical mobilization; Specific neck muscle exercises

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Gait speed

  Change from baseline at immediate, and 3, 6, 12 months follow-ups

• Dizziness intensity

  Change from baseline at immediate, and 3, 6, 12 months follow-ups

• Neck pain intensity

  Change from baseline at immediate, and 3, 6, 12 months follow-ups

• Neck pain disability

  Change from baseline at immediate, and 3, 6, 12 months follow-ups

• Pain extent

  Change from baseline at immediate, and 3, 6, 12 months follow-ups

Study Arms (4)

Local neck treatment (LNT)

EXPERIMENTAL

Cervical mobilization and specific therapeutic exercises

Other: Local neck treatment (LNT)

LNT plus sensorimotor exercises

EXPERIMENTAL

Local neck treatment plus a tailored sensorimotor exercise program.

Other: LNT plus sensorimotor exercises

LNT plus balance exercises

EXPERIMENTAL

Local neck treatment plus balance training program.

Other: LNT plus balance exercises

LNT plus sensorimotor/balance exercises

EXPERIMENTAL

A combination of local neck treatment, sensorimotor control exercise, and balance exercise.

Other: LNT plus sensorimotor/balance exercises

Interventions

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).

Local neck treatment (LNT)

LNT plus sensorimotor exercises OTHER

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 sensorimotor exercises

LNT plus balance exercises OTHER

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 balance exercises

LNT plus sensorimotor/balance exercises OTHER

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).

LNT plus sensorimotor/balance exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead
• The University of Queensland: collaborator
• University of Applied Sciences and Arts of Southern Switzerland: collaborator

Study Sites (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, 50202, Thailand

Location

Related Publications (3)

• 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.

  PMID: 24792139 BACKGROUND

• 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.

  PMID: 26678652 BACKGROUND

• 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.

  PMID: 29433500 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sureeporn Uthaikhup, Ph.D.

  Department of physical therapy, Chiang Mai university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a 2 x 2 factorial blinded design

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: November 1, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2021
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)