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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Local neck treatment (LNT)
LNT plus sensorimotor exercises
LNT plus balance exercises
LNT plus sensorimotor/balance exercises
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Manual therapy, Sensorimotor exercises, Balance exercises, Cervical mobilization, Specific neck muscle exercises

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Therapy, Faculty of Associated Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Local neck treatment (LNT)

LNT plus sensorimotor exercises

LNT plus balance exercises

LNT plus sensorimotor/balance exercises

Arm Description

Cervical mobilization and specific therapeutic exercises

Local neck treatment plus a tailored sensorimotor exercise program.

Local neck treatment plus balance training program.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Gait speed
Walk barefoot over 10 meters at a comfortable speed and then with head turns from side to side.
Dizziness intensity
an average dizziness intensity over the past week on VAS 0-10
Neck pain intensity
an average intensity of neck pain experienced in the past week on VAS 0-10.
Neck pain disability
How neck pain affects a patient's daily life and to assess the self-rated disability, using NDI.
Pain extent
Pain extent using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Pain location
Pain location using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Cervical range of motion
Cervical range of motion in flexion, extension, left-right lateral flexion and left-right rotation, using CROM.
Functional ability status
Participants' functional status using the patient-specific functional scale (PSFS).
Health-related quality
Participants' health-related quality of life, using Short Form-36.
Global perceived benefit of treatment
Participant rated perceived benefit of treatment, using a six-point ordinal Likert scale.

Full Information

First Posted
May 5, 2017
Last Updated
October 5, 2022
Sponsor
Chiang Mai University
Collaborators
The University of Queensland, University of Applied Sciences and Arts of Southern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03149302
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
Collaborators
The University of Queensland, University of Applied Sciences and Arts of Southern Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Manual therapy, Sensorimotor exercises, Balance exercises, Cervical mobilization, Specific neck muscle exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
a 2 x 2 factorial blinded design
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local neck treatment (LNT)
Arm Type
Experimental
Arm Description
Cervical mobilization and specific therapeutic exercises
Arm Title
LNT plus sensorimotor exercises
Arm Type
Experimental
Arm Description
Local neck treatment plus a tailored sensorimotor exercise program.
Arm Title
LNT plus balance exercises
Arm Type
Experimental
Arm Description
Local neck treatment plus balance training program.
Arm Title
LNT plus sensorimotor/balance exercises
Arm Type
Experimental
Arm Description
A combination of local neck treatment, sensorimotor control exercise, and balance exercise.
Intervention Type
Other
Intervention Name(s)
Local neck treatment (LNT)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
LNT plus sensorimotor exercises
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
LNT plus balance exercises
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
LNT plus sensorimotor/balance exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postural sway area
Description
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.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Postural sway displacement
Description
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.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Cervical joint position error
Description
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.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Secondary Outcome Measure Information:
Title
Gait speed
Description
Walk barefoot over 10 meters at a comfortable speed and then with head turns from side to side.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Dizziness intensity
Description
an average dizziness intensity over the past week on VAS 0-10
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Neck pain intensity
Description
an average intensity of neck pain experienced in the past week on VAS 0-10.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Neck pain disability
Description
How neck pain affects a patient's daily life and to assess the self-rated disability, using NDI.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Pain extent
Description
Pain extent using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Pain location
Description
Pain location using a digital device (iPad Air 2) and sketching software (SketchBook Pro).
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Cervical range of motion
Description
Cervical range of motion in flexion, extension, left-right lateral flexion and left-right rotation, using CROM.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Functional ability status
Description
Participants' functional status using the patient-specific functional scale (PSFS).
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Health-related quality
Description
Participants' health-related quality of life, using Short Form-36.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups
Title
Global perceived benefit of treatment
Description
Participant rated perceived benefit of treatment, using a six-point ordinal Likert scale.
Time Frame
Change from baseline at immediate, and 3, 6, 12 months follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sureeporn Uthaikhup, Ph.D.
Organizational Affiliation
Department of physical therapy, Chiang Mai university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Faculty of Associated Medical Sciences
City
Chiang Mai
ZIP/Postal Code
50202
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24792139
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.
Results Reference
background
PubMed Identifier
26678652
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.
Results Reference
background
PubMed Identifier
29433500
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.
Results Reference
derived

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

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