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

October 5, 2022 updated by: Sureeporn Uthaikhup, Chiang Mai University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postural sway area
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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
Time Frame: Change from baseline at immediate, and 3, 6, 12 months follow-ups
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiang Mai University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Applied Sciences and Arts of Southern Switzerland
The University of Queensland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sureeporn Uthaikhup, Ph.D., Department of physical therapy, Chiang Mai university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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