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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149302
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : October 6, 2022
Sponsor:
Collaborators:
The University of Queensland
University of Applied Sciences and Arts of Southern Switzerland
Information provided by (Responsible Party):
Sureeporn Uthaikhup, Chiang Mai University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Local neck treatment (LNT) Other: LNT plus sensorimotor exercises Other: LNT plus balance exercises Other: LNT plus sensorimotor/balance exercises Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: a 2 x 2 factorial blinded design
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : December 24, 2020
Actual Study Completion Date : December 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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).

  9. 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.

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149302


Locations
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Thailand
Department of Physical Therapy, Faculty of Associated Medical Sciences
Chiang Mai, Thailand, 50202
Sponsors and Collaborators
Chiang Mai University
The University of Queensland
University of Applied Sciences and Arts of Southern Switzerland
Investigators
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Principal Investigator: Sureeporn Uthaikhup, Ph.D. Department of physical therapy, Chiang Mai university
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sureeporn Uthaikhup, Principal Investigator, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03149302    
Other Study ID Numbers: Chiangmai university
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sureeporn Uthaikhup, Chiang Mai University:
Manual therapy
Sensorimotor exercises
Balance exercises
Cervical mobilization
Specific neck muscle exercises
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations