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Completed

NCT Number: NCT03149302

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, 50202, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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 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 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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Collaborators

  • The University of Queensland
  • University of Applied Sciences and Arts of Southern Switzerland

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 11, 2017
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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