Balance Performance in Dual Task in Patients With Cervical Disc Herniation Related Chronic Neck Pain:a Comparative Study

July 19, 2022 updated by: Bozyaka Training and Research Hospital

Balance Performance in Dual Task in Patients With Cervical Disc Herniation Related Chronic Neck Pain: a Comparative Study

Intense pain and moderate disability are seen most patients with symptomatic cervical disc herniation (CDH). Since neck motion and motor control are associated with changes in neck pain and disability, it is highly likely that patients with neck pain related disability would display dual-task interference (DTI) during postural control with a cognitive task.

It is very important for patients with cervical disk herniation to perform more than one task at the same time for many activities of daily living. Therefore, the aim of this study was to compare balance performance in dual task between patients with CDH related chronic neck pain and asymptomatic controls.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This study was designed cross-sectional controlled study. Thirty-two patients with CDH related chronic neck pain and twenty-three age and sex-matched asymptomatic controls participated in this study.

The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control. This system allows individuals to measure their stability limits. It also examines the control of the center of gravity on the support surface and balance abilities when trying to move it. The evaluated parameters of this system are presented below; modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task. Dual-task interference (DTI) was assessed.

In order to avoid the order bias of postural control measurements during "Single-task" and "Dual-task" for each case, the order of the measurements was determined by randomization on the first day by using sealed envelope method. After single/double task randomization was made, the order of tests was also randomized by using sealed envelopes containing two different orders (1-mCTSIB, 2-ASLT, 3-Fall test, 4-LOS and 1- LOS, 2- Fall test, 3- ASLT, 4-mCTSIB).

Before starting the evaluations, the participants were informed about the tests. Considering methodological bias, the same investigator performed all assessments and all participants received standardized and identical instructions.

Single and dual task measurements were made as follows:

Single task measurements involved the measurement of balance parameters by using Biodex Balance System without any additional cognitive task. For assessment of dual task performance, the participants were asked to perform an additional cognitive task (counting backwards from 200 by three or seven) during measurements .

DTI values were calculated for all balance parameters using the formulas below :

DTI %= (Dual Task-Single Task)/Single Task*100

Study Type

Observational

Enrollment (Actual)

55

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

      • İzmir, Turkey, 35110
        • Hayriye Yılmaz

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

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Between the ages of 18-64 men and women.

Description

Inclusion Criteria:

1.18 to 64 years of age 2.Having generalized neck pain for more than 3 months 3.Being literate and cooperative 4.Being volunteer 5.Volunteer patients diagnosed with chronic neck pain by a specialist

Inclusion criteria in the control group;

  1. Asymptomatic individuals between the ages of 18-64
  2. Without any known disease diagnosis and health problems that would affect the evaluations

Exclusion Criteria:

  1. Being pregnant,
  2. Malignancy,
  3. Having cervical stenosis,
  4. Severe cervical spondylosis,
  5. Cervical fractures and tumor,
  6. Osteoporosis,
  7. Neurologic deficit related to compression of the spinal root or cord,
  8. Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
  9. Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months

Exclusion criteria for the control group; People with cognitive, orthopaedic or neurological diseases that could negatively affect the evaluations

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Group

Thirty-two 32 patients with cervical disk herniation related chronic neck pain participated in this cross-sectional controlled study. Patients who aged 18-64 years, had neck pain for at least 12 weeks, no tumor, trauma, fracture pathology in the spinal region and no history of spine surgery were included.

The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control. The evaluated parameters of this system are presented below: modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task. Dual-task interference (DTI) was assessed.

The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System was used to assess postural control.Clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task.In order to avoid the order bias of postural control measurements during "Single-task" and "Dual-task" for each case, the order of the measurements was determined by randomization on the first day by using sealed envelope method. After single/double task randomization was made, the order of tests was also randomized by using sealed envelopes containing two different orders (1-mCTSIB, 2-ASLT, 3-Fall test, 4-LOS and 1- LOS, 2- Fall test, 3- ASLT, 4-mCTSIB).
Control Group

Twenty-three 23 age and sex-matched asymptomatic controls participated in this cross-sectional controlled study.

The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control.The evaluated parameters of this system are presented below: modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task. Dual-task interference (DTI)was assessed.

The Neck Disability Index (NDI) was used to assess neck pain related disability. The Biodex Balance System was used to assess postural control.Clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task.In order to avoid the order bias of postural control measurements during "Single-task" and "Dual-task" for each case, the order of the measurements was determined by randomization on the first day by using sealed envelope method. After single/double task randomization was made, the order of tests was also randomized by using sealed envelopes containing two different orders (1-mCTSIB, 2-ASLT, 3-Fall test, 4-LOS and 1- LOS, 2- Fall test, 3- ASLT, 4-mCTSIB).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Baseline
The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, New York, USA) was used to assess postural control.The evaluated parameters of this system are presented below:The modified clinical test of sensory integration of balance (mCTSIB), athletic single leg test (ASLT), limits of stability (LOS), and fall risk assessment were performed with and without a cognitive task.
Baseline
The modified Clinical Test of Sensory Integration of Balance (mCTSIB)
Time Frame: Baseline
The mCTSIB was used to assess individuals capability to use sensory inputs for balance.
Baseline
Athletic Single Leg Test (ASLT)
Time Frame: Baseline
The evaluation was made with eyes open and closed on one leg (dominant limb) on a firm floor on the balance device platform
Baseline
Limits of Stability (LOS):
Time Frame: Baseline
This test is the best test that measures dynamic control among the standard sway tests.
Baseline
Fall risk assessment
Time Frame: Baseline
The pre-test platform level was adjusted so that the starting position was 12 and the ending position was 8
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability level
Time Frame: Baseline
The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50.
Baseline

Collaborators and Investigators

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

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)

May 20, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

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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