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

Cervical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338788
• Other study ID #: IzmirBozyaka-HayriyeYILMAZ-001
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: March 20, 2022

Study information

• Verified date: July 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 20, 2022
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Pain
• Hernia
• Intervertebral Disc Displacement
• Neck Pain
• Postural Balance

Intervention

Other:
• neck pain and dual task
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).

Locations

Country	Name	City	State
Turkey	Hayriye Yilmaz	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance	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
Primary	The modified Clinical Test of Sensory Integration of Balance (mCTSIB)	The mCTSIB was used to assess individuals capability to use sensory inputs for balance.	Baseline
Primary	Athletic Single Leg Test (ASLT)	The evaluation was made with eyes open and closed on one leg (dominant limb) on a firm floor on the balance device platform	Baseline
Primary	Limits of Stability (LOS):	This test is the best test that measures dynamic control among the standard sway tests.	Baseline
Primary	Fall risk assessment	The pre-test platform level was adjusted so that the starting position was 12 and the ending position was 8	Baseline
Secondary	Disability level	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