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

Completed

• Conditions: Cervical Pain; Postural Balance
• Interventions: Other: neck pain and dual task

• Registration Number: NCT05338788
• Lead Sponsor: Bozyaka Training and Research Hospital

Brief 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.

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 Timeline

• Study Start: 2019-05-20
• Primary Completion: 2020-02-01
• Study Completion: 2022-03-20
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	neck pain and dual task	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.
Patient Group	neck pain and dual task	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disability level	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.

Trial Locations

Locations (1)

Hayriye Yılmaz; 🇹🇷 İzmir, Turkey