NCT05338788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

April 5, 2022

Last Update Submit

July 19, 2022

Conditions

Keywords

Cervical Painpostural balanceBiodex Balance SystemCervical disc herniation

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Limits of Stability (LOS):

    This test is the best test that measures dynamic control among the standard sway tests.

    Baseline

  • 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 Outcomes (1)

  • Disability level

    Baseline

Study Arms (2)

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.

Other: neck pain and dual task

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.

Other: neck pain and dual task

Interventions

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 GroupPatient Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Between the ages of 18-64 men and women.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayriye Yılmaz

Izmir, 35110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet G KARAKAYA, Prof, PT

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 21, 2022

Study Start

May 20, 2019

Primary Completion

February 1, 2020

Study Completion

March 20, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations