Cervical PainNCT05338788
Balance Performance in Dual Task in Patients With Cervical Disc Herniation Related Chronic Neck Pain:a Comparative Study
An observational study of Cervical Pain and Postural Balance, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain, Postural Balance
- What is being tested?
- neck pain and dual task
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 20 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Between the ages of 18-64 men and women.
Who may be able to join
- 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
- Asymptomatic individuals between the ages of 18-64
- Without any known disease diagnosis and health problems that would affect the evaluations
Who cannot join
- Being pregnant,
- Malignancy,
- Having cervical stenosis,
- Severe cervical spondylosis,
- Cervical fractures and tumor,
- Osteoporosis,
Show all 10Show fewer
- 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
- Exclusion criteria for the control group; People with cognitive, orthopaedic or neurological diseases that could negatively affect the evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Cervical Pain, Postural Balance
- Being tested
- neck pain and dual task
- Keywords
- Cervical Pain, postural balance, Biodex Balance System, Cervical disc herniation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck pain and dual taskOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: neck pain and dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline
Limits of Stability (LOS):
This test is the best test that measures dynamic control among the standard sway tests.
Measured: Baseline
Fall risk assessment
The pre-test platform level was adjusted so that the starting position was 12 and the ending position was 8
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start20 May 2019
- Primary completion1 Feb 2020
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet G KARAKAYA, Prof, PT, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338788
- Sponsor's protocol ID
- IzmirBozyaka-HayriyeYILMAZ-001
- Status last verified
- Jul 2022
- First submitted
- 5 Apr 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Performance in Dual Task in Patients With Cervical Disc Herniation Related Chronic Neck Pain: a Comparative Study
- ClinicalTrials.gov ID
- NCT05338788
- Acronym / sponsor ID
- IzmirBozyaka-HayriyeYILMAZ-001
- Conditions
- Cervical Pain, Postural Balance
- Keywords
- Cervical Pain, postural balance, Biodex Balance System, Cervical disc herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Other: neck pain and dual taskThirty-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. |
| Control Group | – | Other: neck pain and dual taskTwenty-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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Between the ages of 18-64 men and women.
Key inclusion criteria (3 listed)
- 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
- Asymptomatic individuals between the ages of 18-64
- Without any known disease diagnosis and health problems that would affect the evaluations
Key exclusion criteria (10 listed)
- Being pregnant,
- Malignancy,
- Having cervical stenosis,
- Severe cervical spondylosis,
- Cervical fractures and tumor,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neck pain and dual taskThe 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). | Other | Control Group, Patient Group |
Primary outcome
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.
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.
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
Limits of Stability (LOS):
Time frame: Baseline
This test is the best test that measures dynamic control among the standard sway tests.
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
1 secondary outcome
Disability level
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet G KARAKAYA, Prof, PT study director
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pain and Postural Balance, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.