Low Back PainNCT07106905
Low Back Pain in Mothers of Children With Disabilities
An observational study of Low Back Pain, run by Selvin BALKİ at 1 site in Turkey (Türkiye).
Trial summary
This is a cross-sectional study that aims to determine the prevalence of low back pain in mothers of children with disabilities following the COVID-19 pandemic and to describe its relationship with exposure to the virus, handgrip strength, physical workload, and depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Measurements
- How many people
- 179 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2021to 8 Sep 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mothers of Children with Disabilities
Who may be able to join
- Volunteering to participate in the study
- Having a disabled child
- Being responsible for the care of a disabled child
- Having provided care for a disabled child for at least one year
Who cannot join
- Having more than one disabled child and being responsible for their care
- Having previously undergone surgery on the lower back
- Having a previous upper extremity disorder
- Receiving psychological treatment or medication
- Being pregnant or having recently given birth
- Having a recent history of trauma to the musculoskeletal system
- Having a defined chronic illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sivas Cumhuriyet University
Sivas, 58140
About this study
Official title: Relationships Between Handgrip Strength, Physical Workload, Depression, and Low Back Pain in Mothers of Children With Disabilities Following COVID-19 Pandemic
This is a cross-sectional study that aims to determine the prevalence of low back pain in mothers of children with disabilities following the COVID-19 pandemic and to describe its relationship with exposure to the virus, handgrip strength, physical workload, and depression.
Read the detailed description
Low back pain is a very common problem in mothers of children with disabilities. Musculoskeletal pain have been on the rise with COVID-19 but the effects of the pandemic on the prevalence of low back pain in mothers of children with disabilities have not been investigated. The relationship between handgrip strength and low back pain is well known. There are limited studies investigating handgrip strength or muscle strength in mothers of children with disabilities, and no studies examining the relationship between handgrip strength and low back pain.
- Conditions
- Low Back Pain
- Being tested
- Measurements
- Keywords
- Low back pain, Mothers of children with disabilities., Handgrip strength, Physical workload, Depression
- Medical subject headings
- Low Back Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsOther
These measurements are used in other clinical applications. However, the effectiveness of these measurements in discriminating the presence of low back pain in mothers of children with disabilities over the past year has been identified.
| Study group | Role | What they receive |
|---|---|---|
| Mothers of children with disabilities | Not described Receives: Other: Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Beck Depression Inventory
It is a scale consisting of 21 items that measures depressive symptoms. A maximum of 63 points can be obtained, with higher scores indicating an increase in depression.
Measured: Baseline
Physical Workload Questionnaire
A 19-item Likert scale with scores ranging from 0 to 4, developed to identify the load on the lumbar region during work activities. Higher scores indicate increased work load.
Measured: Baseline
Handgrip strength measurement
This measurement was performed on the dominant hand while the participant was seated in a chair in the standard position defined by the American Hand Therapy Association. They were asked to squeeze the dynamometer as hard as possible. The average of three measurements taken at 30-second intervals was recorded in pounds.
Measured: Baseline
Secondary outcomes (1)
1-10 Numerical Pain Rating Scale (NPRS)
The NPRS was used to determine the severity of low back pain reported at the time of assessment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Nov 2021
- Primary completion1 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selvin BALKİ
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Sponsor-investigator, Selvin BALKİ, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106905
- Sponsor's protocol ID
- SCU-FTR-SBF-02
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Handgrip Strength, Physical Workload, Depression, and Low Back Pain in Mothers of Children With Disabilities Following COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT07106905
- Acronym / sponsor ID
- SCU-FTR-SBF-02
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Mothers of children with disabilities., Handgrip strength, Physical workload, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Selvin BALKİUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 6 Aug 2025 (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.
This is a cross-sectional study that aims to determine the prevalence of low back pain in mothers of children with disabilities following the COVID-19 pandemic and to describe its relationship with exposure to the virus, handgrip strength, physical workload, and depression.
Detailed description
Low back pain is a very common problem in mothers of children with disabilities. Musculoskeletal pain have been on the rise with COVID-19 but the effects of the pandemic on the prevalence of low back pain in mothers of children with disabilities have not been investigated. The relationship between handgrip strength and low back pain is well known. There are limited studies investigating handgrip strength or muscle strength in mothers of children with disabilities, and no studies examining the relationship between handgrip strength and low back pain.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers of children with disabilities | – | Other: Measurements |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mothers of Children with Disabilities
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- Having a disabled child
- Being responsible for the care of a disabled child
- Having provided care for a disabled child for at least one year
Key exclusion criteria (7 listed)
- Having more than one disabled child and being responsible for their care
- Having previously undergone surgery on the lower back
- Having a previous upper extremity disorder
- Receiving psychological treatment or medication
- Being pregnant or having recently given birth
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 |
|---|---|---|
| MeasurementsThese measurements are used in other clinical applications. However, the effectiveness of these measurements in discriminating the presence of low back pain in mothers of children with disabilities over the past year has been identified. | Other | Mothers of children with disabilities |
Primary outcome
. Beck Depression Inventory
Time frame: Baseline
It is a scale consisting of 21 items that measures depressive symptoms. A maximum of 63 points can be obtained, with higher scores indicating an increase in depression.
Physical Workload Questionnaire
Time frame: Baseline
A 19-item Likert scale with scores ranging from 0 to 4, developed to identify the load on the lumbar region during work activities. Higher scores indicate increased work load.
Handgrip strength measurement
Time frame: Baseline
This measurement was performed on the dominant hand while the participant was seated in a chair in the standard position defined by the American Hand Therapy Association. They were asked to squeeze the dynamometer as hard as possible. The average of three measurements taken at 30-second intervals was recorded in pounds.
1 secondary outcome
1-10 Numerical Pain Rating Scale (NPRS)
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 6 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Back Pain, run by Selvin BALKİ 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 4 inclusion and 7 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 6 Aug 2025. 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?
. Beck Depression Inventory (time frame: Baseline). The study lists 3 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 6 Aug 2025.