Back PainNCT05982964
Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain
An observational study of Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2023to 15 Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study was carried out on healthy and non-specific low back pain individuals who came to Bahçeşehir University.
Who may be able to join
- Individuals between the ages of 18-65
- Individuals with low back pain for at least 3 months for the first group
- Not undergoing surgery related to the lumbar region
- Cases without lumbar steroid injection in the last 3 months
- Not having visual and hearing loss
- Having low back pain
- Cases without neurological problems
- Cases without tumor and infection in the lumbar region
Who cannot join
- Individuals under the age of 18
- Individuals with low back pain for less than 3 months for the first group
- Not having a musculoskeletal or neuromuscular disease that limits mobility,
Trial locations and contacts
1 site in 1 country.
About this study
Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.
Read the detailed description
Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.
- Conditions
- Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| back pain group | Not described | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold Algometer
The pressure algometer is a tool used to assess the pain threshold. The algometer used in this study is connected to a dial measuring the pressure in kilograms and pounds, and consists of a metal piston with a diameter of 1 centimeter at the tip, the smallest gap of which is 100 gr and 10 kg/cm².
Measured: 1 day
Examining the Scapular Position
The lateral scapular glide test was used to evaluate the scapula position. In the first position, the arms were relaxed at the sides, the shoulder was in the neutral position, in the second position the patient's hands were positioned around the waist and the humerus was brought to medial rotation and abduction of 45 degrees, and in the third position, the humerus was placed in maximal medial rotation and 90-degree abduction.
Measured: 1 day
Evaluation of Balance
The static and dynamic postural stability of all individuals included in the study were evaluated with the Biodex Balance System (BDS).
For dynamic stability measurement, a total of 3 tests were conducted, with the platform in dynamic position, with each period lasting 20 seconds, giving the participant a rest period of 10 seconds in between. Afterwards, the average of these 3 tests was obtained automatically by the device. In the results obtained, it is possible to interpret that as the score approaches 0, the balance is maintained, and as it moves away from 0, the balance is deteriorated.
Measured: 1 day
Proprioception Evaluation
An inclinometer is an instrument that records angular movements with respect to gravity. The inclinometer has many advantages such as precise measurement, digital display, and ease of use.
In our study, inclinometer was used in the evaluation of proprioception. Measurements will be recorded in degrees.
Measured: 1 day
Evaluation of Functionality
The Oswestry Low Back Pain Disability Questionnaire (OBAEA) was used to examine functionality in patients with chronic low back pain. This survey consists of 10 questions in total. Each question has 6 options and ranges from 0 to 5. Participants are asked to mark the option that best fits their individual situation. While 50 is the highest score, it is evaluated as mild functional disability between 1 and 10 points, moderate functional disability between 11 and 30 points, and severe functional disability between 31 and 50 points.
Measured: 1 day
Waist Awareness Assessment
Fremantle Waist Awareness Questionnaire was used to evaluate low back awareness in the study. The Fremantle Waist Awareness Questionnaire is the only one that assesses body awareness about the waist. It consists of 9 questions in total and each question has a score ranging from 0-4. In total, the lowest 0 and the highest 36 points can be obtained. High scores indicate low back awareness.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start31 Jul 2023
- Primary completion31 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Other
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982964
- Sponsor's protocol ID
- E-85646034-604.02.02-62452
- Status last verified
- Dec 2024
- First submitted
- 31 Jul 2023
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05982964
- Acronym / sponsor ID
- E-85646034-604.02.02-62452
- Conditions
- Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 9 Aug 2023 (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.
Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.
Detailed description
Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| back pain group | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our study was carried out on healthy and non-specific low back pain individuals who came to Bahçeşehir University.
Key inclusion criteria (8 listed)
- Individuals between the ages of 18-65
- Individuals with low back pain for at least 3 months for the first group
- Not undergoing surgery related to the lumbar region
- Cases without lumbar steroid injection in the last 3 months
- Not having visual and hearing loss
Key exclusion criteria (3 listed)
- Individuals under the age of 18
- Individuals with low back pain for less than 3 months for the first group
- Not having a musculoskeletal or neuromuscular disease that limits mobility,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure Pain Threshold Algometer
Time frame: 1 day
The pressure algometer is a tool used to assess the pain threshold. The algometer used in this study is connected to a dial measuring the pressure in kilograms and pounds, and consists of a metal piston with a diameter of 1 centimeter at the tip, the smallest gap of which is 100 gr and 10 kg/cm².
Examining the Scapular Position
Time frame: 1 day
The lateral scapular glide test was used to evaluate the scapula position. In the first position, the arms were relaxed at the sides, the shoulder was in the neutral position, in the second position the patient's hands were positioned around the waist and the humerus was brought to medial rotation and abduction of 45 degrees, and in the third position, the humerus was placed in maximal medial rotation and 90-degree abduction.
Evaluation of Balance
Time frame: 1 day
The static and dynamic postural stability of all individuals included in the study were evaluated with the Biodex Balance System (BDS). For dynamic stability measurement, a total of 3 tests were conducted, with the platform in dynamic position, with each period lasting 20 seconds, giving the participant a rest period of 10 seconds in between. Afterwards, the average of these 3 tests was obtained automatically by the device. In the results obtained, it is possible to interpret that as the score approaches 0, the balance is maintained, and as it moves away from 0, the balance is deteriorated.
Proprioception Evaluation
Time frame: 1 day
An inclinometer is an instrument that records angular movements with respect to gravity. The inclinometer has many advantages such as precise measurement, digital display, and ease of use. In our study, inclinometer was used in the evaluation of proprioception. Measurements will be recorded in degrees.
Evaluation of Functionality
Time frame: 1 day
The Oswestry Low Back Pain Disability Questionnaire (OBAEA) was used to examine functionality in patients with chronic low back pain. This survey consists of 10 questions in total. Each question has 6 options and ranges from 0 to 5. Participants are asked to mark the option that best fits their individual situation. While 50 is the highest score, it is evaluated as mild functional disability between 1 and 10 points, moderate functional disability between 11 and 30 points, and severe functional disability between 31 and 50 points.
Waist Awareness Assessment
Time frame: 1 day
Fremantle Waist Awareness Questionnaire was used to evaluate low back awareness in the study. The Fremantle Waist Awareness Questionnaire is the only one that assesses body awareness about the waist. It consists of 9 questions in total and each question has a score ranging from 0-4. In total, the lowest 0 and the highest 36 points can be obtained. High scores indicate low back awareness.
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 27 Dec 2024.
- 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.
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 Back Pain, run by Istanbul Medipol University 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 8 inclusion and 3 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 27 Dec 2024. 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?
Pressure Pain Threshold Algometer (time frame: 1 day). The study lists 6 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 27 Dec 2024.