Back PainNCT05821218
Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective
An observational study of Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2023to 23 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: Bahçeşehir University
Who may be able to join
- Volunteer
- 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
Show all 11Show fewer
- Cases without tumor and infection in the lumbar region
- Cases in which communication and cooperation are provided Exclusion criteria;
- Not having a musculoskeletal or neuromuscular disease that limits mobility,
- No upper extremity sequelae,
- Not volunteering
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
HAZAL genç
Istanbul, None Selected, 34353
HAZAL genç, phd, 05413204291, hazaloksuz@gmail.com
About this study
Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living.
Read the detailed description
The most common causes of low back pain are disc lesions and soft tissue injuries due to trauma, rheumatological disorders such as spondylosis, spinal stenosis and spondylolisthesis, ankylosing spondylitis and rheumatoid arthritis due to degenerative changes; osteoporosis, root disorders, and sacroiliac joint dysfunction
- Conditions
- Back Pain
- Keywords
- sacroiliac
- 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 | back pain group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Check Test
When a subject is lying prone or supine, emptying the pelvis, the feet are examined for the presence of a "short leg" or alignment asymmetry, often at the margin (heel-sole interface). Evidence has suggested that for most people, anatomical leg length disparity is not clinically relevant until the size reaches ~20 mm (~3/4"). It is a clinical test commonly used by chiropractors
Measured: 1 day
Pressure Pain Threshold Measurement with Algometer
Pressure algometry is a semi-quantitative method used to localize sensitive areas, trigger points, abnormal sensitivity on muscles and bones, and evaluate pressure pain sensitivity in tissues. The dial is calibrated to 2.5 kg in 25 g divisions. The pressure applied by continuously pressing the disc 35 against the skin is to advance the pointer on the dial clockwise through the metal piston.
Measured: 1 day
Oswestry Disability Index
Low back pain is one of the most common disorders that cause activity limitationIt has 16 questions and two subscales: physical activity and work. The physical activity section consists of 5 questions and the labor section consists of 11 questions. The questionnaire was a 7-point Likert type scale. In the answers given to the questionnaire, 0 points are given to the statement of "I don't agree at all" and 6 points to the statement of "I totally agree".
Measured: one day
Patrick FABER Test:
The ipsilateral hip and knee joint of the participant in the supine position was flexed, and the heel was placed on the opposite knee. The test stresses the anterior sacroiliac ligaments and hip joint. It was accepted that the pain was felt in the sacroiliac joint region
Measured: 1 day
Gaenslen Test
The participant was in the supine position on the examination table, with the lower extremity close to the evaluator hanging down from the bed, while the hip joint was brought to maximal hyperextension, while the hip and knee joints were passively brought to maximum flexion in the other lower extremity. The
Measured: 1 day
Compression Test
The participant was positioned on their side, hips flexed to 45° and knees flexed to 90°. The evaluator applied a compression force from the superior iliac crest to the lower iliac crest behind the patient. This test stretches the posterior sacroiliac ligaments and compresses the anterior portion of the sacroiliac joint. The test was considered positive if there was pain in the sacroiliac joint.
Measured: 1 day
The straight leg raise test
The straight leg raise test is known as the sciatic nerve stretch test. It has been reported that mobilization and stretching of the sciatic nerve occur from 30 degrees on.
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 posted20 Apr 2023
- Study start23 Apr 2023
- Primary completion23 Apr 2023
- Study completion23 Jul 2023 (estimated)
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Beken, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821218
- Sponsor's protocol ID
- Chiropractic Perspective
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective
- ClinicalTrials.gov ID
- NCT05821218
- Acronym / sponsor ID
- Chiropractic Perspective
- Conditions
- Back Pain
- Keywords
- sacroiliac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Jul 2023 (estimated)
- First posted
- 20 Apr 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.
Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living.
Detailed description
The most common causes of low back pain are disc lesions and soft tissue injuries due to trauma, rheumatological disorders such as spondylosis, spinal stenosis and spondylolisthesis, ankylosing spondylitis and rheumatoid arthritis due to degenerative changes; osteoporosis, root disorders, and sacroiliac joint dysfunction
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| back pain group | – | –back pain group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bahçeşehir University
Key inclusion criteria (11 listed)
- Volunteer
- 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
Key exclusion criteria (0 listed)
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
Leg Check Test
Time frame: 1 day
When a subject is lying prone or supine, emptying the pelvis, the feet are examined for the presence of a "short leg" or alignment asymmetry, often at the margin (heel-sole interface). Evidence has suggested that for most people, anatomical leg length disparity is not clinically relevant until the size reaches ~20 mm (~3/4"). It is a clinical test commonly used by chiropractors
Pressure Pain Threshold Measurement with Algometer
Time frame: 1 day
Pressure algometry is a semi-quantitative method used to localize sensitive areas, trigger points, abnormal sensitivity on muscles and bones, and evaluate pressure pain sensitivity in tissues. The dial is calibrated to 2.5 kg in 25 g divisions. The pressure applied by continuously pressing the disc 35 against the skin is to advance the pointer on the dial clockwise through the metal piston.
Oswestry Disability Index
Time frame: one day
Low back pain is one of the most common disorders that cause activity limitationIt has 16 questions and two subscales: physical activity and work. The physical activity section consists of 5 questions and the labor section consists of 11 questions. The questionnaire was a 7-point Likert type scale. In the answers given to the questionnaire, 0 points are given to the statement of "I don't agree at all" and 6 points to the statement of "I totally agree".
Patrick FABER Test:
Time frame: 1 day
The ipsilateral hip and knee joint of the participant in the supine position was flexed, and the heel was placed on the opposite knee. The test stresses the anterior sacroiliac ligaments and hip joint. It was accepted that the pain was felt in the sacroiliac joint region
Gaenslen Test
Time frame: 1 day
The participant was in the supine position on the examination table, with the lower extremity close to the evaluator hanging down from the bed, while the hip joint was brought to maximal hyperextension, while the hip and knee joints were passively brought to maximum flexion in the other lower extremity. The
Compression Test
Time frame: 1 day
The participant was positioned on their side, hips flexed to 45° and knees flexed to 90°. The evaluator applied a compression force from the superior iliac crest to the lower iliac crest behind the patient. This test stretches the posterior sacroiliac ligaments and compresses the anterior portion of the sacroiliac joint. The test was considered positive if there was pain in the sacroiliac joint.
The straight leg raise test
Time frame: 1 day
The straight leg raise test is known as the sciatic nerve stretch test. It has been reported that mobilization and stretching of the sciatic nerve occur from 30 degrees on.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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.
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 Bahçeşehir University 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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAZAL genç, PhD (05413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Check Test (time frame: 1 day). The study lists 7 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 25 Apr 2023.