Low Back PainNCT06073262
Investigation of Low Back Pain Level on Symptoms in Chronic Consipation
An observational study of Low Back Pain and Constipation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Consipation is the most common digestive complaint in the general population Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Constipation
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2023to 21 Dec 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
- Adult, Older adult
Study population: In this study, Rome III diagnostic criteria, which is the most commonly used diagnostic method, will be used to determine constipation status. According to the Rome III diagnostic criteria, the following symptoms must have been present for the last 3 months and these symptoms must have started at least 6 months before the diagnosis.
Who may be able to join
- 18-65 ages
- Rome III diagnostic criteria
Who cannot join
- Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as
- Multiple sclerosis, stroke, Parkinson's disease or spinal injury,
- Impaired awareness (mini-mental score < 15),
- Legal blindness, pregnancy,
- Rectal prolapse
- Anal fissure and altered constipation and diarrhea pattern.
Trial locations and contacts
1 site in 1 country.
gamze demircioğlu, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
HAZAL genç
Istanbul, None Selected, 34353
HAZAL genç, 05413204291, hazaloksuz@gmail.com
About this study
Official title: Investigation of the Effect of Low Back Pain Level on Symptoms in Individuals With Chronic Consipation
Consipation is the most common digestive complaint in the general population
Read the detailed description
Chronic constipation and low back pain are two common and often co-existing health conditions that affect millions of people worldwide. On the surface, these conditions appear to be unrelated and are associated with different anatomical sites (gastrointestinal tract and musculoskeletal system). However, a growing body of research is beginning to shed light on the complex interplay between chronic constipation and low back pain, highlighting potential links between these seemingly disparate health conditions. Common etiologic factors such as neuromuscular function, chronic inflammation and lifestyle-related variables are known to exist
- Conditions
- Low Back Pain, Constipation
- Keywords
- pain, Low Back Pain, Constipation
- Medical subject headings
- Low Back Pain, Constipation, 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 |
|---|---|---|
| Non-specific low back pain individual with chronic consipation | Not described | |
| Individual without low back pain with chronic consipation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Stool Scale
Lewis and Heaton classified the type of stool in 7 different groups in the scale. In the Bristol Stool Scale, the transit time of stool through the intestine is evaluated over seven different stool types. According to BGS, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool (diarrhea)".
Measured: one day
Pelvic Pain Impact Questionnaire
The questionnaire for clinical assessment of the impact of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of scores to be obtained from the questionnaire varies between 1- 32. As the score value to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person increases.
Measured: one day
Constipation Severity Scale
Constipation Severity Scale (CSS) is a scale for determining the frequency, intensity and difficulty/difficulty during defecation. The scale includes 16 questions.
The score that can be obtained from the DT sub-dimension is between 0-28, the score that can be obtained from the CBT sub-dimension is between 0-29, and the score that can be obtained from the Pain sub-dimension is between 0-16. The minimum total score that can be obtained from the KCS is 0 and the maximum score is 73. A high score on the scale indicates that the symptoms are serious. The highest score that can be obtained from the five-point Likert-type scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as the scores obtained from the scale increase
Measured: one day
Disability level
The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain (12). This index consists of 10 items, 8 related to activities of daily living and 2 related to pain. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to more disability). Increasing scores on the Oswestry Disability Index indicate a higher level of disability.
Measured: one day
Autonomic nervous system device (Polar H10)
The Polar H10 device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can connect to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that contacts the chest to capture heart rate in real time.
The study will evaluate the autonomic nervous system with the Polar H10 device. The data will be recorded by connecting the device to a smart phone via bluetooth and the software supported by the device will be used to analyze the data. The participant will be in a sitting position and a measurement will be made for 1 minute. In order for the device to make an accurate measurement, the electrode surface must be wetted before each measurement. The subject should not talk or move during the measurement.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Oct 2023
- Primary completion3 Oct 2023
- Study completion21 Dec 2023 (estimated)
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
- Other
- Time perspective
- Other
- Enrolment
- 52 participants (estimated)
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
- NCT06073262
- Sponsor's protocol ID
- E-10840098-772.02-5856
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Low Back Pain Level on Symptoms in Individuals With Chronic Consipation
- ClinicalTrials.gov ID
- NCT06073262
- Acronym / sponsor ID
- E-10840098-772.02-5856
- Conditions
- Low Back Pain, Constipation
- Keywords
- pain, Low Back Pain, Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 10 Oct 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.
Consipation is the most common digestive complaint in the general population
Detailed description
Chronic constipation and low back pain are two common and often co-existing health conditions that affect millions of people worldwide. On the surface, these conditions appear to be unrelated and are associated with different anatomical sites (gastrointestinal tract and musculoskeletal system). However, a growing body of research is beginning to shed light on the complex interplay between chronic constipation and low back pain, highlighting potential links between these seemingly disparate health conditions. Common etiologic factors such as neuromuscular function, chronic inflammation and lifestyle-related variables are known to exist
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specific low back pain individual with chronic consipation | – | – |
| Individual without low back pain with chronic consipation | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In this study, Rome III diagnostic criteria, which is the most commonly used diagnostic method, will be used to determine constipation status. According to the Rome III diagnostic criteria, the following symptoms must have been present for the last 3 months and these symptoms must have started at least 6 months before the diagnosis.
Key inclusion criteria (2 listed)
- 18-65 ages
- Rome III diagnostic criteria
Key exclusion criteria (6 listed)
- Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as
- Multiple sclerosis, stroke, Parkinson's disease or spinal injury,
- Impaired awareness (mini-mental score < 15),
- Legal blindness, pregnancy,
- Rectal prolapse
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
Bristol Stool Scale
Time frame: one day
Lewis and Heaton classified the type of stool in 7 different groups in the scale. In the Bristol Stool Scale, the transit time of stool through the intestine is evaluated over seven different stool types. According to BGS, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool (diarrhea)".
Pelvic Pain Impact Questionnaire
Time frame: one day
The questionnaire for clinical assessment of the impact of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of scores to be obtained from the questionnaire varies between 1- 32. As the score value to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person increases.
Constipation Severity Scale
Time frame: one day
Constipation Severity Scale (CSS) is a scale for determining the frequency, intensity and difficulty/difficulty during defecation. The scale includes 16 questions. The score that can be obtained from the DT sub-dimension is between 0-28, the score that can be obtained from the CBT sub-dimension is between 0-29, and the score that can be obtained from the Pain sub-dimension is between 0-16. The minimum total score that can be obtained from the KCS is 0 and the maximum score is 73. A high score on the scale indicates that the symptoms are serious. The highest score that can be obtained from the five-point Likert-type scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as the scores obtained from the scale increase
Disability level
Time frame: one day
The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain (12). This index consists of 10 items, 8 related to activities of daily living and 2 related to pain. Each item is scored from 0-5 and the total score is expressed as a percentage, with higher scores corresponding to more disability). Increasing scores on the Oswestry Disability Index indicate a higher level of disability.
Autonomic nervous system device (Polar H10)
Time frame: one day
The Polar H10 device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can connect to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that contacts the chest to capture heart rate in real time. The study will evaluate the autonomic nervous system with the Polar H10 device. The data will be recorded by connecting the device to a smart phone via bluetooth and the software supported by the device will be used to analyze the data. The participant will be in a sitting position and a measurement will be made for 1 minute. In order for the device to make an accurate measurement, the electrode surface must be wetted before each measurement. The subject should not talk or move during the measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
gamze demircioğlu, PhD contact
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 and Constipation, 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 2 inclusion and 6 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 10 Oct 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?
Bristol Stool Scale (time frame: one day). 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 10 Oct 2023.