Bariatric SurgeryNCT03460691
The Effect of Bariatric Surgery to Central Sensitization
An observational study of Bariatric Surgery and Central Sensitization, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bariatric Surgery, Central Sensitization
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2018to 9 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are morbid obesity and had decided to undergo bariatric surgery
Who may be able to join
- Patients decided to undergo bariatric surgery
- Patients with knee pain more than 3 months.
Who cannot join
- Patients with mental impairment,
- Patients with inflammatory rheumatic disease,
- Patients who had previously undergone knee surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization
Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.
Read the detailed description
Weight loss in patients with knee OA reduces pain and provides functional improvement. It has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function.
Neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. It has been reported that neuropathic pain is more frequently seen in patients with high body mass index.
The hyperreactivity of the central nervous system (CNS) plays an important role in the chronic pain of OA patients. It has been shown that CNS becomes hypersensitive in people with chronic OA pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients.
The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.
- Conditions
- Bariatric Surgery, Central Sensitization
- Being tested
- Bariatric surgery
- Keywords
- bariatric surgery, central sensitization, knee pain, function, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery will done to the patients who were morbid obesity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1:patients who will undergo the bariatric surgery Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale (NRS)
It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).
Measured: 6 months
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
for function
Measured: 6 months
Nottingham Health Profile
for quality of life
Measured: 6 months
Central Sensitization Inventory (CSI)
for central sensitization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start9 Mar 2018 (estimated)
- Primary completion9 Dec 2018 (estimated)
- Study completion9 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Burcu Metin Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Burcu Metin Ökmen, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460691
- Sponsor's protocol ID
- 2011-KAEK-2017-19/20
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization
- ClinicalTrials.gov ID
- NCT03460691
- Acronym / sponsor ID
- 2011-KAEK-2017-19/20
- Conditions
- Bariatric Surgery, Central Sensitization
- Keywords
- bariatric surgery, central sensitization, knee pain, function, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 9 Mar 2018 (estimated)
- Primary completion
- 9 Dec 2018 (estimated)
- Study completion
- 9 Dec 2018 (estimated)
- First posted
- 9 Mar 2018 (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.
Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.
Detailed description
Weight loss in patients with knee OA reduces pain and provides functional improvement. It has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function.
Neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. It has been reported that neuropathic pain is more frequently seen in patients with high body mass index.
The hyperreactivity of the central nervous system (CNS) plays an important role in the chronic pain of OA patients. It has been shown that CNS becomes hypersensitive in people with chronic OA pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients.
The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Bariatric surgeryGroup 1:patients who will undergo the bariatric surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are morbid obesity and had decided to undergo bariatric surgery
Key inclusion criteria (2 listed)
- Patients decided to undergo bariatric surgery
- Patients with knee pain more than 3 months.
Key exclusion criteria (3 listed)
- Patients with mental impairment,
- Patients with inflammatory rheumatic disease,
- Patients who had previously undergone knee surgery
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 |
|---|---|---|
| Bariatric surgeryBariatric surgery will done to the patients who were morbid obesity | Procedure or surgery | Group 1 |
Primary outcome
numeric rating scale (NRS)
Time frame: 6 months
It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Time frame: 6 months
for function
Nottingham Health Profile
Time frame: 6 months
for quality of life
Central Sensitization Inventory (CSI)
Time frame: 6 months
for central sensitization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
Burcu Metin Ökmen principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Central Sensitization, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 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: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Burcu Metin Ökmen, M.D. (+902242955000, burcumetinokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (NRS) (time frame: 6 months). The study lists 4 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 9 Mar 2018.