- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460691
The Effect of Bariatric Surgery to Central Sensitization
Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Burcu Metin Ökmen, M.D.
- Phone Number: +902242955000
- Email: burcumetinokmen@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients decided to undergo bariatric surgery
- Patients with knee pain more than 3 months.
Exclusion Criteria:
- Patients with mental impairment,
- Patients with inflammatory rheumatic disease,
- Patients who had previously undergone knee surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Group 1:patients who will undergo the bariatric surgery
|
Bariatric surgery will done to the patients who were morbid obesity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Time Frame: 6 months
|
for function
|
6 months
|
Nottingham Health Profile
Time Frame: 6 months
|
for quality of life
|
6 months
|
Central Sensitization Inventory (CSI)
Time Frame: 6 months
|
for central sensitization
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burcu Metin Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2011-KAEK-2017-19/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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