The Effect of Bariatric Surgery to Central Sensitization | NCT03460691

Studies
The Effect of Bariatric Surgery to Central Sensitization

NCT03460691

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Status

Unknown status

Last Update Posted

Mar 9, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Bariatric Surgery
Central Sensitization

Interventions

Bariatric surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2018Estimated

Primary Completion Date

Dec 9, 2018Estimated

Completion Date

Dec 9, 2018Estimated

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 8, 2018

First Posted Date

Mar 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2018

Last Update Posted Date

Mar 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Burcu Metin Ökmen, Principal Investigator, Bursa Yuksek Ihtisas Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bursa Yuksek Ihtisas Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Group 1:patients who will undergo the bariatric surgery	Procedure: Bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariatric surgery	Procedure	Bariatric surgery will done to the patients who were morbid obesity	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	6 months
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)	for function	6 months
Nottingham Health Profile	for quality of life	6 months
Central Sensitization Inventory (CSI)	for central sensitization	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are morbid obesity and had decided to undergo bariatric surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Burcu Metin Ökmen, M.D.	Contact	+902242955000		burcumetinokmen@gmail.com

Overall Officials

Name	Affiliation	Role
Burcu Metin Ökmen	Bursa Yuksek Ihtisas Training and Research Hospital	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

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