The Effect of Bariatric Surgery to Central Sensitization

March 8, 2018 updated by: Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: 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

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Burcu Metin Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 9, 2018

Primary Completion (Anticipated)

December 9, 2018

Study Completion (Anticipated)

December 9, 2018

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-KAEK-2017-19/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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