The Effect of Bariatric Surgery to Central Sensitization

Bariatric Surgery Clinical Trial

Official title:

Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03460691
• Other study ID #: 2011-KAEK-2017-19/20
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2018
• Last updated: March 8, 2018
• Start date: March 9, 2018
• Est. completion date: December 9, 2018

Study information

• Verified date: March 2018
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Burcu Metin Ökmen, M.D.
• Phone: +902242955000
• Email: burcumetinokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 9, 2018
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Central Sensitization

Intervention

Procedure:
• Bariatric surgery
Bariatric surgery will done to the patients who were morbid obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

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