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Clinical Trials/NCT03460691
NCT03460691
Unknown
Not Applicable

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

Bursa Yüksek İhtisas Education and Research Hospital0 sites50 target enrollmentMarch 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Enrollment
50
Primary Endpoint
numeric rating scale (NRS)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2018
End Date
December 9, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Burcu Metin Ökmen

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

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

Outcomes

Primary Outcomes

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).

Nottingham Health Profile

Time Frame: 6 months

for quality of life

Central Sensitization Inventory (CSI)

Time Frame: 6 months

for central sensitization

Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

Time Frame: 6 months

for function

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