Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Pain After TJA Clinical Trial

Official title:

Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03879707
• Other study ID #: 49586
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2020
• Est. completion date: June 2023

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Description:

Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain — poor-quality sleep — intensified pain — even poorer-quality sleep.

Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion criteria -Adults 18 years and older

Exclusion criteria -

1. No chronic pain

2. Patients underwent revision or bilateral surgery.

3. Patients underwent fracture.

4. Patients suffering from dementia / delirium

5. Patients on narcotics greater than 10mg hydrocodom before surgery

6. Not willing to participate

Related Conditions & MeSH terms

• Pain After TJA

Intervention

Drug:
• Melatonin 5 mg
Melatonin is known to induce sleep
• Placebo Oral Tablet
Placebo
• Magnesium 500Mg Oral Tablet
Magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, a neurotransmitter that promotes sleep. Research indicates supplemental magnesium can improve sleep quality, especially in people with poor sleep

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of melatonin and magnesium on pain	Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months.	90 days
Secondary	Effect of melatonin on daily activities	Effect of interventions daily activities using VAS pain scores. Higher the score. more difficulty in performing daily activities	90 days
Secondary	Effect of melatonin on daily activities	Effect of interventions on daily activities using Hip Disability and Osteoarthritis Outcome ( HOOS ) or Knee Disability and Osteoarthritis Outcome ( KOOS) score. The interval score ranges from 0 to 100 where 0 represents total hip/knee disability and 100 represents perfect hip/knee health	90 days
Secondary	Effect of melatonin on daily activities	Effect of intervention on daily activities using Western Ontario and McMaster Universities Arthritis Index (WOMAC). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	90 days
Secondary	Effect of melatonin on daily activities	Effect of intervention on daily activities using Pittsberg sleep quality index. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	90 days
Secondary	Effect of melatonin on daily activities	Effect of intervention on daily activities using SF 12 score. The lower the score the more disability	90 days