Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

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

Study Overview

• Status: Withdrawn
• Conditions: Pain After TJA
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Melatonin 5 mg; Drug: Magnesium 500Mg Oral Tablet

Detailed 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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Melatonin and magnesium for 14 days	Drug: Melatonin 5 mg; Melatonin is known to induce sleep; Drug: 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
Placebo Comparator: Control; Placebo for 14 days	Drug: Placebo Oral Tablet; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Derek Amanatullah, M.D. PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: 49586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No