Pain After TJAEarly Phase 1NCT03879707
Improving Sleep Quality After Total Joint Arthroplasty ( TJA)
A Early Phase 1 study testing Melatonin 5 mg and Magnesium 500Mg Oral Tablet in people with Pain After TJA, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is the evaluate and improve sleep quality after Total joint replacement. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain After TJA
- What is being tested?
- Melatonin 5 mg and Magnesium 500Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Jun 2028
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- No chronic pain
- Patients underwent revision or bilateral surgery.
- Patients underwent fracture.
- Patients suffering from dementia / delirium
- Patients on narcotics greater than 10mg hydrocodom before surgery
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.
Read the 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.
- Conditions
- Pain After TJA
- Being tested
- Melatonin 5 mg, Placebo Oral Tablet, Magnesium 500Mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 mgDrug
Melatonin is known to induce sleep
Placebo Oral TabletDrug
Placebo
Magnesium 500Mg Oral TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Melatonin and magnesium for 14 days Receives: Drug: Melatonin 5 mg; Drug: Magnesium 500Mg Oral Tablet |
| Control | Placebo comparator | Placebo for 14 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (5)
Effect of melatonin on daily activities
Effect of interventions daily activities using VAS pain scores. Higher the score. more difficulty in performing daily activities
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startJun 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: Investigator elected not to proceed with project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After TJAStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Amanatullah, Stanford University
- Investigators
- Derek Amanatullah, M.D. PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879707
- Sponsor's protocol ID
- 49586
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2019
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep Quality After Total Joint Arthroplasty ( TJA)
- ClinicalTrials.gov ID
- NCT03879707
- Acronym / sponsor ID
- 49586
- Conditions
- Pain After TJA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator elected not to proceed with project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Melatonin 5 mg, Drug: Magnesium 500Mg Oral TabletMelatonin and magnesium for 14 days |
| Control | Placebo comparator | Drug: Placebo Oral TabletPlacebo for 14 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- No chronic pain
- Patients underwent revision or bilateral surgery.
- Patients underwent fracture.
- Patients suffering from dementia / delirium
- Patients on narcotics greater than 10mg hydrocodom before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 5 mgMelatonin is known to induce sleep | Drug | Experimental |
| Placebo Oral TabletPlacebo | Drug | Control |
| Magnesium 500Mg Oral TabletMagnesium 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 | Drug | Experimental |
Primary outcome
Effect of melatonin and magnesium on pain
Time frame: 90 days
Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months.
5 secondary outcomes
Effect of melatonin on daily activities
Time frame: 90 days
Effect of melatonin on daily activities
Time frame: 90 days
Effect of melatonin on daily activities
Time frame: 90 days
Effect of melatonin on daily activities
Time frame: 90 days
Effect of melatonin on daily activities
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Amanatullah, M.D. PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin 5 mg and Magnesium 500Mg Oral Tablet in people with Pain After TJA, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of melatonin and magnesium on pain (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.