Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-03-31

Brief Summary

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The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.

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Detailed Description

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Conditions

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Sleep Disturbance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is a provider-crossover study design.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care

Study Groups

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Melatonin supplementation

5mg melatonin tablets to be taken for 6 weeks

Group Type ACTIVE_COMPARATOR

melatonin

Intervention Type DIETARY_SUPPLEMENT

Melatonin capsules to be taken for 6 weeks

No supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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melatonin

Melatonin capsules to be taken for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo primary ARCR
* Patient willing and able to complete postoperative surveys

Exclusion Criteria

* Daily melatonin use for \> 1 week during the last 3 months
* Irreparable tears
* Revision rotator cuff repairs
* Severe glenohumeral arthritis
* Concurrent adhesive capsulitis
* Age less than 18
* Pregnancy
* History of substance abuse (drug or alcohol)
* Workman's comp patient or patient has current litigation pending
* Allergy to melatonin
* History of delirium/psychiatric/depression/ on antidepressants
* History of insomnia/ on sleep aid medication
* Use of prescription sedatives
* use of Zelboraf (vemurafenib)
* Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
* Sleep apnea

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No