Melatonin for Post-Surgery Recovery in Teens with Scoliosis

(SurgerySMART Trial)

Overseen By Jennifer A Rabbitts, M.B.Ch.B.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Prescription insomnia medication

Disqualifiers: Cognitive impairment, Severe chronic condition, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 21 days

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Will I have to stop taking my current medications?

If you are taking over-the-counter supplements or other sleep aids, you will need to stop them for 1 week before starting the study medication. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is melatonin safe for humans?

The research does not provide specific safety data for melatonin in humans, but it has been used in animal studies without reported safety issues. ^{1 2 3 4 5}

How does melatonin differ from other treatments for scoliosis recovery?

Melatonin is unique because it is a natural hormone that may help improve bone quality and reduce scoliotic curvature, especially in those with melatonin deficiency. Unlike other treatments, it works by potentially restoring melatonin levels, which could prevent scoliosis development and improve bone density. ^{1 2 3 4 5}

What data supports the effectiveness of the drug melatonin for post-surgery recovery in teens with scoliosis?

Research suggests that low melatonin levels may be linked to the development of scoliosis, and studies in animals have shown that melatonin supplementation can prevent scoliosis after certain surgeries. This implies that melatonin might help in managing scoliosis-related conditions, although direct evidence for post-surgery recovery in teens is not provided. ^{1 2 4 5 6}

Who Is on the Research Team?

Jennifer A Rabbitts, M.B.Ch.B.

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 12-18 in California who are having spinal fusion surgery. They must have internet access and a smartphone, and their parents or guardians need to be involved. Teens with recent psychiatric admissions, very high BMI, untreated major medical conditions, or those on certain medications can't participate.

Inclusion Criteria

Can read and understand English

I am scheduled for spinal fusion surgery for a specific condition.

You are a resident of California.

Exclusion Criteria

I won't stop taking supplements or sleep aids for a week before starting the study medication.

I have a serious long-term health condition that needs regular treatment.

Psychiatric admission in prior 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants take melatonin or placebo and wear an actigraphy device before surgery

14 days

Daily check-ins (virtual)

Treatment

Participants continue taking melatonin or placebo and wear an actigraphy device after surgery

21 days

Daily check-ins (virtual)

Follow-up

Participants are monitored for sleep, pain, and quality of life outcomes

3 months

3 online surveys

What Are the Treatments Tested in This Trial?

Interventions

• Melatonin

Trial Overview The study is testing if melatonin syrup helps teens recover after spinal fusion surgery by improving sleep quality. It will check how well the treatment works and whether it's something patients are okay with using both short-term and long-term.

How Is the Trial Designed?

Group I: 3mg fast-dissolve pill (containing melatonin) Experimental Treatment 1 Intervention

Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.

Group II: 3mg fast-dissolve pill Placebo Group 1 Intervention

Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

A study comparing serum melatonin levels in seven adolescent girls with idiopathic scoliosis and seven matched controls found no significant differences in melatonin levels during the day or night.

These results suggest that melatonin levels in patients with established scoliosis do not differ from healthy individuals, indicating that melatonin may not play a role in the progression of scoliosis in mature patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin levels in idiopathic scoliosis. Diurnal and nocturnal serum melatonin levels in girls with adolescent idiopathic scoliosis. Bagnall, KM., Raso, VJ., Hill, DL., et al.[2019]

A study comparing melatonin production in 9 female adolescents with idiopathic scoliosis to 18 healthy controls found no significant differences in nighttime or daytime melatonin levels, suggesting melatonin deficiency is not a factor in human scoliosis.

Despite previous research indicating a potential link between melatonin and scoliosis in chickens, this study indicates that melatonin production does not play a role in the development of adolescent idiopathic scoliosis in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of melatonin in the pathogenesis of adolescent idiopathic scoliosis. Hilibrand, AS., Blakemore, LC., Loder, RT., et al.[2019]

A study involving 885 individuals, including 50 initial patients with adolescent idiopathic scoliosis (AIS), found no significant mutations in the melatonin-related receptors hMel-1B and RORalpha associated with AIS.

Although two genetic variants were identified in the GPR50 receptor, further analysis showed no significant association with AIS, suggesting that while melatonin may be related to scoliosis, the specific receptors studied do not appear to be involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of GPR50, hMel-1B, and ROR-alpha melatonin-related receptors and the etiology of adolescent idiopathic scoliosis. Shyy, W., Wang, K., Gurnett, CA., et al.[2021]

A case-control study measuring 24-hour urinary melatonin production in adolescents with idiopathic scoliosis found no significant differences in melatonin levels compared to age- and gender-matched controls, suggesting that melatonin deficiency is not a contributing factor to this condition.

The study included a comprehensive assessment of melatonin excretion over a full day and night cycle, and results indicated that both stable and severe cases of scoliosis did not show any association with melatonin deficiency, challenging previous assumptions about its role in scoliosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total 24-hour melatonin secretion in adolescent idiopathic scoliosis. A case-control study. Fagan, AB., Kennaway, DJ., Sutherland, AD.[2019]

The study involved 24 adolescents (15 with adolescent idiopathic scoliosis and 9 controls) and found that bone marrow stem cells (BMSCs) from both groups expressed similar mesenchymal cell markers, indicating normal characteristics.

Melatonin treatment did not significantly alter cAMP levels in BMSCs from adolescent idiopathic scoliosis patients compared to controls, suggesting that the melatonin signaling pathway may function normally in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A preliminary study of melatonin signaling transduction pathway in BMSCs from adolescent idiopathic scoliosis patients]. Wang, B., Li, HB., Qiu, Y., et al.[2018]

In a study involving 80 mice, melatonin treatment significantly reduced the incidence of scoliosis, with only 5% occurrence in bipedal mice receiving melatonin compared to 80% in untreated bipedal controls.

Melatonin treatment also improved bone quality and reduced the number of osteoclasts, suggesting that restoring melatonin levels can prevent scoliosis and enhance bone density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exogenous melatonin on reducing scoliotic curvature and improving bone quality in melatonin-deficient C57BL/6J mice. Liu, H., Liu, Z., Man, CW., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Melatonin levels in idiopathic scoliosis. Diurnal and nocturnal serum melatonin levels in girls with adolescent idiopathic scoliosis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The role of melatonin in the pathogenesis of adolescent idiopathic scoliosis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of GPR50, hMel-1B, and ROR-alpha melatonin-related receptors and the etiology of adolescent idiopathic scoliosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Total 24-hour melatonin secretion in adolescent idiopathic scoliosis. A case-control study. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[A preliminary study of melatonin signaling transduction pathway in BMSCs from adolescent idiopathic scoliosis patients]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The effect of exogenous melatonin on reducing scoliotic curvature and improving bone quality in melatonin-deficient C57BL/6J mice. [2021]