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The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain

The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back pain

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20111109008035N4
Enrollment
48
Registered
2017-12-29
Start date
2017-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain. Dorsalgia, unspecified

Interventions

Intervention 1: Melatonin or N-acetyl-5-methoxy tryptamine 3 milligrams per night for one month (during 20 physiotherapy sessions on alternate days). Intervention 2: Zolpidem or Ambien 5 milligrams pe
Treatment - Drugs
Melatonin or N-acetyl-5-methoxy tryptamine 3 milligrams per night for one month (during 20 physiotherapy sessions on alternate days)
Zolpidem or Ambien 5 milligrams per day for one month (during 20 physiotherapy sessions on alternate days)

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with non-specific low back pain who complain of insomnia and poor quality of sleep for more than 1 month.

Exclusion criteria

Exclusion criteria: Herniated lumbar discopathy; malignancy; sleep apnea; psychosis; drug abuse; past history of other sleep disorders and medical problems affecting sleep quality such as diabetes mellitus & chronic renal failure.

Design outcomes

Primary

MeasureTime frame
Sleep quality. Timepoint: At the start and end of the study. Method of measurement: Pittsburgh questionnaire and Actigraphy.

Secondary

MeasureTime frame
Visual Analogue Scale. Timepoint: At the start and end of the study. Method of measurement: Visual Analogue Scale.;Disability. Timepoint: At the start and end of the study. Method of measurement: With Oswestry disability index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadBagher Shamsi

Kermanshah University of Medical Sciences

mbshamsi@yahoo.com+98 83 3724 1929

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026