Oral melatonin effect on pain after percutaneous lumbar disc decompression: a double-blind randomized clinical trial

Oral melatonin Effect on pain after percutaneous lumbar disc decompression

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220514054846N1

Enrollment

Registered

2024-02-26

Start date

2023-05-28

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Oral Melatonin effect on pain and disability after percutaneous disc decompression.

Interventions

Intervention 1: Intervention group: patients in trial group, will take 3 mg melatonin tablets in addition to drugs belong to control group. The drugs will register electronically and Medicines are pr

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Unilateral or bilateral chronic radicular low back pain. Moderate to high pain score (VAS 3 or higher). Confirmation of LDH in one to three lumbar levels based on MRI and physical examination findings. ASA class I-II. No respond to conservative treatments (at least for three months)

Exclusion criteria

Exclusion criteria: Include disc extrusion or sequestration. Disc height reduction of more than 50%. Severe spinal deformity. Tumor or spinal fracture or spondylolisthesis. Local or systemic infection. Use of anticoagulants. History of allergic reaction to study drugs. Pregnancy and breastfeeding. Severe disorders. Sudden onset of neurological deficit such as urinary and fecal incontinence. History of lumbar spine surgery. Peripheral neuropathy. Patient refusal.

Design outcomes

Primary

Measure	Time frame
Determining the effect of oral melatonin on patients pain relief after lumbar disc decompression by SLR physical examination degree in intervention and control groups that will done by pain fellowship in pain clinic in specific time. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Physical examination and determination SLR degree by pain fellowship in specific time.;Determining the effect of oral melatonin on patients pain relief by ( Oswestry Disability Index) using questionnaire that complete by pain fellowship. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Determination of McGill pain index using questionnaire that complete by pain fellowship.	—

Measure

Time frame

Determining the effect of oral melatonin on patients pain relief after lumbar disc decompression by SLR physical examination degree in intervention and control groups that will done by pain fellowship in pain clinic in specific time. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Physical examination and determination SLR degree by pain fellowship in specific time.;Determining the effect of oral melatonin on patients pain relief by ( Oswestry Disability Index) using questionnaire that complete by pain fellowship. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Determination of McGill pain index using questionnaire that complete by pain fellowship.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Fatemeh Morsal

Iran University of Medical Sciences

fatemehmorssali@yahoo.com+98 21 6435 2326

Outcome results

None listed

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