Oral melatonin effect on pain after percutaneous lumbar disc decompression: a double-blind randomized clinical trial
- Conditions
- Oral Melatonin effect on pain and disability after percutaneous disc decompression.
- Registration Number
- IRCT20220514054846N1
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
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)
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method