Magnesium Oral Supplementation for Acute Non-specific Low Back Pain
The Effect of Magnesium Oral Supplementation for Acute Non-specific Low Back Pain: Prospective Randomized Clinical Trial
1 other identifier
interventional
240
1 country
1
Brief Summary
Acute non-specific low back pain (LBP) is one of the most common complaints at the emergency department. It is more prevalent in countries with high-income economies, where 60-80% of the population report back pain at some point in their life. Numerous medication options are available for acute LBP relief such as non-steroid anti-inflammatory drugs (NSAIDs), myorelaxant drugs, opioids, and benzodiazepines. Magnesium is a physiological voltage-dependent blocker of N-methyl-D-aspartate NMDA)-coupled channels that can influence inflammatory pain and neuropathic pain through several different mechanisms. In this study the investigators aimed to investigate the effect of magnesium oral supplementation for acute low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jun 2018
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2020
CompletedFirst Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedNovember 12, 2020
November 1, 2020
9 months
November 1, 2020
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Changed of Baseline Roland-Morris Disability Questionnaire score at 10 days
This scoring system is consist of a 24-item low back pain functional scale recommended for use in low back pain research. Its yes/no format is amenable to telephone follow-up. Higher scores signify greater low back-related functional impairment.
Baseline, at 4th and 10th days
Changed of Baseline VAS score at 10 days
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10).
Baseline, at 4th and 10th days
Secondary Outcomes (1)
Changed of Baseline Finger to floor test at 10 days
Baseline, at 4th and 10th days
Study Arms (3)
Isolated non-steroid anti-inflammatory drug group
ACTIVE COMPARATORA isolated NSAIDs group received 400 mg etodolac twice a day for 10 days in treatment of acute low back pain.
Non-steroid anti-inflammatory drug plus magnesium group
EXPERIMENTALThis group received 400 mg etodolac twice a day and 365 mg magnesium oral supplementation once a day for 10 days in treatment of acute low back pain.
Non-steroid anti-inflammatory drug plus paracetamol group.
ACTIVE COMPARATORThis group 400 mg etodolac twice a day and 500 mg paracetamol twice a day for 10 days in treatment of acute low back pain.
Interventions
Patients were treated with etodolac 400mg twice a day plus magnesium oral supplementation once a day for acute low back pain and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
Patients were treated with etodolac 400mg twice a day for acute low back pain and and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
Patients were treated with etodolac 400mg twice a day plus 500mg paracetamol twice a day paracetamol for acute low back pain and and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
Eligibility Criteria
You may qualify if:
- patients aged\>18 years old,
- initiation of acute low back pain in the 10 days prior to study entry and functionally impairing low back pain, which we defined as a score of \> 5 on the Roland-Morris Disability Questionnaire (RMDQ).
You may not qualify if:
- aged\>65 years old,
- history of trauma,
- radicular pain, which we defined as pain radiating below the gluteal folds,
- history of vertebral tumor or metastasis,
- patients who were pregnant or lactating,
- unavailable for follow-up,
- with allergy or contraindication to the investigational medications,
- chronic analgesic use,
- autoimmune diseases or inflammatory rheumatic disorders,
- cardiopulmonary restrictions,
- severe kidney or liver function disorders and prior surgery on the lumbar spine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University Istanbul Faculty of Medicine
Istanbul, Fatih, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Turgut Akgül, MD
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 12, 2020
Study Start
June 10, 2018
Primary Completion
March 15, 2019
Study Completion
March 8, 2020
Last Updated
November 12, 2020
Record last verified: 2020-11