Comparison of the Efficacy of Diclofenac Sodium and Subcutaneous 5% Dextrose Injection in Low Back Pain.
NCT ID: NCT06829030
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2024-07-15
2025-02-28
Brief Summary
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Detailed Description
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The study is planned to include 150 volunteer patients with low back pain who applied to the emergency department of Aksaray University Education and Research Hospital. The patients will be randomly divided into two groups. The first group will receive subcutaneous 5% dextroseprolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection (approximately 75 patients). In all patients, pain intensity will be measured and recorded using the VAS immediately before the injection (baseline), 30 minutes, 1 hour, 2 hours, 12 hours and 24 hours after the injection, and evaluations will be made.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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%5 dekstroz proloterapi
The study is planned to include 75 volunteer patients with low back pain who presented to the emergency department of Aksaray University Education and Research Hospital. The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection.
5% dextrose prolotherapy
The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection
intramuscular 75 mg diclofenac sodium injection
The study is planned to include 75 volunteer patients with low back pain who presented to the emergency department of Aksaray University Education and Research Hospital. The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection.
Diclofenac 75mg/ml
The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection (approximately 75 patients).
Interventions
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5% dextrose prolotherapy
The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection
Diclofenac 75mg/ml
The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection (approximately 75 patients).
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* intolerance to NSAIDs or allergy to Diclofenac sodium,
* history of gastrointestinal bleeding,
* pregnancy
* patients with red flags for BP (trauma history, recent lumbar surgery, stenosis, spondylolisthesis, lumbar spondylosis with myelopathy)
* documented symptoms as red flags (new leg/foot weakness, new loss of -balance or walking ability, new fever, new night sweats, new urinary retention, new loss of bowel/bladder control)
* known cancer
* long-term steroid use
* patients requiring rescue treatment during the study
18 Years
55 Years
ALL
No
Sponsors
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Aksaray University Training and Research Hospital
OTHER
Responsible Party
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huseyin mutlu
Ass.Prof.
Locations
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Aksaray University Education and Research Hospital
Aksaray, , Turkey (Türkiye)
Countries
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Other Identifiers
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AksarayUTRH-1
Identifier Type: -
Identifier Source: org_study_id
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