Comparison of the Efficacy of Diclofenac Sodium and Subcutaneous 5% Dextrose Injection in Low Back Pain.

Phase 2Enrolling By InvitationNCT06829030

Aksaray University Training and Research Hospital150 enrolled

Overview

The aim was to compare the effectiveness of intramuscular diclofenac sodium and subcutaneous 5% dextrose injection in patients presenting to the emergency department with low back pain using the visual analog scale (VAS). 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Low Back Pain, Mechanical

Interventions

5% dextrose prolotherapyDRUG

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/mlDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

* Applying to emergency clinics * Having isolated low back pain * Being between the ages of 18-55 Exclusion Criteria: * Patients under 18 and over 55 years of age, * 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

Locations (1)

Aksaray University Education and Research Hospital

Aksaray, Turkey (Türkiye)

Outcomes

Primary Outcomes

VAS

It was measured using the Visual Analog Scale (VAS). A score of zero indicated no pain and a score of ten indicated severe, unbearable pain. 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.

Time frame: 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.

Data from ClinicalTrials.gov

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