Enrolling by invitation NCT06829030

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

Phase I / Phase II Interventional Low Back Pain, Mechanical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 5% dextrose prolotherapy, Diclofenac 75mg/ml.
Who it may be relevant to: Registry conditions: Low Back Pain, Mechanical. Basic parameters: 18 years — 55 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparıson Of The Effectıveness Of Intramuscular Dıclofenac Sodıum And Subcutaneous 5% Dextrose Injectıon In Patıents Applyıng To The Emergency Department Wıth Low Back Paın.

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).

Detailed description

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.

Interventions

Drug 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
Drug 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).

Primary outcome measures

VAS [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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Single blind
Primary purpose: Treatment

Study locations

Turkey (Türkiye) · 1 center

Aksaray University Education and Research Hospital — Aksaray

Identifiers

NCT: NCT06829030 · AksarayUTRH-1

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗