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

Comparıson of the Effectıveness of Intramuscular Dıclofenac Sodıum and Subcutaneous 5% Dextrose Injectıon in Patıents Applyıng to the Emergency Department Wıth Low Back Paın.

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Drug: 5% dextrose prolotherapy; Drug: Diclofenac 75mg/ml

Detailed Description

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
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Aksaray, Turkey, 68000
    • Aksaray University Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: %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.	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; Other Names: Diclofenac 75mg/ml
Active Comparator: 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.	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).; Other Names: 5% dextrose prolotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Aksaray University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; emergency department; neuroprolotherapy; , diclofenac sodium,
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: AksarayUTRH-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The personal information of the participants in the study will be kept confidential and the data will be shared upon request.
• IPD Sharing Time Frame: 2 mount
• IPD Sharing Access Criteria: Personal information of the participants in the study will be kept confidential and will be provided by the principal investigator if the data is requested for scientific purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No