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

NCT06829030 | Enrolling By Invitation Phase 1

• 1 other identifier: AksarayUTRH-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Low Back Pain, Mechanical

Keywords

Low back pain; neuroprolotherapy; , diclofenac sodium,; emergency department

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

%5 dekstroz proloterapi

EXPERIMENTAL

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

intramuscular 75 mg diclofenac sodium injection

ACTIVE COMPARATOR

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

Interventions

5% dextrose prolotherapy DRUG

The first group will receive subcutaneous 5% dextrose prolotherapy (approximately 75 patients), and the second group will receive intramuscular 75 mg diclofenac sodium injection

Also known as: Diclofenac 75mg/ml

%5 dekstroz proloterapi

Diclofenac 75mg/ml DRUG

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).

Also known as: 5% dextrose prolotherapy

intramuscular 75 mg diclofenac sodium injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray University Education and Research Hospital

Aksaray, 68000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Emergencies

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Model Details: Patients will be randomly divided into two groups. The first group will receive subcutaneous 5% dextroseprolotherapy, and the second group will receive intramuscular 75 mg diclofenac sodium injection.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: July 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 28, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 mount
• 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.

Locations

TU (1)