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Enrolling by Invitation

NCT Number: NCT06829030

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

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aksaray University Education and Research Hospital

Aksaray, 68000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Other names: Diclofenac 75mg/ml

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).

Other names: 5% dextrose prolotherapy

Primary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Aksaray University Training and Research Hospital

Other

Registry information

Official study 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.

Acronym: NPT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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