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

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

Status
Enrolling by invitation
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06829030
Acronym
NPT
Enrollment
150
Registered
2025-02-17
Start date
2024-07-15
Completion date
2025-02-28
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Mechanical

Keywords

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

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).

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.

Interventions

DRUG5% 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

DRUGDiclofenac 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).

Sponsors

Aksaray University Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
VASIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026