Clinical trial NCT06829030: Comparison of the Efficacy of Diclofenac Sodium and Subcutaneous 5% Dextrose Injection in Low Back Pain.
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Low Back Pain, Mechanical
Keywords: Low back pain
neuroprolotherapy
, diclofenac sodium,
emergency department
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Education and Research Hospital
Study officials:
References: