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

Aksaray University Training and Research Hospital

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Low Back Pain, Mechanical

Treatments: Drug: 5% dextrose prolotherapy; Drug: Diclofenac 75mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT06829030

AksarayUTRH-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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150 participants in 2 patient groups

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Experimental group

Description:

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.

Treatment:

Drug: 5% dextrose prolotherapy

intramuscular 75 mg diclofenac sodium injection

Active Comparator group

Description:

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.

Treatment:

Drug: Diclofenac 75mg/ml