The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain

Ali Gur

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Dexketoprofen (KETAVEL 50 mg/2 ml); Combination Product: Methylprednisolone (Corticosteroid)

Study type: Interventional

Funder types: Other

Identifiers

NCT06932367

TTU-2021-9373 (Other Grant/Funding Number)

B.30.2.ATA0.01.00/286

Details and patient eligibility

About

Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged over 18 and under 65 years.
• The patients who presented to the emergency department with acute non-traumatic low back pain.
• Voluntarily agreed to participate in the study.

Exclusion criteria

• The patients who had used analgesics within the last six hours;
• Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
• Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
• Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
• The patients who were illiterate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Group 1 was the patients who was receiving intravenous dexketoprofen treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48

Treatment:

Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)

Group 2

Active Comparator group

Description:

Group 2 was the patients who was receiving intravenous dexketoprofen combined with methylprednisolone treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48.

Treatment:

Combination Product: Methylprednisolone (Corticosteroid)