Study Comparing Diclofenac and Thiocolchicoside Injection to Diclofenac Alone for Patients with Acute Moderate to Severe Low Back Pain

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What is this study about?

This clinical trial is focused on studying the treatment of acute moderate to severe low back pain. The study will compare the effectiveness and tolerability of two different treatments. One treatment is a combination of two medications, Diclofenac and Thiocolchicoside, which are given as an injection. The other treatment is an injection of Diclofenac alone, commonly known as Voltaren. Both treatments are administered through an injection into the muscle.

The purpose of the study is to determine if the combination of Diclofenac and Thiocolchicoside provides better pain relief than Diclofenac alone in patients experiencing acute low back pain. Participants in the study will receive one of the two treatments and will be monitored to assess how well their pain is managed. The study will measure pain relief using a simple scale where patients rate their pain level.

Participants will be involved in the study for a short period, with the main focus being on the change in pain levels a few hours after receiving the treatment. The study aims to provide valuable information on which treatment option might be more effective for managing acute low back pain. Some participants may receive a placebo, which is a treatment with no active medication, to help compare the effects of the actual medications being tested.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and experiencing acute low back pain for 7 days or less with moderate to severe intensity.

Consent is required to participate, ensuring understanding of the study requirements and agreement to attend follow-up visits.

2 initial assessment

An initial assessment is conducted to evaluate the level of pain using a visual analogue scale (VAS), which ranges from 0 to 100.

This assessment helps establish a baseline for measuring changes in pain levels during the trial.

3 medication administration

Participants receive an injection of either a combination of diclofenac sodium and thiocolchicoside or diclofenac sodium alone.

The medication is administered intramuscularly, meaning it is injected into a muscle.

4 monitoring and follow-up

Pain levels are monitored at intervals, specifically 1 hour and 3 hours after the medication is administered.

The primary goal is to observe the change in pain levels from the baseline to 3 hours post-administration.

5 evaluation of results

The effectiveness of the medication is evaluated based on the reduction in pain intensity, with a focus on achieving a significant decrease in pain levels.

Secondary outcomes include the proportion of participants experiencing a reduction in pain intensity by more than 30% and changes in physical function, such as the finger-to-floor distance.

6 completion of the trial

The trial concludes with a final assessment of pain relief and any side effects experienced during the study.

Participants’ experiences and outcomes contribute to understanding the effectiveness and tolerability of the medications tested.

Who Can Join the Study?

Must be 18 years old or older.
Currently experiencing acute low back pain that started 7 days ago or less and is of moderate to severe intensity. This means the pain is quite strong, scoring 50 or more on a visual scale from 0 to 100, where 0 is no pain and 100 is the worst pain imaginable.
Must be able to understand what the clinical trial involves and agree to come back for follow-up visits. If needed, this also applies to a legally authorized representative who can make decisions on behalf of the patient.
Willing to give written consent voluntarily before any procedures related to the clinical trial are done. This also applies to a legally authorized representative if necessary.

Who Cannot Join the Study?

Patients who have allergies or bad reactions to the study medications, which include Thiocolchicoside and Diclofenac.
Patients with other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are currently participating in another clinical trial, as this could affect the results of the study.
Patients who have a history of drug or alcohol abuse, which might interfere with their ability to follow the study instructions.
Patients who are unable to understand or follow the study procedures, which is important for their safety and the accuracy of the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kat Attica General Hospital	Kifissia	Greece

Other Sites

Site Name	City	Country	Status
Peiraiko Therapeftirio S.A.	Piraeus	Greece
Gyjxtuc Heyvuwia ow Tevee	Thiva	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.07.2024

Trial locations

Investigated drugs:

Diclofenac: This medication is used to relieve pain and reduce inflammation. It is commonly used for conditions such as arthritis, muscle pain, and back pain. In this trial, Diclofenac is being used as a reference product to compare its effectiveness against a combination product.

Thiocolchicoside: This is a muscle relaxant that helps to relieve muscle spasms and stiffness. It is often used in combination with other medications to enhance pain relief and improve mobility in patients with muscle-related pain.

Combination IM product of Diclofenac and Thiocolchicoside: This is a new product being tested in the trial. It combines the pain-relieving and anti-inflammatory effects of Diclofenac with the muscle-relaxing properties of Thiocolchicoside. The goal is to determine if this combination is more effective in relieving acute moderate to severe low back pain compared to Diclofenac alone.

Acute Moderate to Severe Low Back Pain – This condition involves sudden onset pain in the lower back region, which can range from moderate to severe intensity. It often results from muscle strain, ligament sprain, or other mechanical issues affecting the spine. The pain may be sharp or dull and can limit movement, making daily activities challenging. It typically develops quickly, often after physical activity or an awkward movement. The pain may radiate to the buttocks or legs, depending on the underlying cause. Over time, the intensity of the pain may fluctuate, but it generally requires management to improve mobility and comfort.

Trial ID:

2024-512786-13-00

Protocol code:

DITH/VER

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Diclofenac and Thiocolchicoside Injection to Diclofenac Alone for Patients with Acute Moderate to Severe Low Back Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?