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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

6 criteria

  • 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.
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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.

What is already known about the treatment

  • Diclofenac

    Diclofenac is administered as an intramuscular injection and is widely used in medicine for its anti-inflammatory and pain-relieving properties. It is commonly prescribed for conditions like acute moderate to severe low back pain. Diclofenac works by inhibiting the enzymes that produce prostaglandins, which are chemicals in the body responsible for inflammation and pain. It belongs to the pharmacological class of nonsteroidal anti-inflammatory drugs (NSAIDs).

  • Thiocolchicoside

    Thiocolchicoside is also administered via intramuscular injection and is used in combination with other medications to treat muscle spasms associated with acute moderate to severe low back pain. It acts as a muscle relaxant by binding to specific receptors in the central nervous system, helping to reduce muscle stiffness and discomfort. Thiocolchicoside is classified as a muscle relaxant and is often used in combination therapies to enhance pain relief.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512786-13-00Protocol codeDITH/VEREstimated enrolment140 patientsSponsorVerisfield Single Member S.A.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).