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Study on the Effectiveness of Diclofenac Sodium and Thiocolchicoside in Relieving Acute Low Back Pain in Adults

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for low back pain, a common and often disabling condition that affects many people. The study will test a combination of two medications: diclofenac sodium and thiocolchicoside, which are given as a solution for injection. Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) that helps reduce pain and inflammation, while thiocolchicoside is a muscle relaxant that helps relieve muscle stiffness. The study will compare this combination treatment to diclofenac sodium alone and a placebo to see which is more effective in relieving back pain symptoms.

The purpose of the study is to determine if the combination of diclofenac sodium and thiocolchicoside is better at reducing pain than diclofenac sodium alone or a placebo. Participants in the study will receive injections of the medications over a short period. The study will monitor changes in pain levels and muscle stiffness over several days to assess the effectiveness of the treatments. Participants will be asked to rate their pain using a simple scale, and the study will track how their pain changes over time.

Throughout the study, the safety of the treatments will be closely monitored by checking for any side effects or changes in health. The study aims to provide valuable information on how well these treatments work for people with acute moderate to severe low back pain, helping to improve pain management strategies for this common condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and the presence of acute low back pain.

A written informed consent is required to participate in the study.

2 initial treatment phase

The treatment begins with an intramuscular injection of a fixed combination of diclofenac 75 mg and thiocolchicoside 4 mg.

This injection is administered twice, once on Day 1 and once on Day 2.

3 pain assessment

Pain levels are assessed using a 100-mm Visual Analog Scale (VAS) to measure the intensity of pain.

Assessments occur at four intervals: two in the morning and two in the evening, up to Day 3.

4 secondary assessments

Additional assessments include changes in muscle contracture and disability due to low back pain, measured on Day 3 and Day 7.

The Schober index is used to evaluate muscle contracture.

5 rescue medication

If necessary, diclofenac 50 mg tablets may be used as rescue medication.

The use of rescue medication is monitored, including the number of tablets used and the duration of use, up to Day 7.

6 safety monitoring

Safety is monitored through the frequency of adverse events and any discontinuation of treatment due to these events.

Changes in laboratory parameters, electrocardiogram (ECG) results, and vital signs are also tracked.

7 completion of study

The study is expected to conclude by March 31, 2025.

Final assessments and data collection occur at the end of the study period.

Who Can Join the Study?

  • Male and female patients who are 18 years or older.
  • Patients experiencing acute low back pain (LBP) at the start of treatment. This pain is located below the shoulder blades and above the buttocks, and must have started no more than 12 weeks before the screening visit.
  • Back pain must be of moderate to severe intensity, which means it measures 50 mm or more on a pain scale called the Visual Analogic Scale (VAS).
  • Patients must have a stable muscle contracture, which is a condition where the muscle is tight. This is checked by a test called the Schober test, where the increase in distance between two points on the back is less than 5 cm.
  • If female and able to have children, the patient must use a highly effective method of birth control. This includes methods like hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
  • If female and able to have children, the patient must not be nursing and should not become pregnant during the study. A negative pregnancy test is required before starting the study.
  • Patients must be in satisfactory general health, as determined by the study doctor based on medical history and a physical exam.
  • Patients must understand and provide written informed consent before participating in the study. They need to understand the study procedures and be willing to complete the required assessments.

Who Cannot Join the Study?

  • Patients who have allergies or bad reactions to the study medications.
  • Individuals with serious health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • People who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Individuals who cannot follow the study procedures or instructions.
  • People with certain medical conditions that the study doctor thinks might affect the results.
  • Patients who are taking medications that might interfere with the study treatment.
  • Individuals with a history of severe allergic reactions.
  • People with infections or other conditions that require immediate treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Saint Savvas Oncology Hospital Athens Greece
Universita’ Campus Bio-medico Di Roma Rome Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Turin Italy
Afjnzyt Ovjuotfmola Utuotlybuictq Pntbo Parma Italy
Avq Dhenshbbmkhmmrnjfue Varese Italy
Ajqbabi Sebxbdnfg Lzomvf do Pkasfeq Potenza Italy
Ahfksdj Oehngnceztp Uhruockmbrthu Scuold Siena Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not recruiting
22.05.2023
Italy Italy
Not recruiting
22.05.2023

Trial locations

Investigated drugs:

Diclofenac is a medication used to relieve pain and reduce inflammation. In this clinical trial, it is administered as a solution for injection. The study aims to evaluate its effectiveness in alleviating symptoms of acute moderate to severe low back pain.

Thiocolchicoside is a muscle relaxant that helps reduce muscle stiffness and spasms. In this trial, it is combined with diclofenac in a fixed-dose solution for injection. The combination is being tested to see if it provides superior pain relief compared to diclofenac alone in patients with low back pain.

Low Back Pain – Low back pain is a common and often disabling condition affecting the lower portion of the spine. It can be acute or chronic, with most adults experiencing it at least once in their lifetime. The pain may originate from the intervertebral discs, muscles, or joints in the back. It typically results in discomfort and limited mobility, impacting daily activities. The condition can vary in intensity, ranging from mild discomfort to severe pain. Understanding the underlying cause is crucial for managing symptoms and improving function.

Trial ID:
2024-518753-42-00
Protocol code:
EPDICTIO75+4F01-2022
Trial Phase:
Therapeutic confirmatory (Phase III)

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