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Study on Tricortin 1000, Diclofenac Sodium, and Paracetamol for Patients with Chronic 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 effectiveness of a treatment called Tricortin 1000 for people experiencing chronic low back pain. Chronic low back pain is a long-lasting discomfort in the lower back area, which can sometimes become more intense. The study aims to see if Tricortin 1000 can provide better pain relief compared to a placebo, which is a substance with no active medication. Participants in the study will receive either Tricortin 1000, a placebo, or other treatments like ITAMI 140 mg medicated plaster containing diclofenac sodium, or ACETAMOL adulti 500 mg tablets containing paracetamol.

The study will last for a period of 15 days, during which participants will be monitored for changes in their pain levels. The treatment involves using Tricortin 1000 as an injection into the muscle, while the other treatments are applied topically or taken orally. Participants will be asked to keep a diary to track their pain and any other symptoms they experience. The study will also assess the safety of the treatments by checking participants' health through physical exams and monitoring any side effects.

Throughout the study, participants will have regular visits to evaluate their progress. These visits will include tests to measure their range of motion and other physical responses. The goal is to determine if Tricortin 1000 can significantly improve pain relief and overall function in people with chronic low back pain compared to other treatments and a placebo. The study is designed to provide valuable information on the potential benefits of Tricortin 1000 for managing chronic low back pain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and baseline assessment
Upon joining the study, the first step involves an initial visit where a baseline assessment is conducted. This includes confirming the diagnosis of chronic low back pain through a CT or MRI scan if not already available from the past nine months.
During this visit, eligibility criteria are reviewed, including age, medical history, and current health status. A negative pregnancy test is required for female participants, along with the use of effective contraception if applicable.
Step 2
Medication administration
Participants will receive daily Tricortin 1000 injections, administered intramuscularly. This medication is intended to help relieve pain associated with chronic low back pain.
In addition, a diclofenac sodium medicated plaster will be applied twice daily to the affected area. This topical treatment is designed to provide additional pain relief.
Step 3
Use of rescue medication
Participants are allowed to use paracetamol as a rescue medication for additional pain relief if needed. The dosage and frequency will be monitored and recorded throughout the study.
Step 4
Follow-up visits and assessments
Follow-up visits are scheduled on Day 7 and Day 15 of the study. During these visits, various assessments will be conducted to evaluate the effectiveness of the treatment.
These assessments include measuring changes in pain levels, evaluating physical function, and monitoring any side effects or adverse events. Participants will also complete a diary to track their daily experiences and medication use.
Step 5
Completion of the study
At the end of the 15-day period, participants will undergo a final evaluation to assess the overall impact of the treatment on their chronic low back pain.
The study aims to determine the effectiveness of Tricortin 1000 compared to a placebo in providing pain relief and improving quality of life for individuals with chronic low back pain.

Who can join the trial?

11 criteria

Have a clinical diagnosis of chronic low back pain for at least 3 months but no more than 6 months, confirmed by a CT or MRI scan within the last 9 months. If not available, a new MRI should be done between the first and second study visits.
If female, must have a negative urine pregnancy test and use a highly effective form of birth control for at least one month before the study and during the study. Alternatively, females must be surgically sterile or postmenopausal for at least one year. Effective birth control methods include hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
Must not have used Tricortin 1000 in the past for low back pain or other conditions.
Have a moderate to severe sudden worsening of chronic low back pain at the start of the study, with a pain score between 4 and 8 on a scale from 0 to 10.
Be between 40 and 70 years old.
Be able to keep a diary during the study.
Have a Body Mass Index (BMI) of less than 30 kg/m². BMI is a measure of body fat based on height and weight.
Stop using any pain relief medications, except for paracetamol, and not plan to restart them during the study. This includes stopping NSAIDs, opioids, corticosteroids, muscle relaxants, and other treatments that might affect the study.
Must not have taken antidepressants or benzodiazepines for at least 60 days before the study.
Be able to read and understand the study materials, attend follow-up visits, and comply with study requirements.
Must have completed the informed consent process and signed the consent form.

Who cannot join the trial?

4 criteria

Patients who do not have chronic low back pain with an acute exacerbation (a sudden worsening of symptoms) at the start of the study.
Patients who are not within the specified age range for the study.
Patients who belong to a group that is not included in the study.
Patients who are part of a vulnerable population that is not selected for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

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Investigated drugs

Tricortin 1000 is a medication being tested in this clinical trial to see if it can help people with chronic low back pain feel better. The goal is to find out if it can reduce pain more effectively than a placebo, which is a substance with no active ingredients. The trial will measure how much pain relief Tricortin 1000 provides over a period of 15 days. Participants in the trial will have their pain levels checked before and after taking the medication to see if there is any improvement.

What is already known about the treatment

Tricortin 1000 – Tricortin 1000 is administered in a form that is suitable for treating chronic low back pain, although the specific method of application is not detailed in the trial data. Currently, it is being evaluated in clinical trials to determine its effectiveness compared to a placebo in providing pain relief for patients with chronic low back pain. The main therapeutic indication for Tricortin 1000 is to alleviate pain associated with chronic low back pain, especially during acute flare-ups. While the exact molecular mechanism of action is not specified, it is being studied for its potential to improve pain relief. Tricortin 1000 falls under the pharmacological classification of pain management medications.

Investigated diseases

Low Back Pain – Low back pain is a common condition characterized by discomfort in the lower back area. It can be caused by various factors, including muscle strain, ligament sprain, or issues with the spine such as herniated discs. The pain may be acute, lasting a few days to weeks, or chronic, persisting for more than three months. It often starts suddenly after an injury or gradually due to wear and tear over time. The pain can range from a dull ache to a sharp, stabbing sensation and may be accompanied by stiffness or reduced range of motion. In some cases, it can radiate to the legs, affecting mobility and daily activities.