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Phospholipid From Cerebral Cortex.

A clinical trial is underway to assess the effectiveness of Tricortin 1000, a medication containing phospholipid from cerebral cortex and cyanocobalamin, in treating chronic low back pain. This double-blind, randomized study compares Tricortin 1000 with a placebo and an active control (diclofenac sodium medicated plaster) to determine its potential benefits for patients experiencing moderate to severe acute exacerbations of chronic low back pain.

Table of Contents

What is Tricortin 1000?

Tricortin 1000 is a medication being studied for the treatment of chronic low back pain. It contains two active ingredients: cyanocobalamin (a form of vitamin B12) and phospholipid from cerebral cortex (a substance derived from brain tissue)[1]. This medication is administered as an intramuscular injection, which means it’s injected directly into a muscle.

Purpose of the Study

Researchers are conducting a clinical trial to evaluate how effective Tricortin 1000 is in treating chronic low back pain. The main goal is to see if Tricortin 1000 works better than a placebo (a substance with no active ingredients) in reducing pain after 15 days of treatment[1]. They’re also comparing it to another pain treatment called diclofenac sodium, which is applied as a medicated plaster on the skin.

How Tricortin 1000 Works

While the exact mechanism isn’t fully explained in the study information, Tricortin 1000 is classified as a psychostimulant and nootropic drug[1]. This suggests it may work by:

  • Improving brain function and potentially affecting pain perception
  • Providing neuroprotective effects, which could help with nerve-related pain
  • Possibly reducing inflammation in the body
The combination of vitamin B12 and brain-derived phospholipids may offer unique benefits for treating chronic pain conditions.

Who Can Participate in the Study?

The study is looking for participants who meet specific criteria, including:

  • Adults aged 40-70 years old
  • Diagnosed with chronic mechanical low back pain lasting 3-6 months
  • Currently experiencing moderate to severe pain
  • Not previously treated with Tricortin 1000 for low back pain
  • Able to maintain a pain diary during the study
There are also several conditions that would prevent someone from participating, such as:
  • Pregnancy or breastfeeding
  • History of certain medical conditions (e.g., cancer, severe heart disease)
  • Recent physical therapy for low back pain
  • Allergies to the study medications
It’s important to note that these are just some of the criteria, and a healthcare professional would need to evaluate each potential participant thoroughly[1].

Study Design

The study is designed as a double-blind, randomized, controlled trial. This means:

  • Participants are randomly assigned to one of three groups:
    1. Tricortin 1000 injections
    2. Diclofenac sodium medicated plaster
    3. Placebo (inactive treatments)
  • Neither the participants nor the researchers know who is receiving which treatment during the study
  • The treatment period lasts for 15 days
  • Researchers will measure pain levels and other factors at the beginning, middle, and end of the study
This design helps ensure that the results are as unbiased and accurate as possible[1].

Potential Benefits

If Tricortin 1000 proves effective, it could offer several benefits for people with chronic low back pain:

  • Reduced pain intensity
  • Improved physical function and mobility
  • Better quality of life
  • A new treatment option for those who haven’t found relief with other medications
However, it’s important to remember that the study is still ongoing, and these potential benefits are not yet proven[1].

Safety Considerations

As with any medical treatment, safety is a crucial concern. The study will closely monitor participants for any side effects or adverse reactions. Some important safety points to note:

  • Tricortin 1000 is given as a daily intramuscular injection, which may cause some discomfort
  • Participants will undergo regular physical examinations and vital sign checks
  • The researchers will track any participants who withdraw from the study and why
  • People with certain medical conditions or allergies are not eligible to participate, to minimize potential risks
It’s crucial to remember that this is an investigational treatment, and its full safety profile is still being studied[1].

Aspect Details
Study Type Double-blind, randomized, placebo- and active-controlled clinical trial
Main Treatment Tricortin 1000 (containing phospholipid from cerebral cortex and cyanocobalamin)
Comparators Placebo and diclofenac sodium medicated plaster
Target Condition Chronic low back pain with acute exacerbation
Primary Outcome Change in pain relief from baseline to day 15
Secondary Outcomes Disability improvement, clinical improvement, patient and clinical global assessments, rescue medication use, safety
Treatment Duration 15 days
Key Inclusion Criteria Age 40-70, chronic mechanical low back pain for 3-6 months, moderate to severe acute exacerbation
Key Exclusion Criteria Non-specific low back pain, history of spine surgery, severe degenerative processes, contraindications to study medications

FAQ

  • What is the main goal of this clinical trial? The main goal is to show that Tricortin 1000 is better than a placebo in reducing pain for patients with chronic low back pain and acute flare-ups after 15 days of treatment.
  • Who can participate in this study? Participants must be between 40 and 70 years old, have chronic mechanical low back pain for 3-6 months, and experience a moderate to severe acute flare-up at the start of the study. They must also meet other specific criteria, such as having a BMI under 30 kg/m2 and not having used Tricortin 1000 before for low back pain.
  • How is Tricortin 1000 administered in this trial? Tricortin 1000 is given as an intramuscular injection. Patients receive a daily dose of 2 ml for 15 days.
  • What are the other treatment groups in this study? Besides the Tricortin 1000 group, there is a group receiving diclofenac sodium medicated plaster (applied to the skin) and a placebo group. The study uses a double-blind, double-dummy design to ensure fair comparison.
  • How will the effectiveness of Tricortin 1000 be measured? The main measure of effectiveness is the change in pain levels from the start of treatment to day 15, using a numerical rating scale. Other measures include improvements in disability, range of motion, clinical assessments, and the need for additional pain relief medication.

Ongoing Clinical Trials on Phospholipid From Cerebral Cortex.

  • Study on Tricortin 1000, Diclofenac Sodium, and Paracetamol for Patients with Chronic Low Back Pain

    Recruiting

    3 1 1
    Investigated drugs:
    Italy

Glossary

  • Chronic low back pain: Pain in the lower back that persists for 3 months or longer.
  • Acute exacerbation: A sudden worsening or flare-up of symptoms in a chronic condition.
  • Double-blind study: A research design where neither the participants nor the researchers know who is receiving which treatment, to prevent bias.
  • Placebo: An inactive substance or treatment used as a control in a medical study.
  • Intramuscular injection: A method of administering medication by inserting a needle directly into a muscle.
  • Body Mass Index (BMI): A measure that uses your height and weight to work out if your weight is healthy.
  • NRS-11: Numerical Rating Scale, a tool used to measure pain intensity on a scale from 0 to 10.
  • Oswestry Low Back Pain Disability Index (ODI): A questionnaire used to measure the degree of disability and quality of life in a person with low back pain.
  • Range of Motion testing: An assessment of how much a joint can move in different directions.
  • Patient Global Assessment (PGA): A measure where patients rate their overall health or condition.

References

  1. http://clinicaltrials.eu/trial/study-on-tricortin-1000-diclofenac-sodium-and-paracetamol-for-patients-with-chronic-low-back-pain/