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Study comparing diclofenac, orphenadrine and paracetamol combination versus diclofenac alone and orphenadrine-paracetamol combination in patients with acute low back pain

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What is this study about?

This study examines the effectiveness of different treatments for acute low back pain. The main treatment being tested is a combination of three medicines: diclofenac, orphenadrine, and paracetamol in a single tablet. This combination will be compared to two other treatments: Cataflam (which contains only diclofenac) and Norgesic (which contains orphenadrine and paracetamol), as well as placebo.

The purpose of the study is to determine if the three-medicine combination works better than the other treatments for reducing severe back pain. During the study, participants will take their assigned medication for 5 days. Some participants will receive the new combination treatment, while others will receive either Cataflam, Norgesic, or placebo.

The study will use tablets that look similar to ensure that neither the participants nor the healthcare providers know which treatment is being given. All medications will be taken by mouth. The study will measure how well each treatment reduces pain intensity and improves back movement. Throughout the study, participants will be monitored for any side effects that may occur from the medications.

1 Initial visit and pain assessment

Your back pain intensity will be measured using a special scale called Visual Analog Scale (VAS)

A physical test measuring your ability to bend forward (Finger-to-Floor Distance test) will be performed

You will be randomly assigned to receive one of the following treatments: a combination of three medicines, single medicine, or placebo

2 Treatment period begins

You will receive one of these treatments:

– A combination tablet containing diclofenac, orphenadrine, and paracetamol

– Cataflam tablets (containing diclofenac)

– Norgesic tablets (containing orphenadrine and paracetamol)

– Placebo tablets (containing no active medicine)

All medicines will be taken by mouth

Additional pain relief medicine will be available if needed

3 First follow-up visit

Your pain level will be measured again using the same scale

The Finger-to-Floor Distance test will be repeated

Any side effects will be recorded

The amount of additional pain relief medicine used will be checked

4 Final visit

Final measurement of your pain level

Final Finger-to-Floor Distance test

Review of any side effects experienced during the study

Final count of additional pain relief medicine used

Assessment of whether your pain has become mild

Who Can Join the Study?

  • Must be between 18 and 64 years old
  • Must have acute low back pain that started within the last 7 days with severe intensity (pain level of at least 75 on a visual pain scale where patients mark their pain level on a line from 0 to 100)
  • Must be able to understand what is required during the clinical trial and agree to attend all follow-up visits
  • Must be willing to sign a voluntary informed consent form (a document stating you understand and agree to participate in the trial) before any trial procedures begin
  • Can be either male or female

Who Cannot Join the Study?

  • History of severe allergic reactions to any of the study medications or similar drugs (NSAIDs – pain and inflammation reducing medications)
  • Pregnant women or those planning pregnancy during the study period
  • Breastfeeding mothers
  • Active stomach or intestinal ulcers
  • Significant kidney or liver problems
  • Uncontrolled high blood pressure
  • History of heart attack or stroke in the past 6 months
  • Current use of blood-thinning medications
  • Chronic back pain lasting more than 3 months
  • Previous back surgery
  • Other conditions that could affect back pain (such as nerve problems, tumors, or infections)
  • Current participation in other clinical trials
  • Substance abuse or alcohol dependency
  • Mental health conditions that could interfere with pain assessment
  • Known allergies to any ingredients in the study medications

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

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

Trial status

Country Status Recruitment Start
Greece Greece
Recruiting
02.02.2026

Trial locations

Investigated drugs:

Diclofenac
A pain-relieving and anti-inflammatory medication commonly used to treat acute pain conditions. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that help reduce pain, swelling, and inflammation.

Orphenadrine
A muscle relaxant medication that helps relieve muscle pain and stiffness. It works by blocking nerve impulses that cause muscle spasms and pain.

Paracetamol
A pain reliever and fever reducer that works by affecting certain parts of the brain that receive pain signals. It’s one of the most commonly used pain medications worldwide, also known as acetaminophen in some countries.

Diclofenac + Orphenadrine + Paracetamol
A combination medication that combines the pain-relieving and anti-inflammatory effects of diclofenac, the muscle-relaxing properties of orphenadrine, and the pain-relieving effects of paracetamol. This combination is designed to provide more comprehensive relief for severe low back pain.

Norgesic
A combination medication containing orphenadrine and paracetamol, used to treat muscle pain and stiffness. It combines the muscle-relaxing effects of orphenadrine with the pain-relieving properties of paracetamol.

Cataflam
A brand name for diclofenac, used to relieve pain and reduce inflammation in various conditions, including low back pain.

Low Back Pain – A condition characterized by pain and discomfort in the lower portion of the back, typically between the bottom of the ribcage and the top of the legs. The pain can range from mild to severe and may be accompanied by muscle tension, stiffness, and limited mobility in the lower back region. It can develop suddenly (acute) or gradually (chronic) and may be caused by various factors including muscle strain, ligament sprain, poor posture, or physical activity. The condition can affect daily activities and movement patterns, often making it difficult to bend, twist, or maintain certain positions. People with low back pain may experience reduced flexibility and may find it challenging to perform tasks that involve the lower back.

Trial ID:
2025-521578-32-00
Protocol code:
DI-OR-PA
Trial Phase:
Therapeutic confirmatory (Phase III)

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