Ongoing Clinical Trials for Back Pain
Back pain affects millions of people worldwide, ranging from acute episodes to chronic conditions that persist for months or years. Currently, 15 clinical trials are investigating various treatments for back pain across Europe and beyond. These studies explore different therapeutic approaches, including antibiotics, pain medications, stem cell therapy, and innovative combinations of existing drugs. Trials are being conducted in multiple countries including Austria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, and Spain.
Clinical trial locations
- Austria
- Czechia
- Denmark
- France
- Germany
- Greece
- Study comparing diclofenac, orphenadrine and paracetamol combination versus diclofenac alone and orphenadrine-paracetamol combination in patients with acute low back pain
- Study Comparing Diclofenac and Thiocolchicoside Injection to Diclofenac Alone for Patients with Acute Moderate to Severe Low Back Pain
- Study on the Effectiveness of Diclofenac Sodium and Thiocolchicoside in Relieving Acute Low Back Pain in Adults
- Italy
- Study on Tricortin 1000, Diclofenac Sodium, and Paracetamol for Patients with Chronic Low Back Pain
- Study on the Effectiveness of Autologous Bone Marrow Mesenchymal Stem Cell Injection for Patients with Chronic Low Back Pain Due to Lumbar Disc Degeneration
- Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children
- Study on the Effectiveness and Safety of DFL24412 and Ketoprofen Lysine in Patients with Chronic Low Back Pain
- Study on the Effectiveness of Diclofenac Sodium and Thiocolchicoside in Relieving Acute Low Back Pain in Adults
- Netherlands
- Norway
- Poland
- Spain
- Study on the Use of Platelet Concentrate and Betamethasone for Treating Chronic Low Back Pain in Patients with Lumbar Disc Degeneration
- Study on the Effectiveness and Safety of DFL24412 and Ketoprofen Lysine in Patients with Chronic Low Back Pain
- Study on the Effects of VER-01, Ibuprofen, and Paracetamol for Patients with Chronic Non-Specific Low Back Pain
Study on Amoxicillin for Patients with Chronic Low Back Pain and Modic Type I Changes
This trial, conducted in the Netherlands, takes an innovative approach by testing whether an antibiotic can help with chronic pain. The study focuses on patients who have suffered from low back pain for more than six months and who also have specific spinal changes called Modic type I changes visible on MRI scans. These changes are associated with inflammation in the vertebrae next to a previously herniated disc.
Main inclusion criteria: Participants must be between 18 and 65 years old with chronic pain lasting over six months. They need to have had a disc herniation confirmed by MRI within the past six months to two years. The pain must be at least 5 out of 10 in intensity, and participants should answer yes to at least two questions about their symptoms, such as whether exercise increases pain or whether they experience morning pain.
Main exclusion criteria: People without chronic low back pain, those without Modic type I changes on MRI, individuals under 18, and vulnerable populations cannot participate.
Trial focus: The study investigates whether taking amoxicillin 500 mg tablets three times daily for three months can reduce pain and improve quality of life in this specific patient group. Participants will be randomly assigned to receive either amoxicillin or placebo in a double-blind design. Follow-up assessments, including another MRI scan, will be conducted at 12 months to evaluate changes in the spinal condition.
Investigational drug: Amoxicillin is being tested to determine if this common antibiotic can help patients with chronic low back pain and Modic type I changes by potentially addressing bacterial involvement in disc inflammation.
Study on Melatonin for Patients with Chronic Back Pain
This Danish trial explores the potential of melatonin, a hormone naturally produced in the body and commonly known for regulating sleep, as a treatment for chronic back pain. The study aims to determine whether taking melatonin can help reduce pain intensity in people who have been suffering for an extended period.
Main inclusion criteria: Participants must be between 18 and 64 years old with pain lasting at least three months. The pain should be present on most or every day during the past three months and should limit daily activities or work. Average pain intensity must be 4 or higher on a 0-10 scale in the past seven days. Women of childbearing potential must use effective contraception.
Main exclusion criteria: Those currently taking medications that might interfere with the study, individuals with allergies to melatonin, people with severe mental health disorders, patients with significant liver or kidney disease, pregnant or breastfeeding women, recent participants in other trials, and those with a history of substance abuse cannot join.
Trial focus: Participants will take 10 mg of melatonin in tablet form once daily before bedtime for six weeks. The study will compare the effects of melatonin with a placebo in a double-blind design. Pain levels will be assessed weekly using a scale from 0 to 10, with the main focus on average pain intensity over the past seven days.
Investigational drug: Melatonin is being studied for its potential to reduce chronic back pain, possibly through its antioxidant properties and effects on sleep quality and inflammation.
Study on Melatonin for Patients with Chronic Low Back Pain: A Randomized Trial
This trial in the Netherlands similarly investigates melatonin as a treatment for chronic low back pain. Like the Danish study, it examines whether this sleep-regulating hormone can provide meaningful pain relief.
Main inclusion criteria: Participants must be between 18 and 65 years old with chronic low back pain lasting at least three months. The pain must have been present on most days in the past three months and must have limited daily life or work activities. Average pain intensity must be at least 4 on a 0-10 scale in the past seven days.
Main exclusion criteria: Those not experiencing chronic low back pain, individuals under 18, people unable to take melatonin or with allergies to it, current participants in other trials, those with medical conditions deemed unsafe for participation, pregnant or breastfeeding women, people with substance abuse history, and those with mental health conditions that would interfere with participation are excluded.
Trial focus: The study will evaluate whether 10 mg of melatonin taken once daily before bedtime for six weeks can reduce pain intensity compared to placebo. Participants will be randomly assigned to treatment groups in a double-blind manner.
Investigational drug: Melatonin is being tested for its ability to reduce pain intensity through its hormone and antioxidant properties, which may help reduce inflammation and improve sleep patterns.
Study on the Use of Platelet Concentrate and Betamethasone for Treating Chronic Low Back Pain in Patients with Lumbar Disc Degeneration
This Spanish trial investigates a regenerative medicine approach using plasma rich in growth factors. The study compares this innovative treatment with conventional corticosteroid therapy for patients with disc degeneration in the lower spine.
Main inclusion criteria: Participants must be 18 years or older with lumbar disc degeneration confirmed by MRI showing more than level 1 on the Pfirrmann Scale. They must have positive signs at the L4-L5 and/or L5-S1 levels, including issues like rupture of the annulus fibrosus. Pain must have lasted at least three months without improvement from medication, with intensity between 6 and 10 on the COMI pain scale. A recent MRI within six months and complete blood tests within two months are required.
Main exclusion criteria: Those with recent lower back surgery, severe allergic reactions to medications, current participants in other trials, certain infections or immune system diseases, pregnant or breastfeeding women, history of drug or alcohol abuse, severe mental health conditions, certain heart conditions, recent lower back injury, or inability to follow study procedures are excluded.
Trial focus: The study compares PRGF-Endoret (plasma rich in growth factors) with Celestone Cronodose (a corticosteroid). Both treatments are administered through epidural injection. The trial will follow participants for 12 months, measuring pain relief and quality of life improvements using scales such as the Oswestry Scale, COMI scale, and SF-12 scale. MRI scans will also assess changes in disc degeneration.
Investigational drugs: PRGF-Endoret uses growth factors from the patient’s own blood to promote healing and tissue regeneration. Corticosteroids reduce inflammation and pain through their anti-inflammatory properties. Anesthetics provide immediate pain relief by blocking nerve signals.
Study on Tricortin 1000, Diclofenac Sodium, and Paracetamol for Patients with Chronic Low Back Pain
This Italian trial tests a combination approach for people experiencing sudden worsening of chronic pain. The study evaluates whether Tricortin 1000 injections can provide better relief than placebo and other standard treatments.
Main inclusion criteria: Participants must be 40-70 years old with chronic low back pain lasting at least three months but no more than six months, confirmed by CT or MRI. They must be experiencing a moderate to severe flare-up with pain between 4 and 8 on a 0-10 scale. Body Mass Index must be less than 30, and participants must be able to keep a diary and attend follow-up visits. They must not have used Tricortin 1000 previously and must stop certain pain medications before the study.
Main exclusion criteria: Those without chronic low back pain with acute worsening, people outside the specified age range, those from non-included vulnerable populations, and those not meeting the specific study criteria cannot participate.
Trial focus: The 15-day study involves daily intramuscular injections of Tricortin 1000, along with topical application of diclofenac sodium medicated plaster twice daily. Paracetamol is available as rescue medication. Participants will track their pain daily in a diary, with assessments conducted on Days 7 and 15 to measure pain relief and physical function improvements.
Investigational drug: Tricortin 1000 is being tested to determine its effectiveness in reducing pain during acute flare-ups of chronic low back pain, with the goal of improving quality of life.
Study comparing diclofenac, orphenadrine and paracetamol combination versus diclofenac alone and orphenadrine-paracetamol combination in patients with acute low back pain
This Greek trial examines whether combining three different pain medications in one tablet works better than existing two-drug combinations or single medications for acute pain episodes.
Main inclusion criteria: Participants must be 18-64 years old with acute low back pain starting within the last seven days. Pain intensity must be at least 75 on a visual pain scale (0-100). Participants must understand study requirements, agree to attend follow-up visits, and provide informed consent.
Main exclusion criteria: Those with severe allergic reactions to study medications or similar drugs, pregnant women or those planning pregnancy, breastfeeding mothers, active stomach or intestinal ulcers, significant kidney or liver problems, uncontrolled high blood pressure, recent heart attack or stroke, current use of blood-thinning medications, chronic pain lasting more than three months, previous back surgery, other conditions affecting back pain, current participation in other trials, substance abuse, alcohol dependency, mental health conditions interfering with pain assessment, or known allergies to study ingredients are excluded.
Trial focus: The five-day study compares a combination of diclofenac, orphenadrine, and paracetamol against Cataflam (diclofenac alone), Norgesic (orphenadrine and paracetamol), and placebo. All medications are taken orally. Pain intensity and back movement will be measured regularly to determine which treatment provides the best relief.
Investigational drugs: The three-medicine combination aims to provide comprehensive pain relief by combining anti-inflammatory effects, muscle relaxation, and pain reduction in a single tablet.
Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain
This trial, conducted in Austria and Germany, evaluates AP707 as an add-on treatment for people whose chronic pain persists despite current treatments. The study runs for 52 weeks to assess long-term effectiveness.
Main inclusion criteria: Participants must have chronic back pain lasting at least three months with a painDETECT score of 20 or more. They must be 18 years or older with current pain intensity greater than 5 on a 0-10 scale. Female participants and male participants with female partners must use reliable contraception. A good command of German is required to understand study questionnaires. Current pain treatment must be optimized and stable, and participants must have more than one year of life expectancy.
Main exclusion criteria: Those with other significant health conditions that might interfere with the study, current participants in other trials, recent surgery or planned surgery during the study, pregnant or breastfeeding women, history of substance abuse, inability to comply with procedures, known allergies to study medication, severe uncontrolled mental health disorders, cancer diagnosis in the past five years, or severe liver or kidney disease are excluded.
Trial focus: Participants will receive AP707 as a sublingual spray (applied under the tongue) or placebo for 52 weeks. Regular assessments will monitor changes in pain intensity using the Numerical Rating Scale and the Neuropathic Pain Symptom Inventory. The study also evaluates effects on psychological distress, quality of life, and sleep quality.
Investigational drug: AP707 is being studied to determine if it can provide additional pain relief when used alongside existing pain management strategies, potentially improving quality of life for chronic pain sufferers.
Study on the Effectiveness of Autologous Bone Marrow Mesenchymal Stem Cell Injection for Patients with Chronic Low Back Pain Due to Lumbar Disc Degeneration
This Italian trial represents a cutting-edge approach using regenerative medicine. The study tests whether stem cells taken from a patient’s own bone marrow can help repair damaged discs and reduce chronic pain.
Main inclusion criteria: Participants must be 18-65 years old with chronic low back pain due to moderate disc degeneration at no more than three levels, unresponsive to conservative treatments for at least six months. The outer layer of the spinal disc must be intact as shown by MRI. Pain level must be greater than 40 mm on a 0-100 Visual Analogue Scale. Participants must stop NSAIDs at least two days before screening and other painkillers at least 24 hours before. Women of childbearing potential must have a negative pregnancy test and use effective birth control for 24 months.
Main exclusion criteria: Those with conditions other than low back pain, more than three levels of lumbar disc degeneration, people outside the specified age range, and vulnerable populations are excluded.
Trial focus: The treatment involves a one-time injection of the patient’s own bone marrow mesenchymal stem cells directly into the affected intervertebral discs. Participants will be followed for 12 months with assessments at 1, 3, 6, and 12 months. Pain relief will be measured using the Visual Analogue Scale, functionality using the Oswestry Disability Index, and quality of life using the SF-36 questionnaire. MRI scans will assess changes in the treated discs.
Investigational drug: Autologous bone marrow mesenchymal stem cells are believed to promote tissue repair and regeneration by differentiating into various cell types and releasing growth factors that may help heal damaged discs.
Study on Zoledronic Acid for Patients with Chronic Low Back Pain with Modic Changes
This Norwegian trial investigates whether a medication typically used for bone conditions can help patients with specific spinal changes called Modic changes, which are associated with chronic pain.
Main inclusion criteria: Participants must have low back pain for more than 50% of days over the past six months, located below the 12th rib and above the buttocks. The Oswestry Disability Index score should be 30 or higher, and pain intensity should be 5 or higher on a 0-10 scale (average of current pain, worst pain in the last two weeks, and usual pain in the last two weeks). Participants must have Modic type 1 changes in the spine with specific size requirements. Age must be between 18 and 65 years.
Main exclusion criteria: Those not experiencing chronic low back pain with Modic changes, people outside the specified age range, vulnerable populations, and those not meeting other specific health criteria cannot participate.
Trial focus: Participants will receive two intravenous infusions of zoledronic acid 5 mg over the course of the study. The trial will monitor changes in back-specific disability using the Oswestry Disability Index and pain intensity using the Numerical Rating Scale over one year. Regular follow-up assessments will evaluate the effectiveness of the treatment.
Investigational drug: Zoledronic acid is a bisphosphonate that works by inhibiting bone resorption, which researchers believe may help alleviate pain and improve function in patients with Modic changes.
Study Comparing Diclofenac and Thiocolchicoside Injection to Diclofenac Alone for Patients with Acute Moderate to Severe Low Back Pain
This Greek trial evaluates whether combining a pain reliever with a muscle relaxant provides better relief than using the pain reliever alone for acute episodes of moderate to severe pain.
Main inclusion criteria: Participants must be 18 years or older with acute low back pain starting seven days or less before joining the study. Pain intensity must be moderate to severe, scoring 50 or more on a 0-100 visual scale. Participants must understand study requirements, agree to attend follow-up visits, and provide written consent voluntarily.
Main exclusion criteria: Those with allergies or bad reactions to thiocolchicoside and diclofenac, other serious health conditions, pregnant or breastfeeding women, current participants in other trials, history of drug or alcohol abuse, inability to understand or follow procedures, severe mental health conditions, certain heart conditions, or recent lower back injury are excluded.
Trial focus: The study compares intramuscular injections of a combination of diclofenac and thiocolchicoside with diclofenac alone. Pain relief will be measured at one hour and three hours after injection using a visual analogue scale. Secondary outcomes include the proportion of participants experiencing more than 30% pain reduction and changes in physical function measured by finger-to-floor distance.
Investigational drugs: Diclofenac provides pain relief and reduces inflammation, while thiocolchicoside acts as a muscle relaxant to relieve muscle spasms and stiffness. The combination aims to enhance overall pain relief and improve mobility.
Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children
This Italian trial focuses on pediatric acute pain, comparing two formulations of ibuprofen to determine which provides faster relief for children experiencing various types of pain including back pain from injuries.
Main inclusion criteria: Children must be 4-12 years old, admitted to the emergency room with acute pain as a main or additional symptom (such as sore throat, headache, ear pain, toothache, or injury-related pain). Pain level must be 4 or higher on an age-appropriate 1-10 scale. Parents or guardians must provide written informed consent, and children and adolescents must also provide their own consent. Children must be willing and able to follow study requirements.
Main exclusion criteria: Children outside the 2-12 age range, those with other serious health conditions, currently taking other medications that might affect results, allergies to ibuprofen or similar medications, history of stomach problems such as ulcers or bleeding, kidney or liver problems, asthma worsened by aspirin or other NSAIDs, or current participation in another trial are excluded.
Trial focus: The study compares lysin ibuprofen suspension with regular ibuprofen suspension administered orally. The primary assessment occurs five minutes after medication administration, with additional assessments at 10, 20, and 30 minutes. Pain levels will be measured using age-appropriate scales such as the Wong-Baker Faces Pain Scale and the Numerical Rating Scale. The study is single-blind, meaning participants do not know which medication they receive.
Investigational drugs: Lysin ibuprofen suspension is designed to be absorbed faster by the body, potentially leading to quicker pain relief compared to regular ibuprofen suspension.
Note: This article describes the first 10 trials in detail. Additional trials are being conducted in France, Italy, Spain, Greece, Poland, Czechia, and Germany, investigating various treatments including sodium chloride injections, combination pain medications, cannabis extracts, and different formulations of anti-inflammatory drugs. For complete information about all 15 ongoing trials, please visit the individual trial pages linked above.
Summary
The 15 ongoing clinical trials for back pain represent a diverse range of therapeutic approaches, from traditional pain medications to innovative regenerative therapies. A notable observation is the concentration of trials in Southern Europe, with Italy, Greece, and Spain hosting multiple studies. Germany and the Netherlands also contribute significantly to the research landscape.
Several trials focus on acute pain management using combinations of anti-inflammatory drugs and muscle relaxants, particularly diclofenac combined with other agents. These studies, primarily conducted in Greece and Italy, aim to determine optimal drug combinations for rapid pain relief.
An interesting trend is the investigation of non-traditional approaches. Multiple studies examine melatonin for chronic pain, exploring whether this sleep hormone can provide pain relief through its antioxidant and anti-inflammatory properties. The antibiotic amoxicillin is being tested based on theories about bacterial involvement in certain types of disc-related pain.
Regenerative medicine approaches feature prominently, including trials of platelet-rich plasma in Spain and autologous stem cell therapy in Italy. These studies represent cutting-edge research into whether the body’s own healing mechanisms can be harnessed to repair damaged spinal structures.
Several trials investigate medications typically used for other conditions, such as zoledronic acid (normally used for bone diseases) and cannabis extracts, reflecting the ongoing search for effective pain management alternatives to opioids.
The geographic distribution suggests strong research activity in Mediterranean countries, possibly reflecting different regulatory environments or research traditions. The variety of approaches being tested demonstrates that researchers are exploring multiple pathways to address this common and debilitating condition, from rapid-acting combinations for acute episodes to long-term regenerative solutions for chronic sufferers.
