Could a lactic acid shot ease your back pain?
NCT ID NCT04673461
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an injection called STA363, made from lactic acid, for people with long-term low back pain from damaged spinal discs. About 110 adults who had not gotten relief from other treatments received either a low dose, a high dose, or a placebo injection into their painful discs. The main goal was to see if the treatment reduced pain over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lactic acid (STA363)
- What this could lead to
- If it works, this could offer a new injection-based treatment for chronic low back pain caused by damaged discs, potentially reducing pain without surgery.
- What could go wrong
- This is an early Phase 2 trial with only 110 people, so results may not apply to everyone. The treatment is still experimental, and its long-term safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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110 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Oct 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent prior to any study related procedures. 2. Male and female patients ≥18 and ≤70 years. 3. Chronic discogenic low back pain present for more than 6 months prior to the screening visit. 4. Insufficient response or lack of response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medications \[paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids\], physiotherapy, rehabilitation therapy etc.). 5. Patients who meet all the following NRS selection criteria: 1. Presence of ≥5 pain NRS assessments (entries) for 7 consecutive days. 2. NRS daily pain scores between 3-9. 3. Not more than two ratings "3". 6. One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1 as confirmed by a central reader, AND the following criteria are met: 1. Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is considered eligible only if IVD of grade 3 will be injected). 2. Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1. 3. Not more than two IVDs of grade 3 at any lumbar level. 4. No IVDs of grade 4 or 5 at any lumbar level. 7. Ability to understand the written and verbal information about the study. Exclusion Criteria: 1. Treatment with any investigational product within 3 months prior to the screening visit. 2. Patients with more than two painful IVDs. 3. A painful IVD above L2/3 level. 4. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection. 5. Previous lumbar spine surgery. 6. Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation). 7. Evidence of prior lumbar vertebral body fracture or trauma. 8. Need for spinal decompression assessed by the Investigator. 9. Presence of IVD extrusion or sequestration, or other radiologic findings that in the opinion of the investigator disqualify the patient from being included. 10. Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s). 11. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD. 12. Patients previously included in the study. 13. Patients suffering from psychosomatic pain in the opinion of the Investigator. 14. Leg pain of compressive origin. 15. Patients requiring continuous treatment with warfarin or other anticoagulant therapy. 16. History of significant neurologic or psychiatric disorders including dementia or seizures. 17. Known alcohol and/or drug abuse. 18. Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study. 19. Pregnant or lactating females, or intention to become pregnant within the study period. 20. Known allergy to any of the components of the drug product or placebo. 21. Known allergy or intolerance to the contrast agent Omnipaque®. 22. Known opioid allergy or intolerance. 23. Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study. 24. Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alrijne Ziekenhuis Leiderdorp
Leiderdorp, Netherlands
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Bekhterev Psychiatry and Neurology Center
Saint Petersburg, Russia
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Belgorod Regional Clinical Hospital of Saint Joasaph
Belgorod, Russia
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Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain
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Hm Puerta Del Sur
Móstoles, Spain
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Hospital Quirónsalud Córdoba
Córdoba, Spain
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Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Spain
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Kirov State Medical University
Kirov, Russia
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Krasnoyarsk Interdistrict Clinical Emergency Hospital
Krasnoyarsk, Russia
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LLC MART
Saint Petersburg, Russia
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Ochapovsky Regional Clinical Hospital #1
Krasnodar, Russia
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Privolzhsky Research Medical University
Nizhny Novgorod, Russia
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Regional Clinical Hospital #3
Chelyabinsk, Russia
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Rijnstate Hospital Anesthesiology and Pain
Velp, Netherlands
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Siberian Research Clinical Center
Krasnoyarsk, Russia
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Smolensk Regional Clinical Hospital
Smolensk, Russia
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Tula Regional Clinical Hospital
Tula, Russia
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