Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

Обзор

The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change." The main questions the trial aims to answer are: * What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? * What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain. Participants in the trial will: * Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study. * Take either amoxicillin or a placebo daily for 100 days. * Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics. * Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests. * Complete questionnaires at baseline, 3 months, 6 months, and 12 months.

Вмешательства

• Препарат Amoxicillin
  Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days
• Другое Placebo
  Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days

Первичные конечные точки

• Roland Morris Disability Questionnaire (RMDQ) [Срок оценки: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.]

Вторичные конечные точки (12)

• LBP-intensity (0-10 NRS-scale) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Leg pain intensity (0-10 NRS-scale) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Health-related quality of life (PROMIS-GH-10) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Self-reported number of days with sick leave [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Co-interventions (pharmacological and non-pharmacological) [Срок оценки: Measured at baseline, 3 months and 12 months]
• Global perceived effect (7-point Likert scale) [Срок оценки: Measured at 3 months, 6 months and 12 months]
• Patients' satisfaction with treatment (7-point Likert scale) [Срок оценки: Measured at baseline, 3 months and 12 months]
• Success of blinding [Срок оценки: Measured at 3 months and 12 months]
• Compliance [Срок оценки: Measured at 3 months]
• Pain self-efficacy (Pain Self-Efficacy Questionnaire) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]
• Sleep questionnaire (Pittsburgh Sleep Quality Index) [Срок оценки: Measured at baseline, 3 months, 6 months and 12 months]

Критерии участия

Критерии включения

• Aged 18-65 years.
• Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
• At least 2 of the following questions should be answered with "Yes":

• Does training and/or exercise increase your pain?
• Is your sleep during the night disturbed due to your back pain?
• Is it painful to turn over in bed at night?
• Do you suffer from morning pain?
• The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
• Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.

Критерии исключения

• Received antibiotic treatment in the past month.
• Current pregnancy, lactation or pregnancy-wish.
• Severe physical or psychiatric co-morbidities.
• LBP resulting from a specific cause such as a tumor or fracture.
• Surgery or epidural injection in the past 6 months.
• Previous antibiotic course of 100 days.
• Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU)
• Contra-indication for MRI.
• Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
• Hepatic or renal (eGFR≤30) impairment.
• Inability to swallow capsules.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Публикации

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. PMID 30496104
• Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available. PMID 35507483
• Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13. PMID 23404353
• Braten LCH, Rolfsen MP, Espeland A, Wigemyr M, Assmus J, Froholdt A, Haugen AJ, Marchand GH, Kristoffersen PM, Lutro O, Randen S, Wilhelmsen M, Winsvold BS, Kadar TI, Holmgard TE, Vigeland MD, Vetti N, Nygaard OP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grovle L, Brox JI, Zwart JA, Storheim K; AIM study group. Efficacy of antibiotic treatment in patients with chronic low back p PMID 31619437
• Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3. PMID 29971708
• Agamennone V, Krul CAM, Rijkers G, Kort R. A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands. BMC Gastroenterol. 2018 Aug 6;18(1):103. doi: 10.1186/s12876-018-0831-x. PMID 30078376
• Jafarnejad S, Shab-Bidar S, Speakman JR, Parastui K, Daneshi-Maskooni M, Djafarian K. Probiotics Reduce the Risk of Antibiotic-Associated Diarrhea in Adults (18-64 Years) but Not the Elderly (>65 Years): A Meta-Analysis. Nutr Clin Pract. 2016 Aug;31(4):502-13. doi: 10.1177/0884533616639399. Epub 2016 Apr 29. PMID 27130655

Идентификаторы

NCT: NCT06771492 · 2024-515824-35 · 2024-515824-35-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗