"Antibiotic treatment in patients with chronic low back pain and bone edema on MRI adjacent to a previously herniated disc or adjacent to a degenerated disc: a double-blind study where patients at random are offered antibiotics or placebo tablets without knowing which tablets they are given."

• Register: EUCTR
• Last refreshed on: 7 June 2021
• Main ID: EUCTR2013-004505-14-NO
• Date of registration: 31/08/2016
• Prospective Registration: No
• Primary sponsor: Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser
• Public title: "Antibiotic treatment in patients with chronic low back pain and bone edema on MRI adjacent to a previously herniated disc or adjacent to a degenerated disc: a double-blind study where patients at random are offered antibiotics or placebo tablets without knowing which tablets they are given."
• Scientific title: Antibiotic treatment in patients with chronic low back pain and Modic Changes: a double-blind randomized placebo-controlled trial
• Date of first enrolment: 04/03/2015
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004505-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Norway

Contacts

• Name: Kjersti Storheim
• Affiliation: Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser

• Name: Kjersti Storheim
• Affiliation: Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria will be as follows:
•Age between 18 and 65 years
•LBP of > 6 months duration in the area from L1 to L5 with a Numerical Rating Scale (NRS) score of ? 5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks).
•MRI-confirmed disc herniation within the preceding 2 years or degenerated disc (Pfirrmann grade ? 348) at level L3/L4, L4/L5 or L5/S1.
•MC type I or type II adjacent to a previously herniated disc or adjacent to a degenerated disc (Pfirrmann grade ? 348), based on T1- and T2 weighted MRI.
•Both conservative and surgically treated patients will be included.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria:
•Allergy to antibiotics or gradolinium contrast
•Current pregnancy or lactation
•Any kidney disease or pending litigation
•Any specific LBP diagnosis that may explain patients symptoms.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

A recent Danish study published during spring 2013 advances a remarkable cause and treatment with Amoxicillin for a selected sub-group of low back pain patients.The study was based upon a hypothesis that chronic low back pain may arise from a low-grade infection of the intervertebral disc by the anaerobic Proprione acne bacteria, resulting in pain and bone edema (Modic changes). The main scope of this RCT is to re-examine the effect of amoxicillin in this patient group.

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Amoxicillin 750mg
ATC-nr.: J01C A04
Product Name: Amoxicillin
Product Code: ATC-nr.: J01C A04
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Change in RMQ wil be evaluated at 1-year follow-up.

Primary end point(s): The primary outcome measures in the clinical part of the study will be pain and disability measured by the Norwegian version of the disease-specific Roland and Morris Questionnaire (RMQ)24;50. The RMQ ranges from 0 to 24, with lower score indicating less severe pain and disability. A clinically important change will be defined as a 30 % reduction of the individual’s baseline score.

Main Objective: To re-examine the finding that antibiotic treatment can cure patients with chronic low back pain, earlier disc herniation, and Modic changes.
We will evaluate the effect of antibiotic treatment versus placebo on pain and disability, bothersomeness, health-related quality of life, sick leave, patients’ satisfaction and side effects from inclusion to 1-year follow-up. Our trial will be the first to re-examine the Danish Modic-antibiotica study.

Secondary Objective: To compare change in Modic changes on MRI from inclusion to 1-year follow-up between treatment groups, and to assess whether characteristics of Modic changes by different MRI methods are related to the clinical effects of antibiotic treatment.
Further, to contribute to a clarification of the pathogenesis of Modic changes by studying gene expression of inflammatory biomarkers, and to conduct health economic analysis.

Secondary Outcome(s)

Secondary end point(s): Secondary outcomes will be lumbar pain and leg pain, hours with pain during the last 4 weeks, bothersomeness, health-related quality of life (EuroQoL-5D), days with sick leave, patient’s satisfaction, and functional capacity (Oswestry Disability Index).

Timepoint(s) of evaluation of this end point: Data will be collected at baseline during follow-up, and at 1-year follow-up. Secondary outcomes will be evaluated at 1 year follow-up.

Secondary ID(s)

Modic02

Source(s) of Monetary Support

A. Oslo universitetssykehus HF, Ullevål sykehus, FORMI-Formidlingsenheten for muskel- og skjelettlidelser. B. Helse Vest

Ethics review

Status: Approved
Approval date: 04/03/2015
Contact: