Efficacy of antibiotic treatment for patients with chronic low back pain and Modic type I changes - randomized placebo-controlled trial

Conditions

non-specific low back pain

Brief summary

Pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ)

Detailed description

LBP-intensity (0-10 NRS-scale), Leg pain intensity (0-10 NRS-scale), Global perceived effect (7-point Likert scale), Health-related quality of life (PROMIS-GH-10 and EQ-5D-5L), Self-reported number of days with sick leave, Co-interventions (pharmacological and non-pharmacological), Patients’ satisfaction with treatment (7-point Likert scale), Success of blinding (patient and physician), Compliance (pill count), Pain self-efficacy (Pain Self-Efficacy Questionnaire), Sleep (Pittsburgh Sleep Quality Index), Neuropathic pain (PainDETECT), MRI-imaging at 12 months follow-up (to investigate the outcome of the antibiotic treatment on the Modic changes), LBP-related health care costs measured with cost questionnaires (iMCQ and iPCQ)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAmoxicillin 500 mg film-coated tablets

DRUGPlacebo amoxicillin capsules 500mg

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ)	—

Secondary

Measure	Time frame
LBP-intensity (0-10 NRS-scale), Leg pain intensity (0-10 NRS-scale), Global perceived effect (7-point Likert scale), Health-related quality of life (PROMIS-GH-10 and EQ-5D-5L), Self-reported number of days with sick leave, Co-interventions (pharmacological and non-pharmacological), Patients’ satisfaction with treatment (7-point Likert scale), Success of blinding (patient and physician), Compliance (pill count), Pain self-efficacy (Pain Self-Efficacy Questionnaire), Sleep (Pittsburgh Sleep Quality Index), Neuropathic pain (PainDETECT), MRI-imaging at 12 months follow-up (to investigate the outcome of the antibiotic treatment on the Modic changes), LBP-related health care costs measured with cost questionnaires (iMCQ and iPCQ)	—

Measure

Time frame

LBP-intensity (0-10 NRS-scale), Leg pain intensity (0-10 NRS-scale), Global perceived effect (7-point Likert scale), Health-related quality of life (PROMIS-GH-10 and EQ-5D-5L), Self-reported number of days with sick leave, Co-interventions (pharmacological and non-pharmacological), Patients’ satisfaction with treatment (7-point Likert scale), Success of blinding (patient and physician), Compliance (pill count), Pain self-efficacy (Pain Self-Efficacy Questionnaire), Sleep (Pittsburgh Sleep Quality Index), Neuropathic pain (PainDETECT), MRI-imaging at 12 months follow-up (to investigate the outcome of the antibiotic treatment on the Modic changes), LBP-related health care costs measured with cost questionnaires (iMCQ and iPCQ)

—

Countries

Netherlands

Outcome results

None listed