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Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity

Chronic Back Pain Clinical Trial

Official title:
Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity

Clinical Trial Summary

This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment (carbidopa/levodopa and celecoxib) for acute/subacute back pain. All eligible patients will be randomly assigned to 3 different group and receive a 12-week treatment of "carbidopa/levodopa+celecoxib ", of "placebo+celecoxib", and of "placebo+placebo". In addition, all participants will be MRI-scanned twice and assessed daily with a mobile app for pan, mood, and behavior.

Clinical Trial Description

This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment for acute/subacute back pain (carbidopa/levodopa and celecoxib).The dosage of carbidopa/levodopa is 25/100mg.After screening, all eligible patients will be randomly assigned to 3 different groups, with each receives a 12-week treatment of "carbidopa/levodopa+celecoxib (LDP+CLX)", of "placebo+celecoxib (PLC+CLX)", and of "placebo+placebo (PLC+PLC)". For each group, a subsequent 12-week follow-up efficacy evaluation will be conducted by telephone .At the end of the 24-week study, we will understand the durability of the treatment. During the drug treatment period for pain, all participants should return to the clinical follow-up center on week 0, 2, 6 and 12 to assess pain condition, properness of treatment and side effects .In the 24-week study of drug treatment and after treatment follow-up, pain and safety assessments will be conducted by telephone, at week 9, 16, and 20.In addition, all participants will be assessed daily with a mobile app for pain, mood and behavior.Participants will be scanned for brain structure images (T1), resting functional images (RS-fMRI) and diffusion tensor images (DTI) at the second follow-up visit (week 0) and at the end of study (week 24). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04082715
Study type Interventional
Source Second Affiliated Hospital of Wenzhou Medical University
Contact
Status Withdrawn
Phase Phase 2
Start date October 2019
Completion date December 2023
View Details
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