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Genetic Variants Associated With Low Back Pain and Their Response to Treatment With Duloxetine or Propranolol

NCT03364075 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-08-28

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo controlled, three period crossover clinical trial. The main purpose of this study is to determine if Chronic Low Back Pain patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine or Propranolol, and if the effectiveness of treatment with these drugs can determined by the presence or absence of SNPs associated with the Serotonin receptor or Cathecol-O-MethylTransferase activity. Each treatment period will be of two weeks duration with a 1 week washout phase between treatment periods. Following a Latin square design, patients will be randomly assigned to one of six different treatment groups, starting their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating through the other treatments in the subsequent cycles. Effectiveness of treatment will be measured by means of Pain Index as the primary outcome measure, and secondary outcome measures will include Pressure Pain Threshold and the Pain Disability Index, Perceived Stress Scale, Symptom Checklist -90R and the Patient's Global Impression of Change questionnaires.

Conditions

  • Low Back Pain

Interventions

DRUG

Duloxetine

30 mg for seven days, then increased to 60 mg for seven days

DRUG

Propranolol

40 mg for seven days, then increase to 60 mg for seven days

GENETIC

Genotype for SNPs associated to Serotonin and COMT

DNA and RNA extraction from blood samples to identify genetic variants associated to pain pathways

DRUG

Placebo Treatment

1 capsule BID for two weeks

Sponsors & Collaborators

  • Mark Ware

    lead OTHER

Principal Investigators

  • Mark Ware, MBBS MRCP · Director of Clinical Research Alan Edwards Pain Management Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364075 on ClinicalTrials.gov