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Propranolol Reconsolidation Therapy for Chronic Pain

Phase 2

Recruiting

Led By Guillaume Leonard, PhD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be French speaking

Suffering from chronic low back pain or fibromyalgia for more than 6 months

Must not have

Medication with which co-administration of propranolol is contra-indicated

Litigation surrounding the painful condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through data collection phase (estimated 6 months per population)

Summary

This trial looks at using pain neuroscience education and reconsolidation therapy with propranolol to treat adults suffering from chronic pain. Its aim is to see if it is effective in reducing pain and improving function.

Who is the study for?

This trial is for French-speaking adults who have been experiencing chronic low back pain or fibromyalgia with an average pain level of at least 4 out of 10 for more than six months. Participants should show signs of central sensitization. Those with severe neurological/psychiatric conditions, health issues that conflict with propranolol use, recent lower-back surgery, or involved in litigation due to their pain cannot join.

What is being tested?

The study tests the combination of pain neuroscience education and reconsolidation therapy using Propranolol Hydrochloride against a placebo to see if it's feasible and acceptable for treating chronic pain. The impact on patients' pain and function will be measured one month after treatment.

What are the potential side effects?

Propranolol may cause dizziness, fatigue, trouble sleeping, or upset stomach. It can also affect heart rate and blood pressure. Since this is a test involving education and therapy as well, there might be no side effects from those parts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak French.

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I have had chronic low back pain or fibromyalgia for over 6 months.

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My average pain level is 4 or higher on a scale of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medication that cannot be combined with propranolol.

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I am involved in a lawsuit related to my pain condition.

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I cannot take propranolol due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through data collection phase (estimated 6 months per population)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through data collection phase (estimated 6 months per population)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through data collection phase (estimated 6 months per population) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability outcome 1 : perceived burden of the intervention (prospective and retrospective)

Acceptability outcome 2 : perceived ethicality of the intervention (prospective and retrospective)

Acceptability outcome 3 : perceived coherence of the intervention (prospective and retrospective)

+6 more

Secondary study objectives

Change in Central sensitization

Change in Emotional functioning

Change in Pain intensity

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PropranololExperimental Treatment3 Interventions

1. Pain neuroscience education (10 short videos - 2 to 4 mins each) 2. 6 weekly sessions of Reconsolidation therapy with propranolol. At the beginning of each session, participants will take 2 to 4 capsules of 20 mg propranolol (dose calculated based on sex and height). One hour after ingestion of the propranolol, participants will undergo a reactivation procedure, wherein they will be asked to describe/visualize painful movements/activities.

Group II: PlaceboPlacebo Group3 Interventions

1. Pain neuroscience education (10 short videos - 2 to 4 mins each) 2. 6 weekly sessions of Reconsolidation therapy with a placebo. At the beginning of each session, participants will take 2 to 4 capsules of 20 mg placebo (dose calculated based on sex and height). One hour after ingestion of the placebo, participants will undergo a reactivation procedure, wherein they will be asked to describe/visualize painful movements/activities.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pain neuroscience education

2023

N/A

~560

Propranolol Hydrochloride

2021

Completed Phase 3

~130