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Beta Blocker

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
Central sensitization assessed via a standardized physiotherapy evaluation and the Central Sensitization Inventory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through data collection phase (estimated 6 months per population)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 been diagnosed with central sensitization.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
Pain neuroscience education (10 short videos - 2 to 4 mins each) 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
Pain neuroscience education (10 short videos - 2 to 4 mins each) 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
2018
N/A
~430
Propranolol Hydrochloride
2021
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
290 Previous Clinical Trials
68,897 Total Patients Enrolled
1 Trials studying Fibromyalgia
52 Patients Enrolled for Fibromyalgia
Guillaume Leonard, PhDPrincipal InvestigatorUniversité de Sherbrooke
2 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Propranolol Hydrochloride (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05085782 — Phase 2
Fibromyalgia Research Study Groups: Propranolol, Placebo
Fibromyalgia Clinical Trial 2023: Propranolol Hydrochloride Highlights & Side Effects. Trial Name: NCT05085782 — Phase 2
Propranolol Hydrochloride (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085782 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~8 spots leftby Sep 2024