Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain
NCT ID: NCT05085782
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2022-02-07
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary aim of the study is to estimate the effect size of the intervention on pain and function one month post-intervention, and to obtain data for sample-size calculation for a subsequent randomized controlled trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
NCT04950426
Propranolol for Treating Fibromyalgia Pain
NCT03029845
Nondrug Treatment Programs for Adults With Fibromyalgia
NCT00088777
Pain Management Techniques for Fibromyalgia
NCT00086060
A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
NCT00965601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objectives: The primary objective of this study will be to document the feasibility and acceptability of a combined pain neuroscience education and reconsolidation blockade intervention with oral propranolol (or placebo) in adult patients with chronic pain (specifically, low back pain or fibromyalgia). The secondary objective will be to estimate the effect size of the intervention on function and pain one month post-intervention, and to obtain the data necessary for a sample size calculation of a subsequent larger scale study.
Description: The research design is a quantitative, placebo-controlled clinical trial (Phase II) feasibility study. The sample will consist of French-speaking adults with chronic low back pain or fibromyalgia (n=24 per population; 12 control and 12 experimental participants for each population; allocation by minimization); participants with a contraindication to propranolol or a neurological diagnosis will be excluded. All participants will receive education on the neuroscience of pain (video vignettes) and will participate in 6 weekly intervention sessions. During these sessions, they will receive propranolol or placebo capsules (double-blind; dosing based on size) and participate in a reactivation procedure (description and/or visualization of painful movements). Feasibility measures will be collected throughout the study; acceptability and efficacy measures will be assessed 4 weeks post-intervention, with the exception of physical function (primary efficacy measure), which will also be measured at each intervention session.
Relevance: This study will be the first to use reconsolidation blockade for the treatment of chronic pain. The postulated mechanism of action is plausible and supported by scientific evidence, but to date has never been tested in humans with persistent pain. If our results demonstrate that the intervention is feasible, acceptable, and has the potential to be effective, randomized clinical trials may follow our study to robustly evaluate the effect of our intervention in the short and long term. The intervention could also be evaluated in other chronic pain populations with central sensitization, such as pelvic pain, chronic neck pain (whiplash), etc.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Propranolol
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.
Propranolol Hydrochloride
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
Reactivation procedure
Description/visualization of painful movements/activities
Pain neuroscience education
In the form of 10 videos that participants will watch on their own time
Placebo
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.
Placebo
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
Reactivation procedure
Description/visualization of painful movements/activities
Pain neuroscience education
In the form of 10 videos that participants will watch on their own time
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Propranolol Hydrochloride
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
Placebo
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
Reactivation procedure
Description/visualization of painful movements/activities
Pain neuroscience education
In the form of 10 videos that participants will watch on their own time
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suffering from \[chronic low back pain OR fibromyalgia\] for \>6 months
* Average pain at least 4/10
* Central sensitization (assessed via a standardized physiotherapy evaluation and the Central Sensitization Inventory)
Exclusion Criteria
* Medication with which co-administration of propranolol is contra-indicated
* Severe or uncontrolled neurological/psychiatric condition (including post-traumatic stress disorder, substance abuse, suicidal ideation, etc.)
* Surgery of the lower-back in the last 3 years
* Litigation surrounding the painful condition
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université de Sherbrooke
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillaume Leonard, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre de recherche sur le vieillissement (CdRV)
Sherbrooke, Quebec, Canada
CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-4092
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.