Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain

NCT05085782 | Completed Phase 2 DMC

• 1 other identifier: 2022-4092
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of this study is to document the feasibility and acceptability of an intervention consisting of pain neuroscience education and reconsolidation therapy with propranolol in adults suffering from chronic pain (chronic low back pain or fibromyalgia). 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.

Conditions

Chronic Low-back Pain; Fibromyalgia

Keywords

Chronic pain; Reconsolidation therapy; Propranolol; Treatment

Outcome Measures

Primary Outcomes (9)

• Feasibility outcome 1 : Weekly recruitment rate

  Number of prospective participants successfully recruited every week, vs number of participants excluded and number of refusals

  Through recruitment phase (estimated 3 months per population)

• Feasibility outcome 2 : Rate of study completion

  Percentage of sample with perfect attendance vs partial attendance vs withdrawal vs exclusion vs loss to follow-up.

  Through data collection phase (estimated 6 months per population)

• Feasibility outcome 3 : Number of participants with adverse events (observed and self-reported)

  For all adverse even, the following will be reported : Type \& severity (according to the CTCAE), attribution, expected vs unexpected

  Through data collection phase (estimated 6 months per population)

• Feasibility outcome 4 : % participants in each group who believe they received the experimental treatment (propranolol)

  This percentage will be compared between the two groups to assess blinding

  At follow-up (on average,12 weeks after recruitment)

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

  Rated on an 11-point numerical rating scale (0-10; 10 = worse outcome)

  Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)

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

  Rated on an 11-point numerical rating scale (0-10; 10 = better outcome)

  Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)

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

  Rated on an 11-point numerical rating scale (0-10; 10 = better outcome)

  Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)

• Acceptability outcome 4 : perceived effectiveness of the intervention (prospective and retrospective)

  Rated on an 11-point numerical rating scale (0-10; 10 = better outcome)

  Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)

• Acceptability outcome 5 : perceived self-efficacy relating to the intervention (prospective and retrospective)

  Rated on an 11-point numerical rating scale (0-10; 10 = better outcome)

  Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)

Secondary Outcomes (6)

• Change in Physical functioning

  From baseline to follow-up (approx 12 weeks)

• Change in Pain intensity

  From baseline to follow-up (approx 12 weeks)

• Change in Emotional functioning

  From baseline to follow-up (on average, 12 weeks)

• Change in Central sensitization

  From baseline to follow-up (on average, 12 weeks)

• Change in Symptoms of fibromyalgia

  From baseline to follow-up (on average, 12 weeks)

Study Arms (2)

Propranolol

EXPERIMENTAL

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.

Drug: Propranolol Hydrochloride; Behavioral: Reactivation procedure; Behavioral: Pain neuroscience education

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Behavioral: Reactivation procedure; Behavioral: Pain neuroscience education

Interventions

Propranolol Hydrochloride DRUG

6 weekly doses (40 to 80 mg) 1h before the reactivation procedure

Also known as: Experimental group

Propranolol

Placebo DRUG

6 weekly doses (40 to 80 mg) 1h before the reactivation procedure

Also known as: Control group

Placebo

Reactivation procedure BEHAVIORAL

Description/visualization of painful movements/activities

Placebo; Propranolol

Pain neuroscience education BEHAVIORAL

In the form of 10 videos that participants will watch on their own time

Placebo; Propranolol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• French speaking
• 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)

You may not qualify if:

• Health condition for which propranolol is contra-indicated
• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, J1H 4C4, Canada

Location

CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Propranolol; Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Guillaume Leonard, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 20, 2021
• Study Start: February 7, 2022
• Primary Completion: December 30, 2024
• Study Completion: August 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)