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Chronic Low-back PainPhase 2NCT05085782

Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain

A Phase 2 study testing Propranolol Hydrochloride, Reactivation procedure and Pain neuroscience education in people with Chronic Low-back Pain and Fibromyalgia, run by Université de Sherbrooke at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Low-back Pain, Fibromyalgia
What is being tested?
Propranolol Hydrochloride, Reactivation procedure and Pain neuroscience education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
2 sitesCanada
Study dates
7 Feb 2022to 31 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre de recherche sur le vieillissement (CdRV)

    Sherbrooke, Quebec, J1H 4C4

  • CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

About this study

Official title: Reconsolidation Therapy With Propranolol as a Novel Treatment for Chronic Pain : a Placebo-controlled Feasibility Study

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.

Read the detailed description

Background: Many patients with chronic pain exhibit abnormal synaptic changes in the central nervous system - including hyperactivity in the amygdala - reminiscent of those seen in post-traumatic stress disorder (PTSD). A recently developed psychiatric treatment for PTSD involves reactivating the synapses to make them temporarily malleable and then blocking their reconsolidation with propranolol, thereby reducing the hyperactivity in the amygdala and decreasing the intensity of the symptoms in a lasting way. Considering the similarities between PTSD and chronic pain, this treatment could also be beneficial for patients with chronic pain.

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.

Being tested
Propranolol Hydrochloride, Placebo, Reactivation procedure, Pain neuroscience education
Keywords
Chronic pain, Reconsolidation therapy, Propranolol, Treatment
Medical subject headings
Fibromyalgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propranolol HydrochlorideDrug

    Also called Experimental group

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

  • PlaceboDrug

    Also called Control group

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

  • Reactivation procedureBehavioural

    Description/visualization of painful movements/activities

  • Pain neuroscience educationBehavioural

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

Study groups in NCT05085782
Study groupRoleWhat they receive
PropranololExperimental1. 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.
Receives: Drug: Propranolol Hydrochloride; Behavioral: Reactivation procedure; Behavioral: Pain neuroscience education
PlaceboPlacebo comparator1. 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.
Receives: Drug: Placebo; Behavioral: Reactivation procedure; Behavioral: Pain neuroscience education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility outcome 1 : Weekly recruitment rate

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

    Measured: Through recruitment phase (estimated 3 months per population)

  2. 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.

    Measured: Through data collection phase (estimated 6 months per population)

  3. 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

    Measured: Through data collection phase (estimated 6 months per population)

  4. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

  9. 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)

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

Secondary outcomes (6)

  1. Change in Physical functioning

    Measured using the self-reported Brief pain inventory (short form); (0-70; 70 = worse outcome)

    Measured: From baseline to follow-up (approx 12 weeks)

  2. Change in Pain intensity

    Measured using the self-reported Brief pain inventory (short form) (0-40; 40 = worse outcome)

    Measured: From baseline to follow-up (approx 12 weeks)

  3. Change in Emotional functioning

    Measured using the self-reported Profile of mood states (-32 to 200; 200 = worse outcome)

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

  4. Change in Central sensitization

    Measured using the self-reported Central sensitization inventory (0-100; 100=worse outcome)

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

  5. Change in Symptoms of fibromyalgia

    Measured using the self-reported Fibromyalgia impact questionnaire(for the fibromyalgia population only) (0=100; 100 = worse outcome)

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

  6. Participant ratings of global improvement and satisfaction with treatment

    Measured using the self-reported Patient global impression of change (1-7; 7 = better outcome)

    Measured: Follow-up (on average, 12 weeks after recruitment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start7 Feb 2022
  3. Primary completion30 Dec 2024
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085782
Sponsor's protocol ID
2022-4092
Status last verified
Dec 2024
First submitted
27 Sep 2021
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coulombe-Leveque A, Lafrenaye S, Brunet A, Morin M, Marchand S, Leonard G. Reconsolidation blockade with propranolol as a novel treatment for fibromyalgia: A double-blind, randomized placebo-controlled feasibility study. J Pain. 2026 Jul 10;48:106375. doi: 10.1016/j.jpain.2026.106375. Online ahead of print.

    PubMed 42431386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol Hydrochloride, Reactivation procedure and Pain neuroscience education in people with Chronic Low-back Pain and Fibromyalgia, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility outcome 1 : Weekly recruitment rate (time frame: Through recruitment phase (estimated 3 months per population)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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