Clinical trial NCT05085782: Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain
Official title: Reconsolidation Therapy With Propranolol as a Novel Treatment for Chronic Pain : a Placebo-controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Low-back Pain
Fibromyalgia
Keywords: Chronic pain
Reconsolidation therapy
Propranolol
Treatment
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility outcome 1 : Weekly recruitment rate
timeFrame: Through recruitment phase (estimated 3 months per population)
measure: Feasibility outcome 2 : Rate of study completion
timeFrame: Through data collection phase (estimated 6 months per population)
measure: Feasibility outcome 3 : Number of participants with adverse events (observed and self-reported)
timeFrame: Through data collection phase (estimated 6 months per population)
measure: Feasibility outcome 4 : % participants in each group who believe they received the experimental treatment (propranolol)
timeFrame: At follow-up (on average,12 weeks after recruitment)
measure: Acceptability outcome 1 : perceived burden of the intervention (prospective and retrospective)
timeFrame: Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)
measure: Acceptability outcome 2 : perceived ethicality of the intervention (prospective and retrospective)
timeFrame: Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)
measure: Acceptability outcome 3 : perceived coherence of the intervention (prospective and retrospective)
timeFrame: Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)
measure: Acceptability outcome 4 : perceived effectiveness of the intervention (prospective and retrospective)
timeFrame: Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)
measure: Acceptability outcome 5 : perceived self-efficacy relating to the intervention (prospective and retrospective)
timeFrame: Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment)
Secondary outcomes:
measure: Change in Physical functioning
timeFrame: From baseline to follow-up (approx 12 weeks)
measure: Change in Pain intensity
timeFrame: From baseline to follow-up (approx 12 weeks)
measure: Change in Emotional functioning
timeFrame: From baseline to follow-up (on average, 12 weeks)
measure: Change in Central sensitization
timeFrame: From baseline to follow-up (on average, 12 weeks)
measure: Change in Symptoms of fibromyalgia
timeFrame: From baseline to follow-up (on average, 12 weeks)
measure: Participant ratings of global improvement and satisfaction with treatment
timeFrame: Follow-up (on average, 12 weeks after recruitment)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement (CdRV)
state: Quebec
city: Sherbrooke
country: Canada
facility: CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Guillaume Leonard, PhD
role: PRINCIPAL_INVESTIGATOR
References: