Chronic Low-back Pain, Fibromyalgia
Conditions
Keywords
Chronic pain, Reconsolidation therapy, Propranolol, 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.
Interventions
DRUGPropranolol Hydrochloride
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
DRUGPlacebo
6 weekly doses (40 to 80 mg) 1h before the reactivation procedure
BEHAVIORALReactivation procedure
Description/visualization of painful movements/activities
BEHAVIORALPain neuroscience education
In the form of 10 videos that participants will watch on their own time
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability outcome 5 : perceived self-efficacy relating to the intervention (prospective and retrospective) | Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment) | Rated on an 11-point numerical rating scale (0-10; 10 = better outcome) |
| Feasibility outcome 3 : Number of participants with adverse events (observed and self-reported) | Through data collection phase (estimated 6 months per population) | For all adverse even, the following will be reported : Type & severity (according to the CTCAE), attribution, expected vs unexpected |
| Feasibility outcome 4 : % participants in each group who believe they received the experimental treatment (propranolol) | At follow-up (on average,12 weeks after recruitment) | This percentage will be compared between the two groups to assess blinding |
| Acceptability outcome 1 : perceived burden of the intervention (prospective and retrospective) | Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment) | Rated on an 11-point numerical rating scale (0-10; 10 = worse outcome) |
| Acceptability outcome 2 : perceived ethicality of the intervention (prospective and retrospective) | Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment) | Rated on an 11-point numerical rating scale (0-10; 10 = better outcome) |
| Acceptability outcome 3 : perceived coherence of the intervention (prospective and retrospective) | Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment) | Rated on an 11-point numerical rating scale (0-10; 10 = better outcome) |
| Acceptability outcome 4 : perceived effectiveness of the intervention (prospective and retrospective) | Prospective rating : at baseline ; Retrospective rating : at follow-up (on average,12 weeks after recruitment) | Rated on an 11-point numerical rating scale (0-10; 10 = better outcome) |
| Feasibility outcome 1 : Weekly recruitment rate | Through recruitment phase (estimated 3 months per population) | Number of prospective participants successfully recruited every week, vs number of participants excluded and number of refusals |
| Feasibility outcome 2 : Rate of study completion | Through data collection phase (estimated 6 months per population) | Percentage of sample with perfect attendance vs partial attendance vs withdrawal vs exclusion vs loss to follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain intensity | From baseline to follow-up (approx 12 weeks) | Measured using the self-reported Brief pain inventory (short form) (0-40; 40 = worse outcome) |
| Change in Emotional functioning | From baseline to follow-up (on average, 12 weeks) | Measured using the self-reported Profile of mood states (-32 to 200; 200 = worse outcome) |
| Change in Central sensitization | From baseline to follow-up (on average, 12 weeks) | Measured using the self-reported Central sensitization inventory (0-100; 100=worse outcome) |
| Change in Symptoms of fibromyalgia | From baseline to follow-up (on average, 12 weeks) | Measured using the self-reported Fibromyalgia impact questionnaire(for the fibromyalgia population only) (0=100; 100 = worse outcome) |
| Participant ratings of global improvement and satisfaction with treatment | Follow-up (on average, 12 weeks after recruitment) | Measured using the self-reported Patient global impression of change (1-7; 7 = better outcome) |
| Change in Physical functioning | From baseline to follow-up (approx 12 weeks) | Measured using the self-reported Brief pain inventory (short form); (0-70; 70 = worse outcome) |
Countries
Canada
Outcome results
None listed