Reconsolidation Therapy With Propranolol as a Novel Treatment for Chronic Pain : a Placebo-controlled Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Feasibility outcome 4 : % participants in each group who believe they received the experimental treatment (propranolol)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Propranolol
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Propranolol Hydrochloride (Drug)
Propranolol
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Reactivation procedure (Behavioral)
Propranolol
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Pain neuroscience education (Behavioral)
Placebo
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Placebo (Drug)
Placebo
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Reactivation procedure (Behavioral)
Placebo
- Pain neuroscience education (10 short videos - 2 to 4 mins each)
- 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.
干预措施: Pain neuroscience education (Behavioral)
结局指标
主要结局
Feasibility outcome 4 : % participants in each group who believe they received the experimental treatment (propranolol)
时间窗: At follow-up (on average,12 weeks after recruitment)
This percentage will be compared between the two groups to assess blinding
Acceptability outcome 2 : perceived ethicality of the intervention (prospective and retrospective)
时间窗: 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 2 : Rate of study completion
时间窗: 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.
Feasibility outcome 1 : Weekly recruitment rate
时间窗: 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 3 : Number of participants with adverse events (observed and self-reported)
时间窗: 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
Acceptability outcome 1 : perceived burden of the intervention (prospective and retrospective)
时间窗: 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 3 : perceived coherence of the intervention (prospective and retrospective)
时间窗: 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)
时间窗: 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 5 : perceived self-efficacy relating to the intervention (prospective and retrospective)
时间窗: 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)
次要结局
- Change in Emotional functioning(From baseline to follow-up (on average, 12 weeks))
- Change in Physical functioning(From baseline to follow-up (approx 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))
- Change in Pain intensity(From baseline to follow-up (approx 12 weeks))
- Participant ratings of global improvement and satisfaction with treatment(Follow-up (on average, 12 weeks after recruitment))