Effect and Safety of Listening to Music or Audiobooks as a Coadjunvant Treatment for Chronic Pain Patients Under Opioid Treatment: A Single-Center, Open-Label, Parallel Groups, Controlled, Randomized Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Scores on the McGill Multidimensional Pain Questionnaire
研究概览
简要总结
Chronic pain is a multidimensional pathological condition that reduces patients' quality of life and interferes with their daily family and work activities.
Opioids are the most powerful analgesics in the treatment of pain. They are used as a basic analgesic treatment for managing patients with chronic pain and as an analgesic treatment for managing breakthrough pain.
Chronic administration of opioids can cause significant side effects (e.g., dependence, constipation) and tolerance to their analgesic effects, limiting their use. Different behavioral therapies (e.g., mindfulness and cognitive therapy) have been proposed to potentiate the analgesic effects of opioids and, consequently, reduce the dose and the appearance of adverse effects. One of the proposed approaches consists of listening to music therapeutically as a cognitive tool that modulates attention and regulates mood. Some studies provide evidence that music can reduce opioid requirements in patients with chronic pain. On the other hand, both opioids and music activate brain circuits for reward, reinforcement, and motivation.
Preliminary results obtained by our research group in animal models suggest that listening to music can reduce the appearance of a withdrawal syndrome after chronic administration of opioids.
Our working hypothesis is that multimodal therapy, based on listening to music as an adjuvant treatment to regular analgesic treatment with opioids, reduces pain intensity and its harmful effects in patients diagnosed with chronic non-cancer pain. Hence, the daily amount of opioids taken will be reduced, as well as the likelihood of developing opioid tolerance, dependence, and other opioid-related adverse events. At the same time, these patients' emotional well-being and quality of life will improve.
This is a parallel-group, open-label, single-center randomized, pilot, controlled clinical trial that aims to evaluate the effect and safety of music as a coadjuvant treatment for chronic non-cancer pain.
详细描述
Chronic non-cancer pain (CNCP) is defined as pain lasting from three to six months or persisting for longer than expected for tissue healing or underlying disease resolution [López, 2014]. Other authors define it as pain lasting for more than three months, continuously or intermittently, present more than five days a week, with moderate or high intensity on the visual analog scale (VAS), and/or impairing one's functional capacity [Guerra de Hoyos, 2014].
The World Health Organization (WHO) estimates that 20% of the world population suffers from chronic pain to some degree [Turk, 2011]. Moreover, CNCP impacts patients' quality of life substantially, affecting physical and psychosocial dimensions and interfering with daily-life activities. It also poses a heavy burden on health and social security services by increasing healthcare and economic aid demand for lost days at work [Breivik, 2013; Zimmer, 2021; Hopkins, 2022].
The main objective of the treatment is to maintain physical and mental functionality while improving quality of life. This may require a multimodal approach, including, in addition to medication, other interventions such as psychological therapy, active physiotherapy, movement therapy, or percutaneous electrostimulation, among others [Turk; 2011]. However, opioid use has been on the rise in the last few years, and its use is not free from adverse events.
Our working hypothesis is that a multimodal therapy, based on listening to music as a coadjuvant treatment to maintenance analgesic treatment with opioids, reduces pain intensity in patients diagnosed with CNCP. As a result, the daily amount of opioids taken will be reduced, as well as the likelihood of developing opioid tolerance, dependence, and other opioid-related adverse events. At the same time, these patients' emotional well-being and quality of life will improve.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ≥18 years of age.
- •Diagnosed with Chronic Non-Oncological Pain.
- •Under regular (maintenance) opioid treatment for at least one month.
- •Patients who sign the written informed consent.
排除标准
- •Pregnant or lactating women.
- •History of an organic brain disorder or substance abuse/dependence.
- •History of Psychotic disorder, bipolar disorder, and/or intellectual disability.
- •Patients at risk of opioid addiction.
- •Patients that the Pain Clinic physician or psychologist believe will not comply with the study treatment/procedures.
结局指标
主要结局
Scores on the McGill Multidimensional Pain Questionnaire
时间窗: 4 weeks
The McGill Multidimensional Pain Questionnaire scores range from 0 (No Pain) to 78 (Severe Pain). Changes between the baseline and end-of-treatment scores will be assessed.
Pain intensity differences from baseline during the 4 weeks of treatment
时间窗: 4 weeks
We will assess the mean pain intensity differences from baseline during the 4 weeks of treatment. These mean pain intensity differences will be used to obtain the sum of pain intensity differences (by calculating the area under the time-analgesic effect curve).
Pain intensity measured by the Visual Analog Scale
时间窗: 4 weeks
The Visual Analog Scale is a continuous variable on a 10 cm line representing "no pain" (0 cm) to "worst imaginable pain" (10 cm). We will consider as responders those patients with a ≥30% reduction in the "maximum pain intensity in the last 24 hours" at any time during the study compared to the baseline score (study start visit) for at least 3 consecutive days.
次要结局
- Mean Total Mood Disturbance (TMD) scores (measured by the Profile of Mood States [POMS]) between the baseline and end-of-treatment visits.(4 weeks)
- Requirement of rescue analgesia(4 weeks)
- Change of status according to the Hospital Anxiety and Depression Scale (HADS) scores between the baseline and end-of-treatment visits.(4 weeks)
- Change in pain intensity considering alternative definitions of responder (also measured by the Visual Analog Scale)(4 weeks)
- Number of side effects derived from opioid use (UKU scale)(4 weeks)
- Number of adverse events related to the treatments under study (music therapy or audiobooks).(4 weeks)
- Mean change in the Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) questionnaire score.(4 weeks)
- Mean change in the Patient Global Impression of Change (PGIC) scores between the baseline and end-of-treatment visits.(4 weeks)
- Mean change in the Short-Form 36 (SF-36) scores between the baseline and end-of-treatment visits.(4 weeks)
- Change in the EuroQoL - 5 Dimensions - 5 Levels (EQ-5D-5L) scores between the baseline and end-of-treatment visits.(4 weeks)
- Number of adverse events by treatment arm.(4 weeks)
- Mean change in the Opioid Risk Tool (ORT) score(4 weeks)
研究者
Sebastian Videla
Head of the Clinical Research Support Unit
Hospital Universitari de Bellvitge