Clinical trial NCT05726266: Effect and Safety of Listening to Music for Chronic Pain Relief
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Music
Chronic Pain
Chronic Non-Cancer Pain
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All included patients must be under regular (maintenance) opioid treatment for at least one month before randomization. Included patients will be randomized (1:1) either to the control (audiobooks) or to the experimental (music) group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity measured by the Visual Analog Scale
timeFrame: 4 weeks
measure: Pain intensity differences from baseline during the 4 weeks of treatment
timeFrame: 4 weeks
measure: Scores on the McGill Multidimensional Pain Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in pain intensity considering alternative definitions of responder (also measured by the Visual Analog Scale)
timeFrame: 4 weeks
measure: Requirement of rescue analgesia
timeFrame: 4 weeks
measure: Change of status according to the Hospital Anxiety and Depression Scale (HADS) scores between the baseline and end-of-treatment visits.
timeFrame: 4 weeks
measure: Mean Total Mood Disturbance (TMD) scores (measured by the Profile of Mood States [POMS]) between the baseline and end-of-treatment visits.
timeFrame: 4 weeks
measure: Mean change in the Patient Global Impression of Change (PGIC) scores between the baseline and end-of-treatment visits.
timeFrame: 4 weeks
measure: Mean change in the Short-Form 36 (SF-36) scores between the baseline and end-of-treatment visits.
timeFrame: 4 weeks
measure: Change in the EuroQoL - 5 Dimensions - 5 Levels (EQ-5D-5L) scores between the baseline and end-of-treatment visits.
timeFrame: 4 weeks
measure: Number of adverse events by treatment arm.
timeFrame: 4 weeks
measure: Number of side effects derived from opioid use (UKU scale)
timeFrame: 4 weeks
measure: Number of adverse events related to the treatments under study (music therapy or audiobooks).
timeFrame: 4 weeks
measure: Mean change in the Opioid Risk Tool (ORT) score
timeFrame: 4 weeks
measure: Mean change in the Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) questionnaire score.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Anesthesiologist at Bellvitge University Hospital
name: Ancor S Alfonso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
citation: Zimmer Z, Fraser K, Grol-Prokopczyk H, Zajacova A. A global study of pain prevalence across 52 countries: examining the role of country-level contextual factors. Pain. 2022 Sep 1;163(9):1740-1750. doi: 10.1097/j.pain.0000000000002557. Epub 2021 Dec 15.
citation: Hopkins RE, Degenhardt L, Campbell G, Farnbach S, Gisev N. "Frustrated with the whole system": a qualitative framework analysis of the issues faced by people accessing health services for chronic pain. BMC Health Serv Res. 2022 Dec 31;22(1):1603. doi: 10.1186/s12913-022-08946-8.
citation: Breivik H, Eisenberg E, O'Brien T; OPENMinds. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health. 2013 Dec 24;13:1229. doi: 10.1186/1471-2458-13-1229.