A pilot randomized controlled trial of effectiveness of a psychoeducational intervention on the management of musculoskeletal chronic noncancer pain

PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 1 A Pilot Randomized Controlled Trial of Effectiveness of a Psychoeducational Intervention on the Management of Musculoskeletal Chronic Non-Cancer Pain Background The prevalence of musculoskeletal chronic non-cancer pain (mCNCP) is continually growing. The control of symptoms is sometimes refractory to pharmacological treatment or other interventions. The lack of clinical control entails a high consumption of health resources with a great economic impact (Dueñas et al., 2015; Gauthier et al., 2019). In the Global Burden of Disease Study, the authors concluded that pain and associated health problems were the leading cause of disability worldwide (James et al., 2018). Many people with mCNCP experience stress, fear and depression (Cáceres-Matos et al., 2020; Sheng et al., 2017). These emotions act as aggravating factors and amplify the perception of pain (Esteve et al., 2020). As a result, the same stimulus produces more suffering and creates a vicious circle. Psychoeducation is a therapeutic approach in which patients and/or their families receive specific information about the knowledge and essential aspects of the disease. Psychoeducation goes far beyond just providing information, it aims, from a bio-psycho- social perspective, to modify attitudes or behaviors of the patient, family or caregiver, a situation that allows them to better adapt to the disease through changes in their lifestyle, in their cognitions about the disease, in adherence to treatment, in the management of triggers or in the early detection of relapses. With psychoeducation it is possible to implement strategies for promotion, prevention and nursing care not only for the individual, but also for the family in order to provide comprehensive care (Cuevas-Cancino PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 2 & Moreno-Pérez, 2017). Within psychoeducation, previous systematic reviews suggest that body-mind therapies (Hilton et al., 2017; Skelly et al., 2020) and pain neurosciencebased education show benefits in different conditions of CNCP (Cuenda Gago & Espejo Antúnez, 2017; Patel et al., 2020). With the focus on the role of hypervigilance and emotional reactivity, the cognitive behavioural therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) approaches can be very helpful in managing chronic pain. Patients following these practices focus on participating in activities that are worthwhile and finding personally relevant goals, improving their ability to cope with their situation (Cano-García et al., 2017; Kratz et al., 2018). In the context of a growing interest in reducing the use of opioids, it is also important to determine if one of the results of psychological approaches is the reduction of drug use. Although this is one of the assumed benefits, studies on the association between self-management interventions and analgesic dependence are lacking. Data on the effects of behavioural intervention on the use of pain medications are very scarce but initially point to a reduction in their consumption (Hassan et al., 2020; Kratz et al., 2018). There is also evidence of greater savings and cost-effectiveness of integrated care in the mCNCP compared to the conventional therapeutic approach (Palylyk-Colwell & Wright, 2019). Interdisciplinary care should encourage the active role of patients in their own health. To achieve this, it is necessary for the patients to acquire knowledge and skills for self-management and coping with their illness. Therefore, we proposed the development of a randomized clinical trial to analyze the effects of psychoeducation in the clinical management of CNCPm. To this end, we proposed this preliminary pilot study with the main objective of collecting preliminary data that would allow us to evaluate the efficacy PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 3 of a psychoeducational intervention (PI) on pain intensity in patients with CNCPm and to carry out an adequate design of the future randomized clinical trial. As secondary objectives, we analyzed the effect of the intervention on quality of life (QoL), on treatment with strong opioids and the post-intervention satisfaction index. We also assessed whether any baseline sociodemographic or clinical characteristics of the patient influenced the results. The data obtained have helped to detect weaknesses and strengths in the development of the study, to develop a design adapted to these findings and to estimate the sample size necessary for the reliability of the results of the future clinical trial. Methods Design Two arms parallel randomized pilot study designed following the CONSORT 2010 Statement: Extension to Randomized Pilot and Feasibility Trials guideline (Eldridge et al., 2016). Ethical Approval, Informed Consent and Data Research This work was carried out in accordance with The Code of Ethics of the World Medical Association for experiments involving humans (Declaration of Helsinki)(WMA Declaration of HELSINKI – Ethical Principles for Medical Research Involving Human Subjects., 2018) and it was approved by the Ethics Committee of the Virgen Macarena- Virgen del Rocio University Hospitals in Seville (code: blinded) and registered at ClinicalTrial.gov (NCT-blinded). The informed consent document consultation is available at https://blinded. Eligibility Criteria for Participants PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 4 Inclusion Criteria: Patients over 18 years of age, with mCNCP with moderatesevere intensity, without any improvement with the pharmacological treatment, treated for this reason in the Primary Health Centers of the Public System, and without communication problems in oral or written Spanish. Patients were excluded if they had: followed out-of-hospital therapy similar to that in this study; suffered an accident, surgery or new injuries that could increase the perception of pain during the study, presented a severe or decompensated systemic disease, active cancer, severe mental illness, drug addiction or suicidal ideation. Recruitment, Randomization and Blinding The patients were informed and recruited by a physiotherapy specialist from the Hospital's Physiotherapy Department through their identification in the registry of patients with chronic non-cancer pain. This professional arranged a meeting with the patients, explaining the nature of the appointment. Once at the Hospital, he explained to them what the study consisted of verbally and in writing, answered the patients' doubts and offered them to participate. At that time, they signed the informed consent form. Patients who met the eligibility criteria, were informed, voluntarily agreed to participate and gave their signed consent were included. At that time, they were assigned an identification number to avoid exposing their personal data. That number would be the one used during the analysis of the results. A professional from the Research Department assigned the included patients to the control group (CG) or intervention group (IG) through a randomization sequence using random block sizes of 4. All study personnel that gathered data were blinded to which group participants were assigned to. Blinding of the participants could not be ensured as it was a face-to-face PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 5 psychoeducational intervention, but an attempt was made not to reveal the group to which the control group patients belonged until the intervention was completed in a month. Later they were informed of the group to which they belonged and invited to carry out the workshop. Participants Groups Intervention Group The IG received standard pharmacological treatment in Primary Health Centers aimed at controlling mCNCP with a PI. The intervention consisted of a face-to-face session of 3 hours, one per week, over a four-week period. This workshop was centered on training in emotional self-regulation in a group modality and with a participatory character. The content of the four sessions of the workshop is described in Table 1. The design of each session was generated by the authors based on their previous knowledge and experiences. Control Group The CG received standard pharmacological treatment in Primary Health Centers aimed at controlling mCNCP without PI. Although our intention was to offer the control group the opportunity to participate in the PI after completion of the study, the onset of the pandemic and the restrictions imposed made this impossible. The two professionals who teach the workshops, in addition to their medical specialties, have university training in Pain Neuroscience and Coaching. Outcomes Primary Outcome Measures Pain intensity by the Verbal Numerical Rating Scale (VNRS). This scale will be used for its simplicity and reproducibility. In patients without cognitive PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 6 impairment, it has a compliance close to 100% (Hjermstad et al., 2011). Quantification is on a scale from 0 to 10, where 0 is painlessness and 10 is as much pain as possible. Secondary Outcome Measures Anthropometric variables. Age (years), gender (male/female), weight (kilograms), height (centimeters) and body mass index (BMI). The BMI will be expressed in kilograms of weight/(height in meters)2. Sociodemographic data. Educational level, marital status and employment situation. Characterization of pain. Location, evolution time (months) and if another type of pain coexists with mCNCP. Concomitant chronic pathology. The existence of conditions associated with unhealthy lifestyles such as smoking and obesity have been considered in this study as factors that could increase the intensity of musculoskeletal pain (Dai et al., 2021; Eichwald & Talbot, 2020). Anxiety or depressive traits recognized by the patients themselves have also been considered, since they interfere with the patients' positive adaptive behaviours, which could worsen the clinical situation (Cáceres- Matos et al., 2020; Sheng et al., 2017). QoL by the EuroQol-5D questionnaire (EQ-5D). With five dimensions (mobility, self-care, habitual activities, pain/discomfort and anxiety/depression) the answers values ranging from 0 for worst possible health and 1 for perfect health. The EQ-5D questionnaire also includes a visual analogue scale (VAS) with a score ranging from 0 (the worst health status possible) to 100 (the best health status PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 7 possible) (Balestroni & Bertolotti, 2012). Therefore, improvements over time are expressed as negative values and differences with positive values indicate clinical worsening. Pharmacological treatment with any type of strong opioids (morphine, oxycodone, methadone, hydromorphone, tapentadol, fentanyl and buprenorphine) (Anekar & Cascella, 2022). It was evaluated by the answer "yes" or "no". Level of satisfaction about PI. It was assessed by an anonymous questionnaire (only in the intervention group after the last PI session). The quantification is on a scale of 0 to 100, where 0 is the worst satisfaction and 100 the best possible satisfaction. An additional open-ended question was included to address the experience and perceived impact of the intervention on their recovery. This questionnaire also asked if they would be willing, once they had learned the content of the workshop, to repeat the experience. Assessment A Hospital Physiotherapy Department professional administered all the questionnaires at the time of inclusion and at one month. Data at baseline and the followon assessment were collected at the hospital in writing. Potential participants were identified between September 2019-December 2019. The workshop was made in January- 2020 and the follow-up finished in February-2020. It was planned to carry out an evaluation three months after the start of the study, which due to the start of the COVID pandemic could not be carried out due to the mobilization of the study professionals to the care units PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 8 for infected patients. Even so, patients were informed by telephone of the interruption of the study. Most reported a high level of anxiety due to social isolation, and some had been infected or had lost a loved one. We consider that this situation derived from the pandemic could have acted as a confounding variable that would affect all the results. No other important changes to methods after pilot trial commencement were necessary. Statistical Methods A descriptive analysis of all the variables was carried out. Qualitative variables were presented by absolute and relative frequencies. Quantitative variables were presented by the mean and standard deviation (SD). In the second stage, an intention to treat analysis was developed. All variables were tested for normality. The two groups were compared with the chi-square test for dichotomous variables and the two-sample t-test for continuous variables. Change scores were generated between the pre-intervention measures and the post-intervention measures for the IG and CG and a two samples t-test was used to establish the significance of change between the groups. Cohen’s d was used to calculate the effect size difference between psychoeducation and control group. In the estimation of effect sizes, the outcome variables of interest were pain intensity and QoL (VAS and global score). The sample size was established based on the capacity of the facility for 25 people. This pilot study was developed, rather than to detect differences in outcome measures between groups, to inform sample size calculations for a future full power randomized controlled trial. In the future clinical trial, the number of participants per workshop will be modified in accordance with the COVID regulations at that time. PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 9 The level of statistical significance was set at p less than 0.05. Statistical analysis will be performed using the SPSS package, version 26.0 and R Studio. Results Baseline participants characteristics During the recruitment period, 63 participants were proposed to participate in the study. Of these, 23 declined to participate and two did not strictly meet the inclusion criteria. Figure 1, developed from the CONSORT statement, shows the progression of subjects throughout the treatment study. The baseline characteristics of each group are shown in Table 2. The final number of participants was 37, 19 in the intervention group and 18 in the control group. The total sample was predominantly female (83.7%) and had a mean age of 53.11 years (SD 10.36). The most frequent marital status was married (70.3%) and below the university education level (86.4%). Regarding the clinical characteristics, the mean intensity of pain measured by VNRS was 8.27 (SD 1.37), the meantime of evolution of the painful condition was 59.67 months (SD 84), 62.1% of the sample presented anxiety or depressive trait, 21.6% used some type of strong opioid and 51.3% of the sample had had some type of recognized sick leave due to pain before starting the study. More than half of the sample (67.5%) had a body mass index (BMI) greater than 24 and 27% were active smokers. There were no significant differences between the intervention and control groups in terms of anthropometric, sociodemographic, and clinical characteristics, except for strong opioid use. Patients using opioids had significantly higher baseline pain intensity (VNRS) than non-users (opioids: mean 9.12 ± 0.99; non-opioids: mean 8 ± 1.38; p = 0.02). No baseline differences were found in the QoL parameters. Post-Intervention Outcomes PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 16 Although there are some restrictions regarding the interpretation of the results, this study has some strengths. One of them is the availability of a control group that has reinforced the results obtained through the intervention. Another point is the detailed description of an effective intervention for the management of chronic pain that can be used in different contexts. It could even be adapted to Telemedicine since recent evidence also supports the effectiveness of psychoeducational interventions in this modality (Sánchez‐Gutiérrez et al., 2022). Some patients with musculoskeletal chronic non-cancer pain may experience an exacerbation of symptoms as a result of the COVID-19 pandemic. Specialist pain management clinics or consultations may be closed or less accessible, with long waiting times. Health professionals may be sick or diverted to activities related to COVID-19. In addition to fearing infection in a public facility, patients may not be able to access muchneeded physical rehabilitation programs in gyms and swimming pools to control pain (Clauw et al., 2020). Following the major challenges faced by the healthcare system during the pandemic, new forms of care must be promoted. Patient attendance at health centers and the consumption of drugs with significant side effects such as opioids should be reduced. It is necessary to place the patient at the center of care with tools for selfregulation and the development of better coping through positive adaptive behaviours. This study has some limitations. In the first place, the size of the sample is small since at the end of the first workshop the COVID-19 pandemic began, which prevented face-to-face attention. Despite this, it has provided us with sufficient information to determine the sample size necessary for a future randomized clinical trial. Second, with no follow-up data, the duration of therapeutic effects is unknown. Long-term follow-up was PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 17 not possible since, like many research teams, the professionals involved in this study had to care for COVID-19 patients in the first wave. Third, the difficulty of blinding participants in a face-to-face intervention compared to a control group. The fact that the professionals who gave the workshops were not licensed psychologists could be thought of as a drawback, but the professionals had university training in neuroscience, pain management and coaching. Previous clinical trials of psychoeducational interventions in chronic diseases describe how lay counsellors in psychology have developed them with positive clinical effects (Sánchez‐Gutiérrez et al., 2022). Conclusions and Clinical Implications In conclusion, the results of this pilot study suggest an initial benefit of the psychoeducation program in patients with musculoskeletal chronic non-cancer pain, with an improvement in pain intensity and quality of life, which was accompanied by a reduction in the use of strong opioids. Psychoeducational interventions are a promising nonpharmacologic adjunct to current pain management in older adults. Pilot testing of the psychoeducational intervention indicated that it was well accepted by participants and feasible when done in a group setting. The promising outcomes of this study, despite the limitation of the small sample size, support a future definitive clinical trial in which an initial biopsychosocial evaluation and long-term follow-up will be carried out after the intervention. If the results are as expected, this model of care will benefit the patient and save resources for the public health system, such as opioid prescriptions. Better self-management could also reduce visits and trips to Health Centers, something highly desirable, if not necessary, in the face of the COVID-19 pandemic. On the other hand, knowing the characteristics of patients who PSYCHOEDUCATION IMPACT ON CHRONIC NON-CANCER PAIN 18 respond to psychoeducational interventions with positive adaptive responses will help to identify them in the future and will allow intervention at an earlier stage to improve outcomes and reduce resource consumption. The need to offer other alternatives for the treatment of chronic non-cancer pain is based on the recommendation of a multimodal and multidisciplinary approach given the multidimensional nature of pain perception. Nurses, within the multidisciplinary team, are identified as one of the key professionals for the treatment of pain, since they are the healthcare professional who is in continuous contact with the patient. 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