Effectiveness of Coping Strategies on the Control of Musculoskeletal Chronic Non-Cancer Pain and Quality of Life: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change from Baseline Pain perception
研究概览
简要总结
- Introduction and objectives: Non-pharmacological interventions in patients with musculoskeletal chronic non-cancer pain (mCNCP) are positioning themselves as an essential pillar in treatment along with pharmacological and interventional treatment. Training the patient in psycho-educational interventions focused on the neuroscience of pain and accompanying them towards a better coping of their disease can decrease the perception of pain and improve their quality of life. A previous pilot study, developed by the researchers about this type of interventions, identified as relevant data an improvement in the quality of life (QoL) of patients with mCNCP with a significant decrease in pharmacological consumption, and a high degree of satisfaction on the part of the user through the analysis of PROMs (patient-reported outcome measures). The main objective of this study is to know the effectiveness in the perception of pain through the Verbal Numerical Rating Scale (VNRS) and in the quality of life through the EuroQol-5D (EQ-5D) questionnaire of a psychoeducational intervention focused on emotional coping strategies, in patients with mCNCP in the Primary Care Centres of Public Health System of Aljarafe-Sevilla Norte Area (Spain). Secondarily, the consumption of health resources associated with mCNCP, the adherence to treatment, the influence of social, emotional, and family variables will be studied by the researchers in the two groups of patients on each telephone assessment.
- Methodology: Prospective, randomized, triple-blind (patient, investigator, and analysis) and controlled clinical trial. Participants with mCNCP in follow-up in Primary Care without clinical control with the treatment scheduled and who agree to participate in the study will be randomized by blocks permuted to receive treatments and standard care (control group) or these same care plus a psychoeducational intervention (experimental group). This intervention consists of an emotional self-regulation training program of four face-to-face sessions of 3 hours each, over a four-week period. The study will include 144 participants (72 for each arm). Patient follow-up will be telephone at the time of inclusion, at month, three, and six months. A descriptive and multivariate analysis will be done with the patients' research data associated with pain or QoL, post-intervention.
- Ethics and dissemination: The study will be carried out following the Helsinki Declaration and is approved by the Committee on Ethics of Research of Virgen Macarena- Virgen del Rocío university hospitals in Seville, Spain (code 1589-N-19). The results of the trial will be published under CONSORT regulations and SPIRIT guideline.
详细描述
- BACKGROUND AND RATIONALE
Many people with mCNCP experience stress, fear and depression. These emotions, mental states and their associated behaviours often act as aggravating factors, amplifying the perception of pain (1-3). As a result, the same stimulus produces more suffering and begins a vicious circle. In this context, the acceptance and engagement therapy (ACT) and mindfulness-based stress reduction (MBSR) can be very helpful in managing chronic pain. These practices allow the patients to focus on participating in valuable activities and finding personally relevant objectives, improving their coping in this situation.
Based on systematic reviews the investigators can confirm that body-mind therapies, especially MBSR and pain neuroscience education show benefits in a different kind of noncancer chronic pain in the adult such as reducing the severity of pain and functional limitation, maintaining the positive effects in the long term. On the other hand, related to a growing interest in reducing the use of opioid medications, it is also important to determine if one of the results of psychological approaches is the decrease in drug use, and as a consequence, a decrease in health cost per patient. Although this is one of the benefits assumed, studies about the association between pain management or self-control interventions and dependence on painkillers are lacking. There are not enough data about the behavioral intervention effects on the use of pain medication but initially points to a reduction. Therefore, it is necessary to focus on the management of the mCNCP integrally, incorporating non-pharmacological therapies that provide the patients with skills to face the illness and, above all, empower themselves through information and training the self-care.
Researchers propose this clinical trial to demonstrate the effectiveness of a psychoeducational intervention focused on emotional coping in the control of symptoms, QoL and consumption of analgesics and health resources in patients with mCNCP. 2. RESEARCH QUESTION
The early and integratively detection and approach of mCNCP are the main tools to decrease its prevalence and negative effects on both the patient life and the Health System. Scientific evidence supports body-mind therapies and patient education in pain neuroscience that enable a positive adaptive response that appears to improve functionality and QoL in people affected by mCNCP. That is why the research question directed by this investigation is: "Can a psychoeducational intervention focused on emotional coping reduce the pain perception and improve the QoL of adult patients with mCNCP treated in Public Primary Health Centre of the Aljarafe-North Seville Area?" 3. OBJECTIVES:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After randomization and assignment to each arm, the masking will be triple ( researcher, evaluator of results, participant):
- Researchers: All the professionals who participate in the study will only do so in a single specific stage and will be blinded to the assignment and development of others.
- Evaluators of results: The results will be analyzed by an independent statistical professional and the evaluation of the response will be carried out by researchers who do not know the group to which each patient belongs.
- Participant: Patients will be blinded for up to six months of follow-up. Then they will know the group to which they belong and will be invited to do the workshop if they have belonged to the control group.
We don't believe that it is possible that a patient emergency unmasking will be required due to secondary effects, even so, the Patient Safety Committee will inform of any incident.
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
- •People over the age of
- •People with mCNCP served for this reason in the Primary Care Centres depend on Hospital San Juan de Dios del Aljarafe, who follow regular specific treatment on the WHO analgesic scale and who have accepted, after information and informed consent signature, their participation in this study.
- •Able to read and write Spanish.
排除标准
- •Patients who have received interventional analgesic treatment in the year for the current disease.
- •Have followed program or maintain out-of-hospital therapy similar to the one this study focuses on.
- •Have had surgery or been on a waiting list during the study.
- •Severe or decompensated systemic disease.
- •Active cancer disease.
- •Psychiatric pathology, epilepsy or cognitive impairment.
- •Abuse drug addiction.
- •Accidents or new Injuries that may increase the perception of pain during the study.
- •Labor litigation due to pain.
- •Language barrier.
- •LOSS CRITERIA:
- •Voluntary abandonment of the study.
- •Absence of one or more workshop sessions
- •Partial or complete loss of telephone follow-up.
- •Incomplete data collection.
- •Present any suspicious symptoms of COVID-19 disease collected by phone call the day before the workshop or communicate direct contact with a person infected in the previous days.
结局指标
主要结局
Change from Baseline Pain perception
时间窗: Baseline and six months.
It is measured by Verbal Numerical Rate Scale (NVRS). The NVRS will be used for its simplicity and reproducibility and in patients without cognitive impairment has a compliance close to 100%. Quantitative result by 0 to 10, where 0 is painless and 10 is as much pain as possible.
Change from Baseline Quality of life
时间窗: Baseline and six months.
It is measured by the EuroQol-5D questionnaire (EQ-5D). The EQ-5D is an instrument which evaluates the generic QoL with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit an index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). We have used this questionnaire because its analysis of internal consistency shows high Cronbach coefficients.
次要结局
- Gender.(Baseline.)
- Weight.(Baseline.)
- Height.(Baseline.)
- Rate of alcohol consumption.(Baseline.)
- Habitual residence.(Baseline.)
- Age.(Baseline.)
- Body Mass Index (BMI).(Baseline.)
- Pain evolution time.(Baseline.)
- Incidence of physical exercise practice.(Baseline.)
- % of patients with other concomitant chronic pathologies.(Baseline.)
- Marital status.(Baseline.)
- Changes from Baseline amount of analgesic pharmacological treatment at 6 months.(Baseline and six months.)
- % of patients with more than one type of pain in addition to mCNCP(Baseline.)
- Changes from Baseline Emotional Coping Strategies by the Reduced Chronic Pain Coping Questionnaire at 6 months.(Baseline and six months.)
- Educational level.(Baseline.)
- Incidence of caregivers among participants.(Baseline.)
- Changes in the frequentation of Medical Services during the study per patient.(Baseline, one, three and six months.)
- Changes from Baseline analgesic pharmacological treatment defined by the WHO therapeutic scale at 6 months.(Baseline and six months.)
- Rate of smoking consumption.(Baseline.)
- % of patients with family history of chronic pain.(Baseline.)
- Employment situation.(Baseline.)
- The rate of adherence to treatment.(Baseline, one, three and six months.)
- Incidence of causes of non-adherence to treatment.(Baseline, one, three and six months.)
- Changes from Baseline Sleep Quality (Oviedo Questionnaire) at 6 months.(Baseline and six months.)
- Changes from Baseline Global Family Unit Operation (Family Apgar Test) at 6 months(Baseline and six months.)