Efficacy Of Pain Neuroscience Communication, Motivational Interviewing And Cognitive Exercise Therapy In Patients With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
Objectives: To evaluate the effectiveness of a complex intervention (COGMO intervention) compared with routine clinical practice in primary care physiotherapy to improve the intensity, severity of pain, and cervical disability in patients with chronic neck pain.
Methodology: Design: Pragmatic cluster randomized trial with 12-month follow-up. The unit of randomization is the physiotherapist and the unit of analysis the patient.
Scope: Madrid Primary Care health centers. Subjects: Patients 18-65 years old, with neck pain (> 3 months), moderate-severe (>30 mm in visual pain scale). Sample size: 142 patients (71 per branch).
Sampling: consecutive of patients who are referred from the family doctor to the Primary Care physiotherapist. Intervention: COGMO Intervention Group (3 components: pain neuroscience communication, motivational interviewing and cognition targeted exercise therapy). Control group: Health education program. Variables: Main: Decrease in intensity of pain: yes / no (> = 30mm on the visual pain scale). Secondary: Related to pain (severity of pain, modulation conditioned to pain, temporal summation, decrease in the disability index, related to psycho-emotional-social aspects: decrease in fear / avoidance behaviour, decrease in kinesiophobia (TSK) and Catastrophism (PCS). Quality of life (Euroqol). Sociodemographic, other treatments, adherence to intervention. Data collection: Baseline visit and 3 follow-up visits (3,6,12 months).
Statistical analysis: Intention-to-treat analysis. Difference in the percentage of subjects who achieve success in the main variable at 12 months in the COGMO group compared to control group. A GEE logit model to adjust for other factors.
详细描述
Data management
Typology, format and ownership of data: The data to be collected are individual patient variables that will be collected after inclusion in the study and signing of the informed consent. The variables have been detailed in the methodology section and in Annex 1 (questionnaires). The information will be collected through a clinical interview and complementary examination tests.
Repository and data access procedures. Security: The information collected will be incorporated by the researchers into an electronic data collection notebook (CRDe), which will assign a unique code to each patient, and in which there will be no reference to the identity of the subjects. Each researcher will keep the list of their included patients, with the link between code and affiliation on a secure site. Access to the CRDe will be done with a user ID and password, and it will be hosted on the research/innovation server of the Primary Care Assistance Management/ Primary Care Biosanitary Research and Innovation Foundation (FIIBAP) in Madrid. The results will be disseminated in scientific forums, congresses, scientific publications and in social media, maintaining the confidentiality and rights of the participants. In no case will data that allows them to be identified be published. In order to maximize access and reuse of scientific data generated by the project, the results and the anonymized database will be published openly, always within the framework of legal regulations.
Ethical and legal aspects: The trial will respect the basic ethical principles of autonomy, beneficence, justice and non-maleficence and will follow the standards of Good Clinical Practice and the principles set forth in the latest declaration of Helsinki and the Oviedo Convention (1997). ). Study subjects will be fully informed of the study, and will only be included if they provide written informed consent, clearly detailing post-hoc data use. With regard to the treatment, communication and transfer of data, it will be done in accordance with the provisions of the RGPD (EU Regulation) 2016/679 of the European Parliament and of the Council, of April 27, 2016 and the LOPDGDD 3/2018, of December 5th.
Hypothesis
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
- Double (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
- •Age between 18 and 65 years.
- •Diagnosed with chronic neck pain, according to the death of the IASP (International Association for the Study of Pain) with duration of pain greater than 3 months and referred to Physiotherapy by their Family doctor.
- •Score on the Neck Disability Index (IDC) questionnaire equal to or greater than 20% (10/50).
- •Pain intensity at the moment in the cervical region equal to or greater than 30mm on the visual analog scale.
- •Sign informed consent
排除标准
- •Neuropathies and/or radiculopathies, other pathologies or comorbidities that may contraindicate the therapies to be applied, severe depression, rheumatic, inflammatory diseases, cancer, suspected fibromyalgia, systemic diseases, serious psychological disorders, neck pain secondary to an accident of traffic.
- •Criteria for referral to surgery or failed spinal surgery.
- •Inability to read, understand and complete questionnaires; o understand and follow verbal commands.
- •Have received physical therapy in the last 3 months.
- •Have any pending legal action (for example: compensation for injury).
结局指标
主要结局
Change in Pain Intensity
时间窗: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
The visual analog scale (VAS). This is a 100-mm line with "no pain" on the left side of the line and "worst pain imaginable" on the right side. The patient marks the intensity of her pain on a flat line, which allows observing the result obtained on the 100 mm line, being able to quantify her pain in this way. A score of less than 30 mm is considered mild pain, between 31 and 54 mm, moderate, and 55 mm, severe.
次要结局
- Change in Catastrophizing(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Pain Severity(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Neck Disability(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Strait State Anxiety(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Chage in Pain Related Anxiety(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Kinesiophobia(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Quality of Life(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Fear of Pain(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Depression(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Cervical Range of Motion(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Fatigue after deep neck flexors Test(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Conditioned Pain Modulation(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Pain Pressure Treshold(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)
- Change in Central Sensitization(Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention)