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
Conceptual hypothesis: In patients with chronic neck pain, a complex multicomponent intervention (based on pain neuroscience education, motivational interviewing and cognitive exercise therapy: "COGMO intervention") performed by primary care physical therapists will increase. the proportion of patients with clinical improvement in pain intensity, compared with a standard exercise health education programme.
Operative hypothesis: In patients with chronic neck pain, a complex "COGMO" intervention will achieve an absolute difference in the percentage of patients who achieve a clinical improvement in pain intensity (at least 30mm in the long-term VAS: 12 months), which will be at least 25% more, in the intervention group compared to the group control.
Objectives
Main goal
Evaluate the effectiveness of a complex intervention "COGMO Intervention" based on education in neuroscience of pain, motivational interviewing and cognitive exercise therapy compared with practice routine clinical practice in physiotherapy (health education with exercises), to improve the intensity of pain, in patients wit Chronic Neck Pain at 12 months of follow-up.
Secondary Objectives
To evaluate the effectiveness of the COGMO intervention against usual therapy with health education at 3, 6 and 12 months to improve: o Pain: intensity, severity, total and distal mechanical hyperalgesia, pain conditioned modulation, changes in pain-free joint range of motion (ROM) and motor control. o Psychosocial aspects: depressive symptoms, anxiety, kinesophobia, catastrophism, fear of pain. o Patient-reported outcomes (PROMS): health-related quality of life. To describe the adherence to the COGMO intervention and the degree of satisfaction of the patients with the therapy received in both groups.
Methodology
Design: Pragmatic randomized cluster clinical trial with 12-month follow-up. The unit of randomization is the physiotherapy professional and the unit of analysis is the patient.
Population: Patients with chronic neck pain under follow-up in Primary Care Centers (PCC).
Scope: 14 PCC of the Community of Madrid (Arroyo de la Vega, Valdelasfuentes, Colmenar Viejo Sur, Dr. Castroviejo, Ciudades, Isabel II, Barrio del Pilar, Colmenar de Oreja, La Cabrera, Mirasierra, Ibiza, Miraflores, Espronceda and Los Yébenes.
Sample size: According to two systematic reviews, chronic neck pain with manual physiotherapy treatment improves by 11% compared to 29% in the control group. Expecting to find a difference in percentages of patients who achieve a clinically significant decrease in pain (at least 30 mm on the visual scale), of 25% more patients in the COGMO intervention group than in the control group, for a level of confidence 95% and 80% power, 58 subjects would be needed in each group. Considering that the average size of the cluster of patients per physiotherapist is 6 patients, and for an intercalate correlation coefficient of 0.02, the design effect will be. of 1.1 \[(DE=1+(6-1)\*0.02=1.1, (58+58)\*DE(1.1)\] the necessary sample size would be 128 patients, overestimating due to possible losses of 10%, the final size is 142 patients (71 per branch).
Sampling: consecutive of the patients included in the waiting list of patients referred to the Unit of Physiotherapy in each health center.
Recruitment: Of professionals: the research team already has an associated clinical group of at least 29 physiotherapists. Patients: They will be selected from the list of patients (provided by the health service) who meet the inclusion criteria for each professional's quota. Subsequently, each physiotherapist offer. Consecutively, the participation of patients from the received list, until completing a number of 5-6 per physiotherapist. When the patient agrees to participate, the physiotherapist will inform. in detail about the study, confirm. inclusion/exclusion criteria and patient acceptance with the signing of the informed consent. If the patient does not accept, data on age, sex and reason for refusal will be collected.
The patient recruitment period is estimated at one year and the follow-up of each patient lasts 12 months. from the end of the COGMO or EPS intervention.
Randomization: The randomization unit is the physical therapists who will participate in the study and the analysis are the patients. It will be done. using the module for assigning subjects to treatment of the program Epidat 4.1, considering as treatment the intervention to study COGMO and as control the project of EPS exercises. To obtain the same number of professionals in each group (intervention and control) it will be used. the option of balanced groups. Once the physiotherapist has been assigned to a study group, all patients recruited by him/her will be included in that group. The assignment will be. carried out centrally by the Research Support Unit of the AP Madrid Healthcare Management. It will be done. after each physiotherapist has included and made the selection of patients and the external evaluators have collected the variables of the baseline visit. Subsequently, each MF will receive. the information of the study group to which it has been assigned.
Physiotherapists assigned to the intervention group will receive training in the intervention and those in the control group will access the project. At the end of the trial, interested physiotherapists in the control group will be able to receive training in the COGMO intervention.
Blinding: Due to the characteristics of the study, it is not possible to blind patients or physiotherapists. who will deliver the COGMO intervention or control. The assessors of the outcome variables will be blinded. In addition, at the end of each evaluation they will be examined. the success of blinding the assessor by asking him to indicate the participant group assignment, including percent certainty (50% certainty equals pure guess).
The people in charge of the analysis of results will be blinded to the group assignment.
