Clinical trial NCT05785455: Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain
Official title: Efficacy Of Pain Neuroscience Communication, Motivational Interviewing And Cognitive Exercise Therapy In Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Neck Pain
Keywords: Chronic pain
Pain neuroscience education
Exercise therapy
Neck pain
Motivational interviewing
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-03-27
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
Secondary outcomes:
measure: Change in Pain Severity
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Neck Disability
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Strait State Anxiety
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Chage in Pain Related Anxiety
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Catastrophizing
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Kinesiophobia
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Fear of Pain
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Depression
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Quality of Life
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Fatigue after deep neck flexors Test
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Cervical Range of Motion
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Pain Pressure Treshold
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Conditioned Pain Modulation
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Change in Central Sensitization
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
Other outcomes:
measure: Patient Satisfaction
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Drug Consumption
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Days of Sick Leave
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Adherence to treatment
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Assessment of adverse effects
timeFrame: Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention
measure: Therapeutic Alliance in Physiotherapy
timeFrame: After half of the treatment and after the treatment
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria de la Comunidad de Madrid
Study officials:
affiliation: Gerencia de Atención Primaria de la Comunidad de Madrid
name: María Adoración Prieto Aldana, 1st
role: PRINCIPAL_INVESTIGATOR
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