Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain
Unknown statusNot applicableNCT05785455
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy Of Pain Neuroscience Communication, Motivational Interviewing And Cognitive Exercise Therapy In Patients With Chronic Neck Pain
- Conditions
- Interventions
- Other: COGMO Intervention
- Other: Usual Care
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Collaborators
- Instituto de Salud Carlos III
- Start date
- 2023-04-01
- Primary completion
- 2024-05-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05785455