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Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain

NCT05785455 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

COGMO Intervention

Group sessions in which each patient, after motivational interviewing sessions will follow a goup education in pain neuroscince program followed by a cognition targeted exercise therapy

OTHER

Usual Care

Usual Primary Care health education and treatment for patients with chronic neck pain

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Gerencia de Atención Primaria, Madrid

    lead OTHER_GOV

Principal Investigators

  • María Adoración Prieto Aldana, 1st · Gerencia de Atención Primaria de la Comunidad de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-05-01
Completion
2024-05-14

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785455 on ClinicalTrials.gov