NCT05785455: COGMO

Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain

Status unknown NA Last updated 9 May 2023

What this trial tests

NA trial testing COGMO Intervention in Chronic Pain in 142 participants. Status unknown.

Timeline

1 April 2023

Primary endpoint
1 May 2024

14 May 2024

Quick facts

Lead sponsor	Gerencia de Atención Primaria, Madrid
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	142
Start date	1 April 2023
Primary completion	1 May 2024
Estimated completion	14 May 2024
Sites	1 location across Spain

Drugs / interventions tested

• COGMO Intervention
• Usual Care

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Neck Pain — all drugs for Neck Pain →

Sponsor

Gerencia de Atención Primaria, Madrid — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Pain or Neck Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of pain neuroscience education, motivational interviewing and cognition targeted exercise therapy in patients with chronic neck pain: protocol for a multicentre randomised controlled trial (the COGMO-AP study).
   Morales Tejera D, Nijs J, Malfliet A, Prieto Aldana MA, et al · · 2025 · cited 1× · PMID 39979041 · DOI 10.1136/bmjopen-2024-087788