Pain Education, Motivational Interviewing and Exercise in Chronic Neck Pain

NCT05785455 | Unknown

• 1 other identifier: PI21/01261
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Neck Pain

Keywords

Chronic pain; Pain neuroscience education; Exercise therapy; Neck pain; Motivational interviewing

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  The visual analog scale (VAS). This is a 100-mm line with "no pain" on the left side of the line and "worst pain imaginable" on the right side. The patient marks the intensity of her pain on a flat line, which allows observing the result obtained on the 100 mm line, being able to quantify her pain in this way. A score of less than 30 mm is considered mild pain, between 31 and 54 mm, moderate, and 55 mm, severe.

  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 (14)

• Change in Pain Severity

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Change in Neck Disability

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Change in Strait State Anxiety

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Chage in Pain Related Anxiety

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Change in Catastrophizing

  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 (6)

• Patient Satisfaction

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Drug Consumption

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

• Days of Sick Leave

  Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Subjects will receive a health education program during 5 group sessions of 60 minutes, taught by physical therapists without training in pain neuroscience education. All patients will receive 5 sessions, regardless of the group they belong to. Group education sessions will be in groups (of 5-6 patients), respecting the safety distance. Group sessions will be held in person, in small groups, at the health center, on a weekly basis. Both groups will receive online monitoring of the exercise program. An image with more information about the intervention and control is attached in Annex 2.

Other: Usual Care

COGMO Intervention

EXPERIMENTAL

Each subject will receive. a first individual session to assess their beliefs about pain and coping strategies, combining motivational interviewing and pain neuroscience education techniques, followed by 4 group sessions of 60 minutes, focused on the neurophysiology of pain and self-efficacy techniques in pain control, emphasizing . in two-way communication and followed by cognition targeted exercise therapy. These sessions will be taught by physiotherapists with specific training in motivational interviewing, pain neuroscience education and cognition targeted exercise

Other: COGMO Intervention

Interventions

COGMO Intervention OTHER

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

COGMO Intervention

Usual Care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Gerencia de Atención Primaria de la Comunidad de Madrid

Madrid, 28035, Spain

Location

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MeSH Terms

Conditions

Chronic Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María Adoración Prieto Aldana, 1st

  Gerencia de Atención Primaria de la Comunidad de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 14, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)