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Recruiting NCT06297447

NCT06297447 Keeping it Simple Study (KISS)

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Clinical Trial Summary
NCT ID NCT06297447
Status Recruiting
Phase
Sponsor Bettina Eiger
Condition Musculoskeletal Pain
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2024-03-11
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
PNE4Adults - pain science educationUsual care

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2024-03-11 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas. Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens.

Eligibility Criteria

Inclusion Criteria: * Patients referred for rehabilitation in the municipalities Køge, Holbæk, and Solrød * With chronic (\>3 months) musculoskeletal pain. * Adult patients (≥18 years) - no upper limit * Able to understand, speak, and write Danish. Exclusion Criteria: * Known cognitive deficits (e.g., dementia). * Diagnosed with cancer or other serious pathologies, e.g., cauda equina. * Pregnancy * Drug addiction defined as the use of cannabis, opioids, or other drugs. * Neurologic or psychiatric diagnoses that hinder participation, e.g., stroke and borderline. * Lack of ability to cooperate.

Contact & Investigator

Central Contact

Bettina Eiger, PhD-student

✉ bettinae@hst.aau.dk

📞 +4522988906

Principal Investigator

Bettina Eiger, PhD-student

PRINCIPAL INVESTIGATOR

Aalborg University

Frequently Asked Questions

Who can join the NCT06297447 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Musculoskeletal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06297447 currently recruiting?

Yes, NCT06297447 is actively recruiting participants. Contact the research team at bettinae@hst.aau.dk for enrollment information.

Where is the NCT06297447 trial being conducted?

This trial is being conducted at Holbæk, Denmark, Køge, Denmark, Solrød Strand, Denmark.

Who is sponsoring the NCT06297447 clinical trial?

NCT06297447 is sponsored by Bettina Eiger. The principal investigator is Bettina Eiger, PhD-student at Aalborg University. The trial plans to enroll 200 participants.

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