Keeping It Simple Study (KISS) - Pain Science Education for Patients With Chronic Musculoskeletal Pain Undergoing Community-based Rehabilitation: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Træningsenheden, Holbæk Municipality
RECRUITING
Holbæk
Træningsenheden, Køge Municipality
RECRUITING
Køge
Genoptræningscenteret, Solrød Municipality
RECRUITING
Solrød Strand
Contact Information
Primary
Bettina Eiger, PhD-student
bettinae@hst.aau.dk
+4522988906
Backup
Michael S. Rathleff, dr.med., PhD
mirs@hst.aau.dk
+4522117002
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
Active_comparator: Usual care
Usual Care: The control group receives unrestricted usual care. It could include a patient interview with individual goal setting and subsequent rehabilitation using cardio and strengthening exercises towards achieving the determined goals. It will be delivered by an authorized physiotherapist, and the intervention is determined by patient preferences, physiotherapist's clinical reasoning, and available resources.
Experimental: PNE4Adults - pain science education
PNE4Adults: In this group, the participants will receive an add-on individualized PSE in addition to the usual care with the PNE4Adults resource. The PNE4Adults session will follow the developed manual (http://www.paininmotion.be/pne4kids) and will be delivered by a physiotherapist in two sessions of each 30-45 minutes, shortly following the first meeting. Firstly, the function of a normal pain system is introduced, with examples of the pain being overly or under protective. Then, the patient teaches back giving the therapist the opportunity to evaluate the understanding and, if necessary, repeat essential key messages. Secondly, the sensitized pain system is explained. Thirdly, the subject is asked to reflect on this new information in relation to his/her own situation. Subsequently, the new knowledge is integrated in usual care with any additional measures that need to be included, e.g., graded exposure, stress relief, graded activity, and cognitive therapies.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern Denmark, Central Denmark Region, Aalborg University, Vrije Universiteit Brussel
Leads: Bettina Eiger

This content was sourced from clinicaltrials.gov