protocolSection identificationModule nctId: NCT06297447, orgStudyIdInfo id: N-20230073, briefTitle: Keeping it Simple Study (KISS), acronym: KISS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Bettina Eiger, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: Aalborg University, collaborators name: Central Denmark Region, collaborators name: Vrije Universiteit Brussel, descriptionModule briefSummary: 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., conditionsModule conditions: Musculoskeletal Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter randomized controlled, superiority trial with a 2-group parallel design., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Randomization will be stratified by cite. Block randomization in random concealed block sizes of 4 to 6 (1:1) into two parallel groups is used to avoid imbalance in the randomization between intervention groups. A person not otherwise affiliated with the study will generate the randomization sequence.The randomization will be coded (Group 1 or 2), thus the primary investigator (BE) will not know the code to the groups., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: PNE4Adults - pain science education, interventions name: Usual care, outcomesModule primaryOutcomes measure: Musculoskeletal Health Questionnaire (MSK-HQ), secondaryOutcomes measure: Mean Pain intensity, secondaryOutcomes measure: Pain interference, secondaryOutcomes measure: Concept of pain, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Fear of movement, secondaryOutcomes measure: Patient specific functional limitation, secondaryOutcomes measure: Patient impression of change, secondaryOutcomes measure: Patient satisfaction with current symptom state, secondaryOutcomes measure: Pain Self-efficacy, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Træningsenheden, Holbæk Municipality, status: RECRUITING, city: Holbæk, state: Region Sjælland, zip: 4300, country: Denmark, contacts name: Helle B. Hansen, PT, role: CONTACT, phone: 72363252, email: helha@holb.dk, geoPoint lat: 55.71354, lon: 11.7169, locations facility: Træningsenheden, Køge Municipality, status: RECRUITING, city: Køge, state: Region Sjælland, zip: 4600, country: Denmark, contacts name: Annette B. Schlaikjer, PT, role: CONTACT, phone: +45 51 36 33 78, email: annette.schlaikjer@koege.dk, geoPoint lat: 55.45802, lon: 12.18214, locations facility: Genoptræningscenteret, Solrød Municipality, status: RECRUITING, city: Solrød Strand, state: Region Sjælland, zip: 2680, country: Denmark, contacts name: Linda M. Blæsbjerg, PT, role: CONTACT, phone: +4556182405, email: kolbl@solrod.dk, geoPoint lat: 55.53285, lon: 12.22227, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-06, uploadDate: 2024-03-06T10:23, filename: Prot_000.pdf, size: 413728, hasResults: False