Keeping it Simple Study (KISS)

Sponsor
Bettina Eiger
Study ID
NCT06297447
Status
Recruiting
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Conditions

  • Chronic Pain
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PNE4Adults - pain science education — OTHER
    Is formerly described under arm descriptions
  • Usual care — OTHER
    Is formerly described under arm descriptions

Study Details

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.

Key Dates

First listed
Mar 7, 2024
Start date
Mar 11, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Musculoskeletal Health Questionnaire (MSK-HQ) [ Time Frame: Primary endpoint at 3 months, additional at 6 weeks and 6 months ]

Central Contacts

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