Keeping it Simple Study (KISS)

NCT06297447 | Recruiting DMC

• 1 other identifier: N-20230073
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Musculoskeletal Pain; Chronic Pain

Keywords

Pain education; Musculoskeletal Pain; Chronic pain; PNE4Adults; Adults; Rehabilitation; Health literacy

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal Health Questionnaire (MSK-HQ)

  Musculoskeletal (MSK) Health assessed by the Musculoskeletal Health Questionnaire. Score from 0 to 56. Higher scores reflect better MSK health, and better outcome

  Primary endpoint at 3 months, additional at 6 weeks and 6 months

Secondary Outcomes (10)

• Mean Pain intensity

  At 6 weeks, 3 months and 6 months

• Pain interference

  At 6 weeks, 3 months and 6 months

• Concept of pain

  At 6 weeks, 3 months and 6 months

• Pain catastrophizing

  At 6 weeks, 3 months and 6 months

• Fear of movement

  At 6 weeks, 3 months and 6 months

Study Arms (2)

"Usual care"

ACTIVE COMPARATOR

"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.

Other: Usual care

PNE4Adults - pain science education

EXPERIMENTAL

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.

Other: PNE4Adults - pain science education

Interventions

PNE4Adults - pain science education OTHER

Is formerly described under arm descriptions

PNE4Adults - pain science education

Usual care OTHER

Is formerly described under arm descriptions

"Usual care"

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bettina Eiger: lead
• University of Southern Denmark: collaborator
• Aalborg University: collaborator
• Central Denmark Region: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (3)

Træningsenheden, Holbæk Municipality

Holbæk, Region Sjælland, 4300, Denmark

RECRUITING

Træningsenheden, Køge Municipality

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Genoptræningscenteret, Solrød Municipality

Solrød Strand, Region Sjælland, 2680, Denmark

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bettina Eiger, PhD-student

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina Eiger, PhD-student

CONTACT

+4522988906; bettinae@hst.aau.dk

Michael S. Rathleff, dr.med., PhD

CONTACT

+4522117002; mirs@hst.aau.dk

Study Design

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

Model Details: Multicenter randomized controlled, superiority trial with a 2-group parallel design.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: March 11, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

DK (3)