Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06297447

Keeping It Simple Study (KISS) - Evaluating Pain Science Education for Adults with Chronic Musculoskeletal Pain in Community Rehabilitation

Led by Bettina Eiger · Updated on 2024-12-27

200

Participants Needed

3

Research Sites

142 weeks

Total Duration

On this page

Sponsors

B

Bettina Eiger

Lead Sponsor

U

University of Southern Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effect of a pain neuroscience education program called PNE4Adults on adults living with chronic musculoskeletal pain lasting more than three months. Chronic musculoskeletal pain affects a large portion of the population worldwide and leads to high healthcare costs, reduced work ability, and decreased quality of life. The study aims to see if adding pain education to usual care can improve patients' understanding and management of their pain, which may help break cycles that maintain chronic pain and improve rehabilitation outcomes. The study compares two groups: one receiving usual care alone and the other receiving usual care plus the PNE4Adults pain science education program. This program includes a therapist manual and a board game designed to engage patients and help them understand complex pain mechanisms, especially those with lower health literacy. The program is delivered in community-based rehabilitation settings across several municipalities. The trial is a multicenter randomized controlled study without a specified study phase. Participants will be assessed using the Musculoskeletal Health Questionnaire at 3 months, with additional evaluations at 6 weeks and 6 months. Researchers will collect data through patient questionnaires, interviews, and observations to understand how the education program works and for whom. The study also monitors safety and adherence during the rehabilitation period. Total participation length depends on follow-up assessments occurring up to 6 months after starting treatment.

CONDITIONS

Official Title

Keeping it Simple Study (KISS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for rehabilitation in the municipalities Køge, Holbæk, and Solrød
  • Chronic musculoskeletal pain lasting more than 3 months
  • Adults aged 18 years and older
  • Able to understand, speak, and write Danish
Not Eligible

You will not qualify if you...

  • Known cognitive deficits such as dementia
  • Diagnosed with cancer or other serious conditions like cauda equina syndrome
  • Pregnant women
  • Drug addiction including cannabis, opioids, or other drugs
  • Neurological or psychiatric diagnoses that hinder participation, such as stroke or borderline personality disorder
  • Unable to cooperate

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Trial Site Locations

Total: 3 locations

1

Træningsenheden, Holbæk Municipality

Holbæk, Region Sjælland, Denmark, 4300

Actively Recruiting

2

Træningsenheden, Køge Municipality

Køge, Region Sjælland, Denmark, 4600

Actively Recruiting

3

Genoptræningscenteret, Solrød Municipality

Solrød Strand, Region Sjælland, Denmark, 2680

Actively Recruiting

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Research Team

B

Bettina Eiger, PhD-student

M

Michael S. Rathleff, dr.med., PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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