NCT06749509

Brief Summary

The goal of this observational study is to learn about the effects of two different musculoskeletal rehabilitation programs in working-age people with musculoskeletal disorders. The main question it aims to answer is: Do musculoskeletal rehabilitation programs A or B improve work ability in people with musculoskeletal disorders? Participants starting in rehabilitation programs A and B will answer survey questions about their work ability and related factors three times: when starting, immediately after the rehabilitation ends, and 4 months after ending the rehabilitation. Participants in study group C will answer the same questions during the same time period. Researchers will compare participants in rehabilitation programs A and B to participants in group C, who have musculoskeletal disorders but will not participate in rehabilitation programs. The comparison is done to see if there are differences in the changes in work ability and related factors, such as pain or quality of life.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

December 19, 2024

Last Update Submit

February 10, 2025

Conditions

Keywords

Musculoskeletal DiseasesMusculoskeletal DisordersWork AbilityRehabilitationTelerehabilitationQuality of LifePainChronic PainMusculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Work Ability at 4-6 Months and 8-10 Months

    Work Ability Index questionnaire (7-49 points; the higher score indicates better work ability)

    Baseline (pre-intervention), 4-6 months (after the intervention), 8-10 months (4-month follow-up)

Secondary Outcomes (7)

  • Change from Baseline in Mood at 4-6 months

    Baseline (pre-intervention), 4-6 months (after the intervention)

  • Change from Baseline in Quality of Life at 4-6 months

    Baseline (pre-intervention), 4-6 months (after the intervention)

  • Change from Baseline in Functional Ability at 4-6 months

    Baseline (pre-intervention), 4-6 months (after the intervention)

  • Change from Baseline in Pain at 4-6 months and 8-10 months

    Baseline (pre-intervention), 4-6 months (after the intervention), 8-10 months (4-month follow-up)

  • Change from Baseline in Return-to-Work Self Efficacy at 4-6 months

    Baseline (pre-intervention), 4-6 months (after the intervention)

  • +2 more secondary outcomes

Study Arms (3)

Face-to-face musculoskeletal rehabilitation (A)

Participation in a face-to-face rehabilitation course organized by the Social Insurance Institution of Finland (Kela) for those with musculoskeletal disorders (MSD) (A)

Other: Face-to-face musculoskeletal rehabilitation

Musculoskeletal telerehabilitation (B)

Participation in a telerehabilitation course organized by Kela for those with MSD (B)

Other: Musculoskeletal telerehabilitation

Controls (C)

Persons with MSD who had contacted their occupational health care because of musculoskeletal symptoms, and will not participate in Kela's musculoskeletal rehabilitation course during the study period

Other: Controls

Interventions

Kela's rehabilitation course for those with MSD includes two 5-day periods and one 3-day period of face-to-face rehabilitation, which are carried out in a Finnish rehabilitation center over a 9-month period and implemented by a multidisciplinary team of rehabilitation experts. The rehabilitation course is group-based and provided free of charge. The 9-month rehabilitation period also includes calls to the participants before and after rehabilitation. The course is intended for persons over the age of 18 with diagnosed MSD and difficulties coping with work or studies. The course provides support, tools, and coaching to help manage daily life and work with MSD. Self-rehabilitation is an important component of the program. Individual goals based on the GAS method are set, evaluated, and adjusted during the rehabilitation. A medical statement is required when applying for the rehabilitation course.

Face-to-face musculoskeletal rehabilitation (A)

Kela´s MSD telerehabilitation course is arranged entirely as telerehabilitation, and it includes videoconferencing, online rehabilitation, and group-based rehabilitation days implemented by a multidisciplinary team of rehabilitation experts. Participation does not require particular IT skills, but appropriate equipment (e.g., mobile phone, laptop, tablet computer) is needed. The rehabilitation course is free of charge, and the total duration, including the calls before and after rehabilitation, is approximately 7 months. The course is intended for persons over the age of 18 with diagnosed MSD and difficulties coping with work or studies. The course provides support, tools, and coaching to help manage daily life and work with MSD. Self-rehabilitation is an important component of the program. Individual goals based on the GAS method are set, evaluated, and adjusted during the rehabilitation. A physiotherapist's recommendation is required when applying for the telerehabilitation course

Musculoskeletal telerehabilitation (B)

The control participants have an MSD diagnosis and musculoskeletal symptoms. Based on an occupational physiotherapist's brief evaluation they are eligible to apply for Kela's musculoskeletal rehabilitation (the interventions below). By them own choice, however, they will not participate in these rehabilitation programs in the near future. The controls are recruited via two occupational health care producers in the private sector.

Controls (C)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those starting in either of the following services between January 2025 and January 2026: * Kela's face-to-face musculoskeletal rehabilitation (A) * Kela's musculoskeletal telerehabilitation (B). Persons with MSD who contacted their occupational health care between January 2025 and January 2026 because of musculoskeletal symptoms, but will not participate in Kela's musculoskeletal rehabilitation. Two private companies offering occupational health care services nationally are involved.

You may qualify if:

  • Groups 1 ja 2:
  • diagnosed musculoskeletal disorder
  • years or older
  • in employment, returning to work, studying, or receives rehabilitation subsidy
  • participating in either of the following:
  • Kela's face-to-face musculoskeletal rehabilitation (A)
  • Kela's musculoskeletal telerehabilitation (B)
  • willingness to participate in the study
  • Group 3 (Controls):
  • diagnosed musculoskeletal disorder
  • years or older
  • in employment, returning to work, studying, or receives rehabilitation subsidy
  • musculoskeletal symptoms have lasted at least 3 months and the person has participated in physiotherapy or self-rehabilitation without satisfactory results
  • willingness to participate in the study

You may not qualify if:

  • Group 3 (Controls):
  • Current rehabilitation needs are related to post-treatment care or post-discharge rehabilitation.
  • acute or untreated substance use disorder
  • participating in or apply for Kela's musculoskeletal rehabilitation services (A or B) during the next few months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Social Insurance Institution of Finland

Helsinki, 00250, Finland

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesPainChronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

January 13, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations