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NCT Number: NCT06749509

Effects of Musculoskeletal Rehabilitation Courses on Work Ability

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.

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Key information

Conditions

Musculoskeletal Diseases or Conditions Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Disorders Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Social Insurance Institution of Finland

Helsinki, 00250, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Groups 1 ja 2:

  • diagnosed musculoskeletal disorder
  • 18 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
  • 18 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

Exclusion criteria

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

Treatment and study plan

Face-to-face musculoskeletal rehabilitation

Other

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.

Musculoskeletal telerehabilitation

Other

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

Controls

Other

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.

Primary outcomes

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

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

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

Secondary outcomes

  1. Change from Baseline in Mood at 4-6 months

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

    Beck's Depression Inventory (BDI-21) (0-63; the higher score indicates more depressive symptoms)

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

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

    World Health Organization Quality of Life Instrument (WHOQOL-BREF) (0-100; the higher score indicates better quality of life)

  3. Change from Baseline in Functional Ability at 4-6 months

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

    PROMIS®-29 Profile v2.1 (without 4 questions concerning depression) (t-score; the higher score indicates more measured quality)

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

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

    5 questions from PROMIS®-29 Profile v2.1 concerning pain and 5 questions concerning musculoskeletal pain characteristics

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

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

    Return-to-Work Self Efficacy (RTW-SE), modified version (0-66; the higher score indicates better self efficacy)

  6. Invidual Goal Achievement

    Time frame: 4-6 months (after intervention)

    Goal Attainment Scaling method (GAS)

  7. Days Lost Through Sickness

    Time frame: Between January 1, 2024 and June 30, 2026

    Register-based data concerning sickness allowance. The sickness allowance is paid as compensation for loss of income due to incapacity for work lasting less than a full year. Periods which have lasted ten days or more are available in Kela's register.

Sponsors and collaborators

Lead sponsor

Social Insurance Institution, Finland

Other

Collaborators

  • Finnish Institute of Occupational Health

Registry information

Official study title

Effects of Musculoskeletal Rehabilitation Courses on Work Ability (Tules-kurssit Ja Työkyky)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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