Musculoskeletal Diseases or ConditionsNCT06749509
Effects of Musculoskeletal Rehabilitation Courses on Work Ability
An observational study of Musculoskeletal Diseases or Conditions and Musculoskeletal Disorders, run by Social Insurance Institution, Finland at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases or Conditions, Musculoskeletal Disorders
- What is being tested?
- Face-to-face musculoskeletal rehabilitation and Musculoskeletal telerehabilitation
- Type of treatment
- Pill or oral medicine
- How many people
- 480 participants
- Where
- 1 siteFinland
- Study dates
- 13 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Musculoskeletal Rehabilitation Courses on Work Ability (Tules-kurssit Ja Työkyky)
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?
Read more
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.
- Being tested
- Face-to-face musculoskeletal rehabilitation, Musculoskeletal telerehabilitation, Controls
- Keywords
- Musculoskeletal Diseases, Musculoskeletal Disorders, Work Ability, Rehabilitation, Telerehabilitation, Quality of Life, Pain, Chronic Pain, Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Diseases, Pain, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face musculoskeletal rehabilitationOther
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 telerehabilitationOther
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
ControlsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Face-to-face musculoskeletal rehabilitation | |
| Musculoskeletal telerehabilitation (B) | Participation in a telerehabilitation course organized by Kela for those with MSD (B) Receives: 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 Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Beck's Depression Inventory (BDI-21) (0-63; the higher score indicates more depressive symptoms)
Measured: Baseline (pre-intervention), 4-6 months (after the intervention)
Change from Baseline in Quality of Life at 4-6 months
World Health Organization Quality of Life Instrument (WHOQOL-BREF) (0-100; the higher score indicates better quality of life)
Measured: Baseline (pre-intervention), 4-6 months (after the intervention)
Change from Baseline in Functional Ability at 4-6 months
PROMIS®-29 Profile v2.1 (without 4 questions concerning depression) (t-score; the higher score indicates more measured quality)
Measured: Baseline (pre-intervention), 4-6 months (after the intervention)
Change from Baseline in Pain at 4-6 months and 8-10 months
5 questions from PROMIS®-29 Profile v2.1 concerning pain and 5 questions concerning musculoskeletal pain characteristics
Measured: 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
Return-to-Work Self Efficacy (RTW-SE), modified version (0-66; the higher score indicates better self efficacy)
Measured: Baseline (pre-intervention), 4-6 months (after the intervention)
Invidual Goal Achievement
Goal Attainment Scaling method (GAS)
Measured: 4-6 months (after intervention)
Days Lost Through Sickness
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.
Measured: Between January 1, 2024 and June 30, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start13 Jan 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Social Insurance Institution, Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute of Occupational Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749509
- Sponsor's protocol ID
- KELA_4822_2024
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Musculoskeletal Rehabilitation Courses on Work Ability (Tules-kurssit Ja Työkyky)
- ClinicalTrials.gov ID
- NCT06749509
- Acronym / sponsor ID
- KELA_4822_2024
- Keywords
- Musculoskeletal Diseases, Musculoskeletal Disorders, Work Ability, Rehabilitation, Telerehabilitation, Quality of Life, Pain, Chronic Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Social Insurance Institution, FinlandUniversity, hospital or other
- Collaborators
- Finnish Institute of Occupational Health
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face musculoskeletal rehabilitation (A) | – | Other: Face-to-face musculoskeletal rehabilitationParticipation in a face-to-face rehabilitation course organized by the Social Insurance Institution of Finland (Kela) for those with musculoskeletal disorders (MSD) (A) |
| Musculoskeletal telerehabilitation (B) | – | Other: Musculoskeletal telerehabilitationParticipation in a telerehabilitation course organized by Kela for those with MSD (B) |
| Controls (C) | – | Other: ControlsPersons 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- diagnosed musculoskeletal disorder
- 18 years or older
- in employment, returning to work, studying, or receives rehabilitation subsidy
- participating in either of the following:
- willingness to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face musculoskeletal rehabilitationKela'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. | Other | Face-to-face musculoskeletal rehabilitation (A) |
| Musculoskeletal telerehabilitationKela´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 | Other | Musculoskeletal telerehabilitation (B) |
| ControlsThe 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. | Other | Controls (C) |
Primary outcome
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)
7 secondary outcomes
Change from Baseline in Mood at 4-6 months
Time frame: Baseline (pre-intervention), 4-6 months (after the intervention)
Change from Baseline in Quality of Life at 4-6 months
Time frame: Baseline (pre-intervention), 4-6 months (after the intervention)
Change from Baseline in Functional Ability at 4-6 months
Time frame: Baseline (pre-intervention), 4-6 months (after the intervention)
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)
Change from Baseline in Return-to-Work Self Efficacy at 4-6 months
Time frame: Baseline (pre-intervention), 4-6 months (after the intervention)
Invidual Goal Achievement
Time frame: 4-6 months (after intervention)
Days Lost Through Sickness
Time frame: Between January 1, 2024 and June 30, 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases or Conditions and Musculoskeletal Disorders, run by Social Insurance Institution, Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.