Long Term Musculoskeletal PainNCT06600685
Functionally Oriented Music Therapy (FMT) In The Treatment Of Long Term Pain
A study testing Functionally oriented music therapy (FMT) in people with Long Term Musculoskeletal Pain, run by Mälardalen University at 1 site in Sweden.
Trial summary
Project idea: This project aims to explore and evaluate a hitherto unexplored treatment method for people living with long-term musculoskeletal pain. The project's starting point is that it is urgent to develop evidence-based methods that can promote health and well-being, alleviate suffering and lead to an improved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Musculoskeletal Pain
- What is being tested?
- Functionally oriented music therapy (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- People with long-term musculoskeletal pain that occurred for at least three months.
- People over 18 years of age.
- People able to understand and speak Swedish or English
Who cannot join
- Severe hearing loss
- Visual impairment
- Cognitive impairment.
- Pain conditions caused by:
- malignancy
- severe spinal pathology or
- neurological disease that severely limit the ability to perform activities.
Trial locations and contacts
1 site in 1 country.
About this study
Project idea: This project aims to explore and evaluate a hitherto unexplored treatment method for people living with long-term musculoskeletal pain. The project's starting point is that it is urgent to develop evidence-based methods that can promote health and well-being, alleviate suffering and lead to an improved quality of life in the target group. The method "Functionally oriented music therapy" (FMT), to be studied in the present project, can be such a method. In FMT, music and movement are combined for health-promoting purposes, which can be assumed to lead to experiences of well- being and recovery. The method is already used in primary care in Region Sörmland, but the method is not evidence-based in the treatment of long-term musculoskeletal pain, which is why scientific evaluation is needed. The project is urgent both from a societal and patient perspective, among other things because healthcare resources need to be used more efficiently than today. To evaluate the method, both qualitative and quantitative research methodology will be used. If the results of the project are positive, i.e., if we can find evidence that various aspects of health are specifically affected/improved, then the results can contribute to evidence based FMT support for health promotion purposes for people with long-term musculoskeletal pain. If, on the other hand, the results show that FMT has no or only little effect, that in itself is an important contribution to new knowledge about treatment and recovery in people with long-term musculoskeletal pain. Today, FMT is used in, among other things, habilitation, rehabilitation and psychiatric care. However, research is needed that deals with the method's health-promoting efforts even in the case of long-term musculoskeletal pain problems.
- Conditions
- Long Term Musculoskeletal Pain
- Being tested
- Functionally oriented music therapy (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionally oriented music therapy (FMT)Other
There are different methods of music therapy and one of these is FMT. It is a body-based and music therapeutic treatment method that is used for health-promoting purposes. With the help of i.e. drums, cymbals, various custom-made drumsticks, flutes, chairs, balance balls and balance cushions. FMT strives to support, strengthen and develop the person's physical, mental and social abilities. FMT-sessions (20 minuets/1 time a week) are performed individuelly (a patient with a educated music therapist).
| Study group | Role | What they receive |
|---|---|---|
| FMT arm | Other | Not described Receives: Other: Functionally oriented music therapy (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life
Support, strengthen and develop the person's physical, mental and social abilities. Questionnaires concerning; body awareness, pain level, management of pain and fear of movement, pain-related activity limitations, emotions, depressive symptoms and anxiety, self-reported sick-leave and general perceived health will be used. The questionnaires are validated and psychometrically evaluated. Self-estimation (using different Lickert-scales).
The results of phase 1 can contribute to the addition of more outcome measures in phase 2.
Measured: Assessed every 2 weeks for 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Musculoskeletal PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1.) Single case research experimental design. N=10 participants will be asked to answer a set of questionnaires (Lickert-scales) every week for three weeks before the start of the treatment period and after completing FMT sessions 2, 4, 6, 8, and 10. This is to capture results based on patients' self-assessments during entire FMT treatment. Three measurement sessions will be completed before treatment begins to capture the baseline of their condition and pain in their daily life. Participants will begin their measurements on different weeks, to reduce the risk that the baseline measurement is due to any external factors that may affect participants if they are measured during the same time period/week. Phase 2.) Pilot study with a mixed design. Relevant outcome measures (from phase 1) will be used to achieve valid and reliable results. N=60 participants will be recruited to participate in FMT treatment during a period of ten weeks.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600685
- Sponsor's protocol ID
- 2024-04082-01
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functionally Oriented Music Therapy (FMT) In The Treatment Of Long Term Pain
- ClinicalTrials.gov ID
- NCT06600685
- Acronym / sponsor ID
- 2024-04082-01
- Conditions
- Long Term Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 19 Sep 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.
Project idea: This project aims to explore and evaluate a hitherto unexplored treatment method for people living with long-term musculoskeletal pain. The project's starting point is that it is urgent to develop evidence-based methods that can promote health and well-being, alleviate suffering and lead to an improved quality of life in the target group. The method "Functionally oriented music therapy" (FMT), to be studied in the present project, can be such a method. In FMT, music and movement are combined for health-promoting purposes, which can be assumed to lead to experiences of well- being and recovery. The method is already used in primary care in Region Sörmland, but the method is not evidence-based in the treatment of long-term musculoskeletal pain, which is why scientific evaluation is needed. The project is urgent both from a societal and patient perspective, among other things because healthcare resources need to be used more efficiently than today. To evaluate the method, both qualitative and quantitative research methodology will be used. If the results of the project are positive, i.e., if we can find evidence that various aspects of health are specifically affected/improved, then the results can contribute to evidence based FMT support for health promotion purposes for people with long-term musculoskeletal pain. If, on the other hand, the results show that FMT has no or only little effect, that in itself is an important contribution to new knowledge about treatment and recovery in people with long-term musculoskeletal pain. Today, FMT is used in, among other things, habilitation, rehabilitation and psychiatric care. However, research is needed that deals with the method's health-promoting efforts even in the case of long-term musculoskeletal pain problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1.) Single case research experimental design. N=10 participants will be asked to answer a set of questionnaires (Lickert-scales) every week for three weeks before the start of the treatment period and after completing FMT sessions 2, 4, 6, 8, and 10. This is to capture results based on patients' self-assessments during entire FMT treatment. Three measurement sessions will be completed before treatment begins to capture the baseline of their condition and pain in their daily life. Participants will begin their measurements on different weeks, to reduce the risk that the baseline measurement is due to any external factors that may affect participants if they are measured during the same time period/week. Phase 2.) Pilot study with a mixed design. Relevant outcome measures (from phase 1) will be used to achieve valid and reliable results. N=60 participants will be recruited to participate in FMT treatment during a period of ten weeks.
| Arm | Type | Receives |
|---|---|---|
| FMT arm | Other | Other: Functionally oriented music therapy (FMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People with long-term musculoskeletal pain that occurred for at least three months.
- People over 18 years of age.
- People able to understand and speak Swedish or English
Key exclusion criteria (7 listed)
- Severe hearing loss
- Visual impairment
- Cognitive impairment.
- malignancy
- severe spinal pathology or
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 |
|---|---|---|
| Functionally oriented music therapy (FMT)There are different methods of music therapy and one of these is FMT. It is a body-based and music therapeutic treatment method that is used for health-promoting purposes. With the help of i.e. drums, cymbals, various custom-made drumsticks, flutes, chairs, balance balls and balance cushions. FMT strives to support, strengthen and develop the person's physical, mental and social abilities. FMT-sessions (20 minuets/1 time a week) are performed individuelly (a patient with a educated music therapist). | Other | FMT arm |
Primary outcome
Improved quality of life
Time frame: Assessed every 2 weeks for 10 weeks.
Support, strengthen and develop the person's physical, mental and social abilities. Questionnaires concerning; body awareness, pain level, management of pain and fear of movement, pain-related activity limitations, emotions, depressive symptoms and anxiety, self-reported sick-leave and general perceived health will be used. The questionnaires are validated and psychometrically evaluated. Self-estimation (using different Lickert-scales). The results of phase 1 can contribute to the addition of more outcome measures in phase 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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. This study is not recruiting at the moment.
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?
A study testing Functionally oriented music therapy (FMT) in people with Long Term Musculoskeletal Pain, run by Mälardalen University at 1 site in Sweden.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Oct 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved quality of life (time frame: Assessed every 2 weeks for 10 weeks.). 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 9 Oct 2026.