NCT06600685

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

September 9, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessed every 2 weeks for 10 weeks.

Study Arms (1)

FMT arm

OTHER
Other: Functionally oriented music therapy (FMT)

Interventions

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).

FMT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FMT centrum

Eskilstuna, Eskilstuna, 633 42, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations