Musculoskeletal Diseases or ConditionsNCT04375007
Factors Related to the Number of Visits to PT in PHC
An observational study of Musculoskeletal Diseases or Conditions, run by Lund University at 1 site in Sweden.
Trial summary
Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. The aim was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapists… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Routine care
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 31 Jan 2018
- Phase
- Observational
- 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
Study population: Patients, visiting physiotherapist in primary health care in Sweden
Who may be able to join
- Patients, who seek physiotherapist for the first time for a musculoskeletal disorder, are over 18 years of age and are able to read, write and understand Swedish.
Who cannot join
- Patients, who have visited physiotherapist previous for the same musculoskeletal disorder and/or are diagnosed with malignant diseases. Patients, who suffer from dementia, severe mental illness or other conditions making them not able to understand the information about the study and not able to fill in the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Self-efficacy, Fear of Movement, Empowerment, Enablement and Number of Visits to Physiotherapist for Patients With Musculoskeletal Disorders in Primary Health Care: A Feasibility Study
Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. The aim was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapists among patients with a musculoskeletal disorder in primary health care. Design was apProspective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study.
Read the detailed description
Background: Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. Patients with musculoskeletal disorders are often treated by physiotherapists in primary health care. Psychosocial variables can be a significant obstacle to recover from musculoskeletal injuries.
The primary aim of this pilot study was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapist among patients with a musculoskeletal disorder in primary health care.
Methods: Prospective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study. Secondary outcomes included correlation between self-efficacy (Exercise Self-Efficacy Scale (ESES-S)), fear of movement (Tampa Scale for Kinesiophobia (TSK-SV)), empowerment (Making Decisions Scale ), enablement (Patient Enablement Instrument (PEI)) and number of visits to physiotherapist. Statistical analysis was done using IBM SPSS statistics version 24 with analysis of correlation using Spearman's rank correlation coefficient.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Routine care
- Keywords
- Physiotherapy, Musculoskeletal disorders, Self-efficacy, Empowerment, Enablement
- Medical subject headings
- Musculoskeletal Diseases, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Physiotherapy intervention in routine care
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rate, time to recruit
Measured: Through study completion, an average of 5 months
Number of visits
Count
Measured: Through study completion, an average of 5 months
Secondary outcomes (4)
Exercise self-efficacy
Questionnarie
Measured: At baseline
Kinesiophobia
Questionnarie
Measured: At baseline
Empowerment
Questionnaire
Measured: At baseline
Enablement
Questionnaire
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ekvall Hansson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375007
- Sponsor's protocol ID
- Number of visits to PT
- Status last verified
- May 2020
- First submitted
- 30 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not possible due to Swedish law
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Self-efficacy, Fear of Movement, Empowerment, Enablement and Number of Visits to Physiotherapist for Patients With Musculoskeletal Disorders in Primary Health Care: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04375007
- Acronym / sponsor ID
- Number of visits to PT
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Physiotherapy, Musculoskeletal disorders, Self-efficacy, Empowerment, Enablement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 5 May 2020 (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.
Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. The aim was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapists among patients with a musculoskeletal disorder in primary health care. Design was apProspective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study.
Detailed description
Background: Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. Patients with musculoskeletal disorders are often treated by physiotherapists in primary health care. Psychosocial variables can be a significant obstacle to recover from musculoskeletal injuries.
The primary aim of this pilot study was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapist among patients with a musculoskeletal disorder in primary health care.
Methods: Prospective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study. Secondary outcomes included correlation between self-efficacy (Exercise Self-Efficacy Scale (ESES-S)), fear of movement (Tampa Scale for Kinesiophobia (TSK-SV)), empowerment (Making Decisions Scale ), enablement (Patient Enablement Instrument (PEI)) and number of visits to physiotherapist. Statistical analysis was done using IBM SPSS statistics version 24 with analysis of correlation using Spearman's rank correlation coefficient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, visiting physiotherapist in primary health care in Sweden
Key inclusion criteria (1 listed)
- Patients, who seek physiotherapist for the first time for a musculoskeletal disorder, are over 18 years of age and are able to read, write and understand Swedish.
Key exclusion criteria (1 listed)
- Patients, who have visited physiotherapist previous for the same musculoskeletal disorder and/or are diagnosed with malignant diseases. Patients, who suffer from dementia, severe mental illness or other conditions making them not able to understand the information about the study and not able to fill in the questionnaires.
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 |
|---|---|---|
| Routine carePhysiotherapy intervention in routine care | Other | – |
Primary outcome
Recruitment
Time frame: Through study completion, an average of 5 months
Recruitment rate, time to recruit
Number of visits
Time frame: Through study completion, an average of 5 months
Count
4 secondary outcomes
Exercise self-efficacy
Time frame: At baseline
Kinesiophobia
Time frame: At baseline
Empowerment
Time frame: At baseline
Enablement
Time frame: At baseline
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 5 May 2020.
- Individual participant dataSharing planned: No. This is not possible due to Swedish law
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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.
Eva Ekvall Hansson, PhD principal investigator
Lund University
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, run by Lund 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 1 inclusion and 1 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 5 May 2020. 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?
Recruitment (time frame: Through study completion, an average of 5 months). The study lists 2 primary outcomes in all. 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 5 May 2020.