Back Musculoskeletal DisordersPresKiNCT04177121
Qualitative Analysis of Physiotherapy Prescriptions From Primary Physicians for Patients With Back Musculoskeletal Disorders
An observational study of Back Musculoskeletal Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"Prescription in France is a major act of medical activity and must be in accordance with the scientific evidence. The use of physiotherapy by primary physicians is becoming more and more frequent and involves the performance of a prescription given to the patients so that they can access to their care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Back Musculoskeletal Disorders
- What is being tested?
- qualitative analysis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2019to 16 Mar 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with back musculoskeletal disorders
Who may be able to join
- Over the age of 18,
- Referred to a physiotherapist by a primary physician,
- Who have a prescription for physiotherapy,
- With back musculoskeletal disorders,
- Must be able to understand and speak French and legally consent to their participation in this study,
- Who did not oppose to participate in the study
Who cannot join
- Consulting the physiotherapist with a prescription for an indication other than a musculoskeletal condition of the spine
- Already taken in charge by a physiotherapist for another condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Analysis Based on Medical Records of 300 Patients With Back Musculoskeletal Disorders Receiving a Physiotherapy Prescription From Primary Physicians in France
"Prescription in France is a major act of medical activity and must be in accordance with the scientific evidence. The use of physiotherapy by primary physicians is becoming more and more frequent and involves the performance of a prescription given to the patients so that they can access to their care. The optimization of the use of this treatment is based on the respect of several legal and regulatory provisions allowing physiotherapists (PT) to offer the most appropriate treatment to the patient. Although these professionals can carry out a physiotherapy diagnosis and the objectives of care, as well as the choice of the acts and the techniques which seem to them the most appropriate. The performance of their treatment remains conditioned by the indication to physiotherapy and the anatomical region formulated by the prescription of the primary physicians. Primary physicians don't have the right to include their diagnostic hypothesis on the physiotherapy prescription. Therefore, they could transmit to the PT a supplementary report including all useful information for the PT which could influence the progress of the treatment.
It has been reported a frequent absence of diagnostic hypothesis formulated by the primary physicians to the PT to justify the indication to these treatment with the prescription. However, PT are led to formulate one or more diagnostic hypothesis following their clinical assessment. This can lead to questioning the interest of prescription for referring the patient from the primary physician to the PT.
Read more
The qualitative study by Panchout et al shows that 97.8% of the french private physiotherapists included treat patients with musculoskeletal disorders and 95.5% received those with back disorders. Back musculoskeletal disorders are the most common conditions reported from french private PT.
No French study has yet analyzed the quality of prescriptions formulated by primary physicians for private physiotherapists. Much foreign health systems have a different model of access to physiotherapy services compared to the French system, involving direct access physiotherapy for patients with musculoskeletal disorders. This care pathway gives patients the ability to refer themselves directly to a PT without having to see another health professional. Patients do not need a prescription in this model of access to physiotherapy care to use it.
Thus, in order to optimize the relevance of the use of physiotherapy for patients with back musculoskeletal disorders, we propose a prospective and cross-sectional observational study of 60 physiotherapists. The first aim of this study is to assess the relevance of the physiotherapy indication from primary care physicians for patients with back musculoskeletal disorders and consulting physiotherapists.
Read the detailed description
The main objective is to describe the contents of the documents transmitted by the primary physician to the physiotherapists relating to the physiotherapy management of patients with back musculoskeletal disorders, as well as their conformity with the results of the initial assessment of the physiotherapist.
The secondary objective is to evaluate the influence of the sociodemographic characteristics concerning the presence or the absence of diagnostic hypothesis on the primary physician documents transmitted to the physiotherapist.
The research is broken down into 9 steps:
- Physiotherapists practicing in France will be randomly selected from the list of registered members of the National Regulatory Authority of Physiotherapists and drawn by region to obtain a representative selection of territories of these professionals,
- The sending of patients medical records indicated to the physiotherapy for the management of a musculoskeletal condition whose prescription has been carried out by a primary physician will start from the first contacted physiotherapist who has agreed to participate in the study,
- Each of the 60 physiotherapists contacted and who have agreed to participate in the study will meet face-to-face about the progress of the project and the anonymization of the files,
- Physiotherapists will be asked to provide 5 medical records of patients each. The file may include: the prescription of physiotherapy given to the patient by the primary physician and / or any associated medical report transmitted to the physiotherapist by the primary physician before the start of treatment,
- To avoid selection bias, physiotherapists will collect patient data, not opposing their participation in the study, presenting themselves consecutively with a first prescription of physiotherapy,
- Each physiotherapist will have to anonymise on the documents: first and last name and contact information of the prescribing physician as well as the first name and the last name of the patient appearing on the prescription and associated reports. Each physiotherapist will be assigned a number (1, 2, 3, etc ...), similarly for primary physicians who prescribed physiotherapy to patients the consultant and the patients seen in consultation.
The statistical analysis will be carried out at the end of the study using SAS v9.3® Software under the responsibility of the clinical research unit.
Qualitative data will be expressed as numbers (percentage). Percentage comparisons with a Chi2 test (prescriptions without diagnostic hypothesis compared to prescriptions with diagnostic hypothesis) on the factors studied as being able to influence this criteria will be made. Comparisons of means with a non-parametric Kruskal-Wallis (or Wilcoxon) test will be performed.
- Conditions
- Back Musculoskeletal Disorders
- Being tested
- qualitative analysis
- Keywords
- Musculoskeletal disorders, Physician, Physiotherapy, Referral
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative analysisOther
Qualitative analysis of physiotherapy prescriptions
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of physiotherapy prescription
- Indication of physiotherapy (tltled present or absent),
- Therapeutic goals (titled present or absent),
- Number of sessions to be performed (titled present or absent and number),
- Anatomic region(s) to be treated (titled present or absent and region defined),
- Physiotherapy techniques to use (titled present or absent),
- Contraindications to physiotherapy (titled present or absent),
Measured: 8 months
ratio of associated medical report
- Diagnostic hypothesis (present or absent),
- Possible contraindications of certain physiotherapy techniques (present or absent).
Measured: 8 months
ratio of conclusions of the physiotherapy diagnostic report
- Indication to physiotherapy (yes/no),
- Diagnostic hypothesis of physiotherapists (in accordance or not with that of the prescription),
- Compliance with the prescription concerning the number and rhythm of the sessions to be performed, the anatomical region(s) to be treated and the physiotherapy techniques to be used (in accordance or not with that of the prescription)"
Measured: 8 months
Secondary outcomes (1)
Self-reported assessment for sociodemographic and clinical parameters from patients with back musculoskeletal disorders and physiotherapists included
The assessment will be self-reported related to the sociodemographic and clinical parameters of patients with back musculoskeletal disorders influencing the quality of the prescription with the following outcomes:
- Age,
- Gender,
- Residential city,
- Pathology,
And related to the sociodemographic and clinical parameters of physiotherapists included influencing the results of the physiotherapy diagnostic assessment:
- Age,
- Gender,
- City of exercise,
- Number of experience years,
- Continuing education program followed in the musculoskeletal field
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start25 Nov 2019
- Primary completion28 Feb 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie BOURMAUD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177121
- Sponsor's protocol ID
- 2019 / 441 CERDB
- Acronym
- PresKi
- Status last verified
- Jan 2020
- First submitted
- 4 Nov 2019
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demont A, Benaissa L, Recoque V, Desmeules F, Bourmaud A. Spinal pain patients seeking care in primary care and referred to physiotherapy: A cross-sectional study on patients characteristics, referral information and physiotherapy care offered by general practitioners and physiotherapists in France. PLoS One. 2022 Sep 6;17(9):e0274021. doi: 10.1371/journal.pone.0274021. eCollection 2022.
PubMed 36067139
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis Based on Medical Records of 300 Patients With Back Musculoskeletal Disorders Receiving a Physiotherapy Prescription From Primary Physicians in France
- ClinicalTrials.gov ID
- NCT04177121
- Acronym / sponsor ID
- PresKi / 2019 / 441 CERDB
- Conditions
- Back Musculoskeletal Disorders
- Keywords
- Musculoskeletal disorders, Physician, Physiotherapy, Referral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 26 Nov 2019 (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.
"Prescription in France is a major act of medical activity and must be in accordance with the scientific evidence. The use of physiotherapy by primary physicians is becoming more and more frequent and involves the performance of a prescription given to the patients so that they can access to their care. The optimization of the use of this treatment is based on the respect of several legal and regulatory provisions allowing physiotherapists (PT) to offer the most appropriate treatment to the patient. Although these professionals can carry out a physiotherapy diagnosis and the objectives of care, as well as the choice of the acts and the techniques which seem to them the most appropriate. The performance of their treatment remains conditioned by the indication to physiotherapy and the anatomical region formulated by the prescription of the primary physicians. Primary physicians don't have the right to include their diagnostic hypothesis on the physiotherapy prescription. Therefore, they could transmit to the PT a supplementary report including all useful information for the PT which could influence the progress of the treatment.
It has been reported a frequent absence of diagnostic hypothesis formulated by the primary physicians to the PT to justify the indication to these treatment with the prescription. However, PT are led to formulate one or more diagnostic hypothesis following their clinical assessment. This can lead to questioning the interest of prescription for referring the patient from the primary physician to the PT.
The qualitative study by Panchout et al shows that 97.8% of the french private physiotherapists included treat patients with musculoskeletal disorders and 95.5% received those with back disorders. Back musculoskeletal disorders are the most common conditions reported from french private PT.
No French study has yet analyzed the quality of prescriptions formulated by primary physicians for private physiotherapists. Much foreign health systems have a different model of access to physiotherapy services compared to the French system, involving direct access physiotherapy for patients with musculoskeletal disorders. This care pathway gives patients the ability to refer themselves directly to a PT without having to see another health professional. Patients do not need a prescription in this model of access to physiotherapy care to use it.
Thus, in order to optimize the relevance of the use of physiotherapy for patients with back musculoskeletal disorders, we propose a prospective and cross-sectional observational study of 60 physiotherapists. The first aim of this study is to assess the relevance of the physiotherapy indication from primary care physicians for patients with back musculoskeletal disorders and consulting physiotherapists.
Detailed description
The main objective is to describe the contents of the documents transmitted by the primary physician to the physiotherapists relating to the physiotherapy management of patients with back musculoskeletal disorders, as well as their conformity with the results of the initial assessment of the physiotherapist.
The secondary objective is to evaluate the influence of the sociodemographic characteristics concerning the presence or the absence of diagnostic hypothesis on the primary physician documents transmitted to the physiotherapist.
The research is broken down into 9 steps:
- Physiotherapists practicing in France will be randomly selected from the list of registered members of the National Regulatory Authority of Physiotherapists and drawn by region to obtain a representative selection of territories of these professionals,
- The sending of patients medical records indicated to the physiotherapy for the management of a musculoskeletal condition whose prescription has been carried out by a primary physician will start from the first contacted physiotherapist who has agreed to participate in the study,
- Each of the 60 physiotherapists contacted and who have agreed to participate in the study will meet face-to-face about the progress of the project and the anonymization of the files,
- Physiotherapists will be asked to provide 5 medical records of patients each. The file may include: the prescription of physiotherapy given to the patient by the primary physician and / or any associated medical report transmitted to the physiotherapist by the primary physician before the start of treatment,
- To avoid selection bias, physiotherapists will collect patient data, not opposing their participation in the study, presenting themselves consecutively with a first prescription of physiotherapy,
- Each physiotherapist will have to anonymise on the documents: first and last name and contact information of the prescribing physician as well as the first name and the last name of the patient appearing on the prescription and associated reports. Each physiotherapist will be assigned a number (1, 2, 3, etc ...), similarly for primary physicians who prescribed physiotherapy to patients the consultant and the patients seen in consultation.
The statistical analysis will be carried out at the end of the study using SAS v9.3® Software under the responsibility of the clinical research unit.
Qualitative data will be expressed as numbers (percentage). Percentage comparisons with a Chi2 test (prescriptions without diagnostic hypothesis compared to prescriptions with diagnostic hypothesis) on the factors studied as being able to influence this criteria will be made. Comparisons of means with a non-parametric Kruskal-Wallis (or Wilcoxon) test will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with back musculoskeletal disorders
Key inclusion criteria (6 listed)
- Over the age of 18,
- Referred to a physiotherapist by a primary physician,
- Who have a prescription for physiotherapy,
- With back musculoskeletal disorders,
- Must be able to understand and speak French and legally consent to their participation in this study,
Key exclusion criteria (2 listed)
- Consulting the physiotherapist with a prescription for an indication other than a musculoskeletal condition of the spine
- Already taken in charge by a physiotherapist for another condition
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 |
|---|---|---|
| qualitative analysisQualitative analysis of physiotherapy prescriptions | Other | – |
Primary outcome
ratio of physiotherapy prescription
Time frame: 8 months
* Indication of physiotherapy (tltled present or absent), * Therapeutic goals (titled present or absent), * Number of sessions to be performed (titled present or absent and number), * Anatomic region(s) to be treated (titled present or absent and region defined), * Physiotherapy techniques to use (titled present or absent), * Contraindications to physiotherapy (titled present or absent),
ratio of associated medical report
Time frame: 8 months
* Diagnostic hypothesis (present or absent), * Possible contraindications of certain physiotherapy techniques (present or absent).
ratio of conclusions of the physiotherapy diagnostic report
Time frame: 8 months
* Indication to physiotherapy (yes/no), * Diagnostic hypothesis of physiotherapists (in accordance or not with that of the prescription), * Compliance with the prescription concerning the number and rhythm of the sessions to be performed, the anatomical region(s) to be treated and the physiotherapy techniques to be used (in accordance or not with that of the prescription)"
1 secondary outcome
Self-reported assessment for sociodemographic and clinical parameters from patients with back musculoskeletal disorders and physiotherapists included
Time frame: 8 months
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 6 Feb 2023.
- Results publication: PubMed 36067139Demont A, Benaissa L, Recoque V, Desmeules F, Bourmaud A. Spinal pain patients seeking care in primary care and referred to physiotherapy: A cross-sectional study on patients characteristics, referral information and physiotherapy care offered by general practitioners and physiotherapists in France. PLoS One. 2022 Sep 6;17(9):e0274021. doi: 10.1371/journal.pone.0274021. eCollection 2022.
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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.
Aurélie BOURMAUD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Back Musculoskeletal Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 2 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 6 Feb 2023. 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 France. 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?
ratio of physiotherapy prescription (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177121, which also lists 1 linked publication.
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 6 Feb 2023.