Musculoskeletal PainNCT05046249
Swiss Chiropractic Cohort (Swiss ChiCo) Study: A Nationwide Practice-Based Research Network Project
An observational study of Musculoskeletal Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The Swiss chiropractic cohort (Swiss ChiCo) practice-based research network (PBRN) is nationwide research project with the aim to develop a musculoskeletal focused PBRN within the Swiss chiropractic setting and describe the characteristics of clinicians recruited. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 151 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2021to 19 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All active chiropractors in Switzerland
Who may be able to join
- Active clinician members of the Swiss Chiropractic Association (ChiroSuisse)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The Swiss chiropractic cohort (Swiss ChiCo) practice-based research network (PBRN) is nationwide research project with the aim to develop a musculoskeletal focused PBRN within the Swiss chiropractic setting and describe the characteristics of clinicians recruited. Development of the PBRN has been guided through participatory engagement of multiple stakeholders including patients, clinicians, scientists, and policymakers.
Read the detailed description
Management of musculoskeletal (MSK) conditions is moving away from traditional medical treatments such as pain medication and towards more physical and preventative approaches. As a result, there is a need to describe manual care approaches to make informed decisions on how best to use this capacity in the current health care system. While this literature is emerging, very little is collected from clinical settings where the large majority of MSK care occurs. The lack of clinically collected data creates gaps in patient-centred research and difficulties with knowledge implementation in treatment settings.
To help bridge this divide, countries such as the United Kingdom, Canada, Sweden, and Australia have established MSK-focused practice-based research networks (PBRNs). PBRNs are sustained collaborations between practitioners and academicians. This collaboration allows patient recruitment from diverse clinical settings and allows practitioners to be more actively involved in the research process. As a result data collected, and subsequent recommendations may have greater clinical utility than that which comes from more traditional research-only settings.
This study aims to develop a MSK focused PBRN within the Swiss chiropractic setting and describe the characteristics of clinicians recruited. It represents a collaborative effort of international researchers, Swiss chiropractic clinicians, and the chiropractic patient and clinical associations in Switzerland (Pro Chiropractic Switzerland and ChiroSuisse). Clinicians will endorse participation in the PBRN by completing an electronic study form. Once established, nested sub-studies will be conducted within this new clinical research environment. Through stakeholder engagement and institutional support, the Swiss ChiCo PBRN can serve as an important resource to advance chiropractic and MSK health services research.
- Conditions
- Musculoskeletal Pain
- Keywords
- Chiropractic, Health care quality, Musculoskeletal health, Manual medicine
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic clinicians | Swiss chiropractic clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-confidence in clinical management of patients with low back pain
Assessment via practitioner self-confidence scale (PCS, 4-20). The PCS contains four items with a total score of 20 where 4 represents greatest self-confidence and 20 represents the lowest self-confidence towards clinical management of patients with low back pain.
Measured: Baseline
Biomedical versus biopsychosocial treatment orientation
Assessment via pain attitudes and beliefs scale musculoskeletal version (PABS-MSK). The PABS-MSK contains two domains, a higher score on the biomedical domain (PABS-MSK-BM, score range 10-60) represents a higher biomedical orientation. A higher score on the biopsychosocial domain (PABS-MSK-BPS, score range 10-60) represents a higher biopsychosocial orientation.
Measured: Baseline
Participation proportion (feasibility outcome)
Proportion of eligible clinicians who participate
Measured: Baseline
Motivation for clinician participation in a PBRN sub-study (feasibility outcome)
Assessment via visual analog scale (VAS, 0-100). A higher score reflects higher motivation for clinician participation in a PBRN sub-study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start9 Sep 2021
- Primary completion19 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University of Southern Denmark, Swiss Chiropractic Association (ChiroSuisse), Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland)
- Responsible party
- Sponsor
- Investigators
- Cesar A Hincapié, DC PhD, Principal investigator, Balgrist University Hospital and University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046249
- Sponsor's protocol ID
- SwissChiCo-PBRN
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be made available for research purposes. Requests, including a synopsis of the study plan, can be addressed to the central contact person.
Publications
Lalji R, Hofstetter L, Kongsted A, von Wyl V, Puhan MA, Hincapie CA. Swiss chiropractic practice-based research network and musculoskeletal pain cohort pilot study: protocol of a nationwide resource to advance musculoskeletal health services research. BMJ Open. 2022 Jul 13;12(7):e059380. doi: 10.1136/bmjopen-2021-059380.
PubMed 35831057Lalji R, Hofstetter L, Kongsted A, von Wyl V, Puhan MA, Hincapie CA. The Swiss chiropractic practice-based research network: a population-based cross-sectional study to inform future musculoskeletal research. Sci Rep. 2023 Apr 6;13(1):5655. doi: 10.1038/s41598-023-32437-3.
PubMed 37024506
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Chiropractic Cohort (Swiss ChiCo) Study: A Nationwide Practice-Based Research Network Project
- ClinicalTrials.gov ID
- NCT05046249
- Acronym / sponsor ID
- SwissChiCo-PBRN
- Conditions
- Musculoskeletal Pain
- Keywords
- Chiropractic, Health care quality, Musculoskeletal health, Manual medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich, University of Southern Denmark, Swiss Chiropractic Association (ChiroSuisse), Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 16 Sep 2021 (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 Swiss chiropractic cohort (Swiss ChiCo) practice-based research network (PBRN) is nationwide research project with the aim to develop a musculoskeletal focused PBRN within the Swiss chiropractic setting and describe the characteristics of clinicians recruited. Development of the PBRN has been guided through participatory engagement of multiple stakeholders including patients, clinicians, scientists, and policymakers.
Detailed description
Management of musculoskeletal (MSK) conditions is moving away from traditional medical treatments such as pain medication and towards more physical and preventative approaches. As a result, there is a need to describe manual care approaches to make informed decisions on how best to use this capacity in the current health care system. While this literature is emerging, very little is collected from clinical settings where the large majority of MSK care occurs. The lack of clinically collected data creates gaps in patient-centred research and difficulties with knowledge implementation in treatment settings.
To help bridge this divide, countries such as the United Kingdom, Canada, Sweden, and Australia have established MSK-focused practice-based research networks (PBRNs). PBRNs are sustained collaborations between practitioners and academicians. This collaboration allows patient recruitment from diverse clinical settings and allows practitioners to be more actively involved in the research process. As a result data collected, and subsequent recommendations may have greater clinical utility than that which comes from more traditional research-only settings.
This study aims to develop a MSK focused PBRN within the Swiss chiropractic setting and describe the characteristics of clinicians recruited. It represents a collaborative effort of international researchers, Swiss chiropractic clinicians, and the chiropractic patient and clinical associations in Switzerland (Pro Chiropractic Switzerland and ChiroSuisse). Clinicians will endorse participation in the PBRN by completing an electronic study form. Once established, nested sub-studies will be conducted within this new clinical research environment. Through stakeholder engagement and institutional support, the Swiss ChiCo PBRN can serve as an important resource to advance chiropractic and MSK health services research.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiropractic clinicians | – | –Swiss chiropractic clinicians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All active chiropractors in Switzerland
Key inclusion criteria (1 listed)
- Active clinician members of the Swiss Chiropractic Association (ChiroSuisse)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-confidence in clinical management of patients with low back pain
Time frame: Baseline
Assessment via practitioner self-confidence scale (PCS, 4-20). The PCS contains four items with a total score of 20 where 4 represents greatest self-confidence and 20 represents the lowest self-confidence towards clinical management of patients with low back pain.
Biomedical versus biopsychosocial treatment orientation
Time frame: Baseline
Assessment via pain attitudes and beliefs scale musculoskeletal version (PABS-MSK). The PABS-MSK contains two domains, a higher score on the biomedical domain (PABS-MSK-BM, score range 10-60) represents a higher biomedical orientation. A higher score on the biopsychosocial domain (PABS-MSK-BPS, score range 10-60) represents a higher biopsychosocial orientation.
Participation proportion (feasibility outcome)
Time frame: Baseline
Proportion of eligible clinicians who participate
Motivation for clinician participation in a PBRN sub-study (feasibility outcome)
Time frame: Baseline
Assessment via visual analog scale (VAS, 0-100). A higher score reflects higher motivation for clinician participation in a PBRN sub-study.
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 26 Apr 2023.
- Background: PubMed 35831057Lalji R, Hofstetter L, Kongsted A, von Wyl V, Puhan MA, Hincapie CA. Swiss chiropractic practice-based research network and musculoskeletal pain cohort pilot study: protocol of a nationwide resource to advance musculoskeletal health services research. BMJ Open. 2022 Jul 13;12(7):e059380. doi: 10.1136/bmjopen-2021-059380.
- Results publication: PubMed 37024506Lalji R, Hofstetter L, Kongsted A, von Wyl V, Puhan MA, Hincapie CA. The Swiss chiropractic practice-based research network: a population-based cross-sectional study to inform future musculoskeletal research. Sci Rep. 2023 Apr 6;13(1):5655. doi: 10.1038/s41598-023-32437-3.
- Musculoskeletal Epidemiology Research Group, Balgrist University Hospital, Project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data may be made available for research purposes. Requests, including a synopsis of the study plan, can be addressed to the central contact person.
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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.
Cesar A Hincapié, DC PhD principal investigator
Balgrist University Hospital and University of Zurich
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 Pain, run by Balgrist University Hospital at 1 site in Switzerland.
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 0 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 26 Apr 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 Switzerland. 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?
Self-confidence in clinical management of patients with low back pain (time frame: Baseline). The study lists 4 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 NCT05046249, which also lists 2 linked publications.
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 26 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.