Musculoskeletal PainNCT05116020
Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort
An observational study of Musculoskeletal Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The Swiss chiropractic patient cohort (Swiss ChiCo) study is a nationwide research project which aims to describe the characteristics of patients presenting to Swiss chiropractors, assess the clinical course of patients with musculoskeletal pain, and examine the feasibility for performing a larger subsequent cohort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Usual chiropractic care
- How many people
- 568 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Mar 2022to 31 Mar 2023
- 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: Persons presenting to chiropractic clinic seeking new conservative health care for a musculoskeletal pain condition in Switzerland
Who may be able to join
- ≥18 years of age
- Seeking new conservative health care for a musculoskeletal pain condition at a Swiss chiropractic clinic (ie, not having received participant-reported chiropractic care, physiotherapy, osteopathy, or massage therapy for the musculoskeletal complaint in the past 1 month and not a follow-up visit)
- Consent to chiropractic treatment
- Proficient in German, French, Italian, or English
- Active email account
- Willing to complete electronic study questionnaires
Who cannot join
- Presenting with red-flag symptoms (i.e., saddle anesthesia, loss of bowel and/or bladder control, history of major trauma, fracture, fever, severe or rapidly progressive neurologic deficit, sudden unexpected weight loss)
- Presenting with non-musculoskeletal pain condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swiss Chiropractic Cohort (Swiss ChiCo) Study: Prospective Clinical Cohort of Patients With Musculoskeletal Pain
The Swiss chiropractic patient cohort (Swiss ChiCo) study is a nationwide research project which aims to describe the characteristics of patients presenting to Swiss chiropractors, assess the clinical course of patients with musculoskeletal pain, and examine the feasibility for performing a larger subsequent cohort study.
Read the detailed description
The chiropractic scope of practice within Switzerland includes the diagnosis and management of musculoskeletal (MSK) pain conditions through manual medicine, prescription medication, and diagnostic imaging (radiography, ultrasound, CT, MRI). Common patient complaints presenting to Swiss chiropractic offices mirror this scope of practice, with low back pain and pelvic related pain being the most prevalent. This combination of clinical expertise and access to a MSK pain patient population allows chiropractic health care centres to become useful "real-world" primary care settings to further understand the current management and clinical course of MSK pain conditions in Switzerland, and to identify practice gaps and opportunities for Swiss MSK primary health care quality improvement.
This study aims to describe the characteristics of patients with new conservative healthcare seeking for MSK pain presenting to Swiss chiropractors, assess the clinical course of these patients over 12 weeks, and examine the feasibility for performing a larger subsequent prospective electronic cohort study using the newly established Swiss ChiCo practice-based research network (PBRN) and clinical cohort methodological framework.
Participating chiropractors will recruit consecutive patients from community-based chiropractic practices into a 12-week observational prospective electronic cohort study. Patient participants will be asked to complete 5 electronic surveys over 12-weeks. The first survey will be provided to patient participants prior to their initial chiropractic assessment. Subsequent questionnaires will be provided 1-hour, 2-weeks, 6-weeks, and 12-weeks after the initial visit. This patient cohort study represents a collaborative effort of international researchers, Swiss chiropractic clinicians, and the chiropractic patient and clinical associations in Switzerland (Pro Chiropractic Switzerland and ChiroSuisse). The survey design and study implementation procedures have been conceptualized through stakeholder consultation.
- Conditions
- Musculoskeletal Pain
- Being tested
- Usual chiropractic care
- Keywords
- Chiropractic, Musculoskeletal health, Musculoskeletal pain, Health care quality
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual chiropractic careOther
Usual chiropractic care in Switzerland can include spinal manual therapy, soft-tissue therapy, use of electric therapeutic modalities (low level laser therapy, therapeutic ultrasound, interferential current), acupuncture, prescription medication, exercise, education and reassurance.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic patient participants | Usual chiropractic care Receives: Other: Usual chiropractic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in musculoskeletal pain impact
Assessment via Pain, Enjoyment, and General Activity scale (PEG scale, 0-10). A higher score reflects worse outcome (worse pain intensity and interference)
Measured: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Change in musculoskeletal health status
Assessment via musculoskeletal health questionnaire (MSK-HQ, 0-56). A higher score reflects better musculoskeletal health status
Measured: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Invited patient participation proportion
Proportion of invited patients who agree to participate (feasibility outcome)
Measured: Baseline
Change in participant follow-up and retention
Proportion of enrolled participants who complete follow-up surveys (feasibility outcome)
Measured: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Secondary outcomes (2)
Reasons for non-participation
Reasons for invited participant non-participation (no email address, unfamiliar with electronic or internet tools, lack of time, lack of interest in the study, data privacy concerns, other)
Measured: Baseline
Factors associated with non-response
A multivariable logistic regression analysis will be performed to assess the association between the participant factors (listed below) and non-response (versus response) at 12-weeks follow-up. Participant factors that will be assessed are: age (reported in years), sex (reported as male and female), medication use for MSK pain (reported as prescription medication, non-prescription medication, and no medication use), current MSK pain condition episode duration (dichotomised as acute [< 3 months duration] and chronic [≥ 3 months duration]), MSK pain impact (PEG scale, 0-10), and MSK health status (MSK-HQ, 0-56) collected at baseline.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start28 Mar 2022
- Primary completion21 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 568 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
- NCT05116020
- Sponsor's protocol ID
- SwissChiCo-Patient
- 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 37024506Lalji R, Hofstetter L, Kongsted A, von Wyl V, Braun J, Puhan MA, Hincapie CA; Swiss ChiCo Clinicians Group. Swiss chiropractic cohort (Swiss ChiCo) pilot study: feasibility for a musculoskeletal cohort study conducted within a nationwide practice-based research network. Eur Spine J. 2024 May;33(5):2068-2078. doi: 10.1007/s00586-024-08175-z. Epub 2024 Mar 13.
PubMed 38480624
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: Prospective Clinical Cohort of Patients With Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05116020
- Acronym / sponsor ID
- SwissChiCo-Patient
- Conditions
- Musculoskeletal Pain
- Keywords
- Chiropractic, Musculoskeletal health, Musculoskeletal pain, Health care quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 568 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
- 28 Mar 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Nov 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 patient cohort (Swiss ChiCo) study is a nationwide research project which aims to describe the characteristics of patients presenting to Swiss chiropractors, assess the clinical course of patients with musculoskeletal pain, and examine the feasibility for performing a larger subsequent cohort study.
Detailed description
The chiropractic scope of practice within Switzerland includes the diagnosis and management of musculoskeletal (MSK) pain conditions through manual medicine, prescription medication, and diagnostic imaging (radiography, ultrasound, CT, MRI). Common patient complaints presenting to Swiss chiropractic offices mirror this scope of practice, with low back pain and pelvic related pain being the most prevalent. This combination of clinical expertise and access to a MSK pain patient population allows chiropractic health care centres to become useful "real-world" primary care settings to further understand the current management and clinical course of MSK pain conditions in Switzerland, and to identify practice gaps and opportunities for Swiss MSK primary health care quality improvement.
This study aims to describe the characteristics of patients with new conservative healthcare seeking for MSK pain presenting to Swiss chiropractors, assess the clinical course of these patients over 12 weeks, and examine the feasibility for performing a larger subsequent prospective electronic cohort study using the newly established Swiss ChiCo practice-based research network (PBRN) and clinical cohort methodological framework.
Participating chiropractors will recruit consecutive patients from community-based chiropractic practices into a 12-week observational prospective electronic cohort study. Patient participants will be asked to complete 5 electronic surveys over 12-weeks. The first survey will be provided to patient participants prior to their initial chiropractic assessment. Subsequent questionnaires will be provided 1-hour, 2-weeks, 6-weeks, and 12-weeks after the initial visit. This patient cohort study represents a collaborative effort of international researchers, Swiss chiropractic clinicians, and the chiropractic patient and clinical associations in Switzerland (Pro Chiropractic Switzerland and ChiroSuisse). The survey design and study implementation procedures have been conceptualized through stakeholder consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiropractic patient participants | – | Other: Usual chiropractic careUsual chiropractic care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons presenting to chiropractic clinic seeking new conservative health care for a musculoskeletal pain condition in Switzerland
Key inclusion criteria (6 listed)
- ≥18 years of age
- Seeking new conservative health care for a musculoskeletal pain condition at a Swiss chiropractic clinic (ie, not having received participant-reported chiropractic care, physiotherapy, osteopathy, or massage therapy for the musculoskeletal complaint in the past 1 month and not a follow-up visit)
- Consent to chiropractic treatment
- Proficient in German, French, Italian, or English
- Active email account
Key exclusion criteria (2 listed)
- Presenting with red-flag symptoms (i.e., saddle anesthesia, loss of bowel and/or bladder control, history of major trauma, fracture, fever, severe or rapidly progressive neurologic deficit, sudden unexpected weight loss)
- Presenting with non-musculoskeletal pain 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 |
|---|---|---|
| Usual chiropractic careUsual chiropractic care in Switzerland can include spinal manual therapy, soft-tissue therapy, use of electric therapeutic modalities (low level laser therapy, therapeutic ultrasound, interferential current), acupuncture, prescription medication, exercise, education and reassurance. | Other | Chiropractic patient participants |
Primary outcome
Change in musculoskeletal pain impact
Time frame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Assessment via Pain, Enjoyment, and General Activity scale (PEG scale, 0-10). A higher score reflects worse outcome (worse pain intensity and interference)
Change in musculoskeletal health status
Time frame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Assessment via musculoskeletal health questionnaire (MSK-HQ, 0-56). A higher score reflects better musculoskeletal health status
Invited patient participation proportion
Time frame: Baseline
Proportion of invited patients who agree to participate (feasibility outcome)
Change in participant follow-up and retention
Time frame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Proportion of enrolled participants who complete follow-up surveys (feasibility outcome)
2 secondary outcomes
Reasons for non-participation
Time frame: Baseline
Factors associated with non-response
Time frame: Baseline and 12-weeks
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.
- Background: 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.
- Derived from this study: PubMed 38480624Lalji R, Hofstetter L, Kongsted A, von Wyl V, Braun J, Puhan MA, Hincapie CA; Swiss ChiCo Clinicians Group. Swiss chiropractic cohort (Swiss ChiCo) pilot study: feasibility for a musculoskeletal cohort study conducted within a nationwide practice-based research network. Eur Spine J. 2024 May;33(5):2068-2078. doi: 10.1007/s00586-024-08175-z. Epub 2024 Mar 13.
- 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 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 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?
Change in musculoskeletal pain impact (time frame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks). 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 NCT05116020, which also lists 3 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.