Clinical trial NCT05116020: Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort
Official title: Swiss Chiropractic Cohort (Swiss ChiCo) Study: Prospective Clinical Cohort of Patients With Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Keywords: Chiropractic
Musculoskeletal health
Musculoskeletal pain
Health care quality
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: University of Southern Denmark, Department of Sports Science and Clinical Biomechanics
name: Swiss Chiropractic Association (ChiroSuisse)
name: Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland)
First posted: 2021-11-10
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons presenting to chiropractic clinic seeking new conservative health care for a musculoskeletal pain condition in Switzerland

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in musculoskeletal pain impact
timeFrame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
measure: Change in musculoskeletal health status
timeFrame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
measure: Invited patient participation proportion
timeFrame: Baseline
measure: Change in participant follow-up and retention
timeFrame: Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Secondary outcomes:
measure: Reasons for non-participation
timeFrame: Baseline
measure: Factors associated with non-response
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital and University of Zurich
name: Cesar A Hincapié, DC PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lalji 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.