Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Other: Usual chiropractic care

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 Type: Observational
• Enrollment (Actual): 568

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons presenting to chiropractic clinic seeking new conservative health care for a musculoskeletal pain condition in Switzerland

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chiropractic patient participants; Usual chiropractic care	Other: Usual chiropractic care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks
Invited patient participation proportion	Proportion of invited patients who agree to participate (feasibility outcome)	Baseline
Change in participant follow-up and retention	Proportion of enrolled participants who complete follow-up surveys (feasibility outcome)	Baseline; 1-hour after initial visit; 2-, 6-, 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline and 12-weeks

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Collaborators: University of Zurich, Epidemiology, Biostatistics and Prevention Institute; University of Southern Denmark, Department of Sports Science and Clinical Biomechanics; Swiss Chiropractic Association (ChiroSuisse); Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland)
• Investigators: Principal Investigator: Cesar A Hincapié, DC PhD, Balgrist University Hospital and University of Zurich

Publications and helpful links

General 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.
• 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.

Helpful Links

• Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Project webpage
• Musculoskeletal Epidemiology Research Group, Balgrist University Hospital, Project webpage

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Musculoskeletal pain; Chiropractic; Health care quality; Musculoskeletal health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: SwissChiCo-Patient

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be made available for research purposes. Requests, including a synopsis of the study plan, can be addressed to the central contact person.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No