Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort

Musculoskeletal Pain Clinical Trial

Official title:

Swiss Chiropractic Cohort (Swiss ChiCo) Study: Prospective Clinical Cohort of Patients With Musculoskeletal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05116020
• Other study ID #: SwissChiCo-Patient
• Status: Completed
• Start date: March 28, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: March 31, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
Balgrist University Hospital	Swiss Chiropractic Association (ChiroSuisse), Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland), University of Southern Denmark, Department of Sports Science and Clinical Biomechanics, University of Zurich, Epidemiology, Biostatistics and Prevention Institute

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Invited patient participation proportion	Proportion of invited patients who agree to participate (feasibility outcome)	Baseline
Primary	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	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
Secondary	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

External Links

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