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Clinical Trials/NCT05116020
NCT05116020
Completed
Not Applicable

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

Balgrist University Hospital1 site in 1 country568 target enrollmentMarch 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Pain
Sponsor
Balgrist University Hospital
Enrollment
568
Locations
1
Primary Endpoint
Change in musculoskeletal health status
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2022
End Date
March 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Balgrist University Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

  • Reasons for non-participation(Baseline)
  • Factors associated with non-response(Baseline and 12-weeks)

Study Sites (1)

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