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NCT Number: NCT05116020

Swiss Chiropractic Cohort (Swiss ChiCo) Study: Patient Cohort

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual chiropractic care

Other

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.

Primary outcomes

  1. 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)

  2. 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

  3. Invited patient participation proportion

    Time frame: Baseline

    Proportion of invited patients who agree to participate (feasibility outcome)

  4. 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)

Secondary outcomes

  1. Reasons for non-participation

    Time frame: Baseline

    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)

  2. Factors associated with non-response

    Time frame: Baseline and 12-weeks

    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.

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • Swiss Chiropractic Association (ChiroSuisse)
  • Swiss Chiropractic Patient Association (Pro Chiropractic Switzerland)
  • University of Southern Denmark
  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 10, 2021
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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