NCT05116020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

September 8, 2021

Last Update Submit

April 25, 2023

Conditions

Keywords

ChiropracticMusculoskeletal healthMusculoskeletal painHealth care quality

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Reasons for non-participation

    Baseline

  • Factors associated with non-response

    Baseline and 12-weeks

Study Arms (1)

Chiropractic patient participants

Usual chiropractic care

Other: Usual chiropractic care

Interventions

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.

Chiropractic patient participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 35831057BACKGROUND
  • 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.

    PMID: 37024506BACKGROUND
  • Lalji R, Hofstetter L, Kongsted A, von Wyl V, Braun J, Puhan MA, Hincapie CA; Swiss ChiCo Clinicians Group. Swiss chiropractic cohort (Swiss ChiCo) pilot study: feasibility for a musculoskeletal cohort study conducted within a nationwide practice-based research network. Eur Spine J. 2024 May;33(5):2068-2078. doi: 10.1007/s00586-024-08175-z. Epub 2024 Mar 13.

Related Links

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cesar A Hincapié, DC PhD

    Balgrist University Hospital and University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

November 10, 2021

Study Start

March 28, 2022

Primary Completion

December 21, 2022

Study Completion

March 31, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Data may be made available for research purposes. Requests, including a synopsis of the study plan, can be addressed to the central contact person.

Locations