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临床试验/NCT05116020
NCT05116020已完成不适用

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

Balgrist University Hospital1 个研究点 分布在 1 个国家目标入组 568 人开始时间: 2022年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
568
试验地点
1
主要终点
Change in musculoskeletal health status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥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

排除标准

  • 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

结局指标

主要结局

Change in musculoskeletal health status

时间窗: 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

时间窗: Baseline

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

Change in participant follow-up and retention

时间窗: 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

时间窗: 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)

次要结局

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

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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