Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 2: Treatment Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- Worst chest pain during the last week.
Study Overview
Brief Summary
Acute chest pain is a common cause of hospital admission. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome and coronary artery disease. However, a considerable number of patients may have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for this group of patients are scarce and there is a lack of formal clinical studies and validated outcome measures addressing the effect of manual treatment approaches.
Objective: This single blind randomized clinical trial investigates whether chiropractic treatment can reduce pain and improve function in a population of patients with acute, musculoskeletal chest pain when compared to advice directed towards promoting self-management.
Methods: Among patients admitted to a chest pain clinic in a university hospital under suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of musculoskeletal origin are included in the study. All patients have completed the chest pain clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest pain have been excluded. After completion of the study evaluation program, the patients are randomized into one of two groups: A) advice promoting self-management and individual instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the cervical and thoracic spine together with a choice of mobilisation and soft tissue techniques. In order to establish suitable outcome measures, two pilot studies were conducted. Outcome measures are pain, function, overall health, and patient-rated treatment effect measured at 4, 12, and 52 weeks following treatment.
Detailed Description
BACKGROUND
Acute chest pain is one of the most common reasons for hospital admission.(Bechgaard, 1982) In Denmark alone, more than 30,000 patients are admitted to medical departments because of chest pain.(Fruergaard, 1992) In the United States chest pain is the reason for 20-30 percent of all acute medical hospital admissions.(Capewell, 2000) However, an estimated 5-20 percent of all admissions to acute chest pain departments are caused by chest pain of musculoskeletal origin.(Knockaert 2002; Spalding 2003; Fruergaard 1996)
Chest pain patients with normal coronary anatomy have an excellent prognosis for survival and a future risk of cardiac morbidity similar to that reported in the background population.(Berman 1999; Klocke 2003) However, about three quarters of patients with non-cardiac chest pain continue to suffer from residual chest pain with large socio-economic consequences.(Spalding 2003; Launbjerg 1997; Ockene 1980; Eslick 2002; Tew 1995; Wielgosz 1984; Achem 2000)
An extensive body of literature addresses patient management protocols for patients presenting with chest pain primarily focusing on cardiopulmonary, gastroesophageal, and psychological conditions causing chest symptoms, but treatment protocols of musculoskeletal chest pain remain, however, scarce. Neither the effect of medical treatment (oral anti-inflammatory drug), exercise (strength and/or stretching), nor advice have been investigated. In particular, there is a lack of formal clinical studies examining the effectiveness of manual/manipulative approaches to manage musculoskeletal chest pain. To the best of the authors knowledge, only one study exists that deal with this aspect.(Christensen, 2005)
Therefore, the aim of this single-blind randomized clinical trial is to compare the effect of chiropractic treatment versus advice directed towards promoting self-management in a population of patients with musculoskeletal chest pain using standardized outcome measures. Further, a cost-effectiveness analysis along side the RCT will be performed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To be included in the project the participant must
- •Have chest pain as their primary complaint.
- •Have an acute episode of pain of less than 7 days duration before admission.
- •Consent to the standardized evaluation program at the chest pain clinic.
- •Have pain the in the thorax and/or neck.
- •Be able to read and understand Danish. Be between 18 and 75 year of age.
- •Be a resident of the Funen County.
- •Patients will not be included if any of the following conditions are present
- •Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG).
- •Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, ...).
- •Inflammatory joint disease.
- •Insulin dependent diabetes.
- •Fibromyalgia.
- •Malignant disease.
- •Apoplexy, dementia, or unable to cooperate.
- •Major osseous anomaly.
- •Osteoporosis.
- •Pregnancy.
- •Does not want to participate.
- •Other - the reason for non-inclusion will be registered.
Exclusion Criteria
- •Participants will be excluded following baseline evaluation if any of the following conditions are present
- •Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below).
- •New incidence of any of the above mentioned conditions/pathologies.
Outcomes
Primary Outcomes
Worst chest pain during the last week.
Time Frame: 7 days
Patient-rated outcomes regarding improvement in chest pain.
Time Frame: 4 weeks
Secondary Outcomes
- Pain assessment(7 days)
- Patient-specific disability (Patient Specific Functional Scale)(4 weeks)
- SF-36(4 weeks)
- Global assessment(Improvement in chest pain and general health is rated by the participants using a 7-point scale)(4 weeks)
- Direct health care cost, direct non-health care costs and indirect costs are used in as the economic indicator of cost-effectiveness.(12 weeks)
- EQ-5D (modified version)(4 weeks)
- Non-prescription medication use, visits to non-study health care providers, and time off work.(12 weeks)
- Adverse events (Information about adverse events and side effects will be collected by the treating chiropractor after each treatment session.)(4 weeks)
Investigators
Mette Jensen Stochkendahl
DC, PhD
Clinical Locomotion Science