Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain (CARPA)
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|ClinicalTrials.gov Identifier: NCT00462241|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain||Procedure: chiropractic treatment Other: Self-management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 2: Treatment Study|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Experimental: chiropractic treatment
Individualised chiropractic treatment, pragmatic approach
Procedure: chiropractic treatment
Participants in the therapy group undergo a physical examination by an experienced, primary sector chiropractor, lasting up to one hour. The chiropractors choose an individual treatment strategy based on a combination of their findings, the patient history, and a standardized protocol reflecting routine practice. The standardized treatment protocol includes high velocity, low amplitude manipulation directed towards the thoracic and/or cervical spine in combination with any of the following: Joint mobilisation, soft tissue techniques, stretching, stabilising or strengthening exercises, heat or cold treatment, and advice. The protocol specifies up to ten treatment sessions of approximately 20 minutes, 1-3 times per week, or treatment until the patient is pain free. The chiropractors record the types of treatment rendered at sessions.
Sham Comparator: self-management
Self-management: Minimal intervention - practice as usual.
Advice group: Advice is directed towards promoting self-management. The participants are told that their chest pain generally has a benign, self limiting course. The participants receive individual instructions regarding posture and two or three exercises aiming to increase spinal or muscle stretch based on clinical evaluation. They are advised to seek medical attention for re-evaluation (general physician, chest pain clinic or emergency department) in case of severe or unfamiliar chest pain. The session lasts on average 15 minutes. Further, the advice group is also asked not to seek any manual treatment for the next four weeks.
- Worst chest pain during the last week. [ Time Frame: 7 days ]
- Patient-rated outcomes regarding improvement in chest pain. [ Time Frame: 4 weeks ]
- Pain assessment [ Time Frame: 7 days ]
- Patient-specific disability (Patient Specific Functional Scale) [ Time Frame: 4 weeks ]
- SF-36 [ Time Frame: 4 weeks ]
- Global assessment(Improvement in chest pain and general health is rated by the participants using a 7-point scale) [ Time Frame: 4 weeks ]
- Direct health care cost, direct non-health care costs and indirect costs are used in as the economic indicator of cost-effectiveness. [ Time Frame: 12 weeks ]
- EQ-5D (modified version) [ Time Frame: 4 weeks ]
- Non-prescription medication use, visits to non-study health care providers, and time off work. [ Time Frame: 12 weeks ]
- Adverse events (Information about adverse events and side effects will be collected by the treating chiropractor after each treatment session.) [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462241
|Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital|
|Odense, Denmark, DK-5000|
|Principal Investigator:||Mette J Stochkendahl, DC, MSci||Nordic Institute of Chiropractic and Clinical Biomechanics|
|Study Chair:||Jan Hartvigsen, DC, PhD||Nordic Institute of Chiropractic and Clinical Biomechanics and University of Southern Denmark|