Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain (CARPA)
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Purpose
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 | Intervention |
|---|---|
|
Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain |
Procedure: chiropractic treatment Other: Self-management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 2: Treatment Study |
- Worst chest pain during the last week. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Patient-rated outcomes regarding improvement in chest pain. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Pain assessment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Patient-specific disability (Patient Specific Functional Scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Global assessment(Improvement in chest pain and general health is rated by the participants using a 7-point scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- EQ-5D (modified version) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Non-prescription medication use, visits to non-study health care providers, and time off work. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse events (Information about adverse events and side effects will be collected by the treating chiropractor after each treatment session.) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 115 |
| Study Start Date: | August 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: Self-management
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
- ACS.
- 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.
Contacts and Locations| Denmark | |
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mette Jensen Stochkendahl, DC, PhD, Clinical Locomotion Science |
| ClinicalTrials.gov Identifier: | NCT00462241 History of Changes |
| Other Study ID Numbers: | Project 73 - RCT (NMA) |
| Study First Received: | April 17, 2007 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Clinical Locomotion Science:
|
Chest pain Chest wall Atypical chest pain Non-cardiac chest pain Undiagnosed chest pain |
Physical examination Randomized controlled trial Treatment study Chiropractor |
Additional relevant MeSH terms:
|
Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013