Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Clinical Locomotion Science Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark Odense University Hospital University of Southern Denmark The County of Funen, Denmark Foundation for Advancement of Chiropractic Resaerch and Postgraduate Education. |
---|---|
Information provided by: | Clinical Locomotion Science |
ClinicalTrials.gov Identifier: | NCT00462241 |
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: Manual Therapy Other: Advice |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Non-Cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 2: Treatment Study |
Estimated Enrollment: | 120 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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
Patients will not be included if any of the following conditions are present
Exclusion Criteria:
Participants will be excluded following baseline evaluation if any of the following conditions are present
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 |
Study ID Numbers: | Project 73 - RCT (NMA) |
Study First Received: | April 17, 2007 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00462241 |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
Chest pain Chest wall Atypical chest pain Non-cardiac chest pain Undiagnosed chest pain |
Physical examination Randomized controlled trial Treatment study Chiropractor |
Signs and Symptoms Pain Chest Pain |