Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain - Full Text View

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

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: Manual Therapy Other: Advice

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

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

Further study details as provided by Clinical Locomotion Science:

Primary Outcome Measures:

Worst chest pain during the last week. [ Time Frame: 7 days ]
Patient-rated outcomes regarding improvement in chest pain. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:

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 ]

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)

Intervention Details:

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.

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.

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462241

Locations

Denmark
Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital
Odense, Denmark, DK-5000

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.

Investigators

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

Related Info This link exits the ClinicalTrials.gov site

Publications:

Bechgaard P. [Segmentally thoracic pain in patients admitted to a coronary care unit] Ugeskr Laeger. 1982 Jan 4;144(1):13-5. Danish. No abstract available.

Fruergaard P, Launbjerg J, Falch JF, Elsborg L, Hesse B, Jorgensen FB, Petri A, Mellemgaard K. [Differential diagnosis in acute chest pain and suspected myocardial infarction. A pilot study] Ugeskr Laeger. 1992 Jan 13;154(3):138-41. Danish.

Capewell S, McMurray J. "Chest pain-please admit": is there an alternative?. A rapid cardiological assessment service may prevent unnecessary admissions. BMJ. 2000 Apr 8;320(7240):951-2. No abstract available.

Knockaert DC, Buntinx F, Stoens N, Bruyninckx R, Delooz H. Chest pain in the emergency department: the broad spectrum of causes. Eur J Emerg Med. 2002 Mar;9(1):25-30.

Spalding L, Reay E, Kelly C. Cause and outcome of atypical chest pain in patients admitted to hospital. J R Soc Med. 2003 Mar;96(3):122-5.

Fruergaard P, Launbjerg J, Hesse B, Jorgensen F, Petri A, Eiken P, Aggestrup S, Elsborg L, Mellemgaard K. The diagnoses of patients admitted with acute chest pain but without myocardial infarction. Eur Heart J. 1996 Jul;17(7):1028-34.

Berman DS, Germano G, Shaw LJ. The role of nuclear cardiology in clinical decision making. Semin Nucl Med. 1999 Oct;29(4):280-97. Review.

Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, O'Gara PT, Carabello BA, Russell RO Jr, Cerqueira MD, St John Sutton MG, DeMaria AN, Udelson JE, Kennedy JW, Verani MS, Williams KA, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Society for Nuclear Cardiology. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). Circulation. 2003 Sep 16;108(11):1404-18. No abstract available.

Launbjerg J, Fruergaard P, Hesse B, Jorgensen F, Elsborg L, Petri A. [The long-term prognosis of patients with acute chest pain of various origins] Ugeskr Laeger. 1997 Jan 6;159(2):175-9. Danish.

Ockene IS, Shay MJ, Alpert JS, Weiner BH, Dalen JE. Unexplained chest pain in patients with normal coronary arteriograms: a follow-up study of functional status. N Engl J Med. 1980 Nov 27;303(22):1249-52.

Eslick GD, Coulshed DS. Rapid assessment of chest pain. Chest pain clinics may be one step forward, two steps back. BMJ. 2002 Feb 16;324(7334):422. No abstract available.

Tew R, Guthrie EA, Creed FH, Cotter L, Kisely S, Tomenson B. A long-term follow-up study of patients with ischaemic heart disease versus patients with nonspecific chest pain. J Psychosom Res. 1995 Nov;39(8):977-85.

Wielgosz AT, Fletcher RH, McCants CB, McKinnis RA, Haney TL, Williams RB. Unimproved chest pain in patients with minimal or no coronary disease: a behavioral phenomenon. Am Heart J. 1984 Jul;108(1):67-72.

Achem SR, DeVault KR. Recent developments in chest pain of undetermined origin. Curr Gastroenterol Rep. 2000 Jun;2(3):201-9. Review.

Christensen HW, Vach W, Gichangi A, Manniche C, Haghfelt T, Hoilund-Carlsen PF. Manual therapy for patients with stable angina pectoris: a nonrandomized open prospective trial. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):654-61.

Publications indexed to this study:

Stochkendahl MJ, Christensen HW, Vach W, Høilund-Carlsen PF, Haghfelt T, Hartvigsen J. Diagnosis and treatment of musculoskeletal chest pain: design of a multi-purpose trial. BMC Musculoskelet Disord. 2008 Mar 31;9:40.

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

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

Study placed in the following topic categories:

Signs and Symptoms
Pain
Chest Pain

ClinicalTrials.gov processed this record on January 16, 2009