Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain

NCT00462241 | Completed DMC

• 1 other identifier: Project 73 - RCT (NMA)
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Chest Pain; Non-cardiac Chest Pain; Undiagnosed Chest Pain

Keywords

Chest pain; Chest wall; Atypical chest pain; Non-cardiac chest pain; Undiagnosed chest pain; Physical examination; Randomized controlled trial; Treatment study; Chiropractor

Outcome Measures

Primary Outcomes (2)

• Worst chest pain during the last week.

  7 days

• Patient-rated outcomes regarding improvement in chest pain.

  4 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

chiropractic treatment

EXPERIMENTAL

Individualised chiropractic treatment, pragmatic approach

Procedure: chiropractic treatment

self-management

SHAM COMPARATOR

Self-management: Minimal intervention - practice as usual.

Other: Self-management

Interventions

chiropractic treatment PROCEDURE

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.

chiropractic treatment

Self-management OTHER

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.

self-management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Locomotion Science: lead
• Nordic Institute of Chiropractic and Clinical Biomechanics: collaborator
• Odense University Hospital: collaborator
• University of Southern Denmark: collaborator
• The County of Funen, Denmark: collaborator
• Foundation for Chiropractic Research and Post Graduate Education: collaborator

Study Sites (1)

Dept. of Cardiology and Dept. of Nuclear Medicine, Odense University Hospital

Odense, DK-5000, Denmark

Location

Related Publications (19)

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

  PMID: 7064236 BACKGROUND

• 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.

  PMID: 1738954 BACKGROUND

• 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. doi: 10.1136/bmj.320.7240.951. No abstract available.

  PMID: 10753127 BACKGROUND

• 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. doi: 10.1097/00063110-200203000-00007.

  PMID: 11989492 BACKGROUND

• 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. doi: 10.1258/jrsm.96.3.122.

  PMID: 12612112 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.eurheartj.a014998.

  PMID: 8809520 BACKGROUND

• Berman DS, Germano G, Shaw LJ. The role of nuclear cardiology in clinical decision making. Semin Nucl Med. 1999 Oct;29(4):280-97. doi: 10.1016/s0001-2998(99)80017-8.

  PMID: 10534232 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000080946.42225.4D. No abstract available.

  PMID: 12975245 BACKGROUND

• 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.

  PMID: 9012090 BACKGROUND

• 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. doi: 10.1056/NEJM198011273032201.

  PMID: 7421961 BACKGROUND

• 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.

  PMID: 11855389 BACKGROUND

• 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. doi: 10.1016/0022-3999(95)00065-8.

  PMID: 8926607 BACKGROUND

• 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. doi: 10.1016/0002-8703(84)90546-5.

  PMID: 6731285 BACKGROUND

• Achem SR, DeVault KR. Recent developments in chest pain of undetermined origin. Curr Gastroenterol Rep. 2000 Jun;2(3):201-9. doi: 10.1007/s11894-000-0062-4.

  PMID: 10957931 BACKGROUND

• 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. doi: 10.1016/j.jmpt.2005.09.018.

  PMID: 16326234 BACKGROUND

• Stochkendahl MJ, Christensen HW, Vach W, Hoilund-Carlsen PF, Haghfelt T, Hartvigsen J. Chiropractic treatment vs self-management in patients with acute chest pain: a randomized controlled trial of patients without acute coronary syndrome. J Manipulative Physiol Ther. 2012 Jan;35(1):7-17. doi: 10.1016/j.jmpt.2010.11.004. Epub 2011 Dec 19.

  PMID: 22185955 RESULT

• Stochkendahl MJ, Christensen HW, Vach W, Hoilund-Carlsen PF, Haghfelt T, Hartvigsen J. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain: 1-year follow-up. J Manipulative Physiol Ther. 2012 May;35(4):254-62. doi: 10.1016/j.jmpt.2012.04.003.

  PMID: 22632585 RESULT

• Stochkendahl MJ, Sorensen J, Vach W, Christensen HW, Hoilund-Carlsen PF, Hartvigsen J. Cost-effectiveness of chiropractic care versus self-management in patients with musculoskeletal chest pain. Open Heart. 2016 May 4;3(1):e000334. doi: 10.1136/openhrt-2015-000334. eCollection 2016.

  PMID: 27175285 DERIVED

• Stochkendahl MJ, Christensen HW, Vach W, Hoilund-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. doi: 10.1186/1471-2474-9-40.

  PMID: 18377636 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Chest Pain

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mette J Stochkendahl, DC, MSci

  Nordic Institute of Chiropractic and Clinical Biomechanics

  PRINCIPAL INVESTIGATOR

• Jan Hartvigsen, DC, PhD

  Nordic Institute of Chiropractic and Clinical Biomechanics and University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DC, PhD

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: August 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

DK (1)