Non-cardiac Chest Pain Clinical Trial
Official title:
Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 2: Treatment Study
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.
BACKGROUND
Acute chest pain is one of the most common reasons for hospital admission.(Bechgaard, 1982)
In Denmark alone, more than 30,000 patients are admitted to medical departments because of
chest pain.(Fruergaard, 1992) In the United States chest pain is the reason for 20-30
percent of all acute medical hospital admissions.(Capewell, 2000) However, an estimated 5-20
percent of all admissions to acute chest pain departments are caused by chest pain of
musculoskeletal origin.(Knockaert 2002; Spalding 2003; Fruergaard 1996)
Chest pain patients with normal coronary anatomy have an excellent prognosis for survival
and a future risk of cardiac morbidity similar to that reported in the background
population.(Berman 1999; Klocke 2003) However, about three quarters of patients with
non-cardiac chest pain continue to suffer from residual chest pain with large socio-economic
consequences.(Spalding 2003; Launbjerg 1997; Ockene 1980; Eslick 2002; Tew 1995; Wielgosz
1984; Achem 2000)
An extensive body of literature addresses patient management protocols for patients
presenting with chest pain primarily focusing on cardiopulmonary, gastroesophageal, and
psychological conditions causing chest symptoms, but treatment protocols of musculoskeletal
chest pain remain, however, scarce. Neither the effect of medical treatment (oral
anti-inflammatory drug), exercise (strength and/or stretching), nor advice have been
investigated. In particular, there is a lack of formal clinical studies examining the
effectiveness of manual/manipulative approaches to manage musculoskeletal chest pain. To the
best of the authors knowledge, only one study exists that deal with this
aspect.(Christensen, 2005)
Therefore, the aim of this single-blind randomized clinical trial is to compare the effect
of chiropractic treatment versus advice directed towards promoting self-management in a
population of patients with musculoskeletal chest pain using standardized outcome measures.
Further, a cost-effectiveness analysis along side the RCT will be performed.
METHODS
Design: Single-blinded Randomized Trial.
Study sample:
The patients are recruited from a university hospital chest pain clinic. The chest pain
clinic is part of a large specialized cardiology department. All patients undergo a
standardized evaluation program ruling out acute coronary syndrome and any other obvious and
significant cardiac or non-cardiac disease. Sixty patients are to be included in each of the
two intervention groups, totaling 120 participants. The patients are included as a part of a
larger study on diagnosis of musculoskeletal chest pain.
Examination and baseline data:
Following discharge from the chest pain clinic, all patient records are screened for the
inclusion and non-inclusion criteria, and potential participants are invited to participate.
Within 7 days, participants are assessed in an individual baseline test. First, they
complete a battery of questionnaires including information on social, occupation, education,
physical and lifestyle factors, expectation to treatment outcome, and baseline values for
the outcome measure (see below). Signed consent forms are obtained from all participants.
Next, patients with musculoskeletal chest pain will be identified using a standardized
examination protocol. The examination protocol consists of 3 parts: 1) a semi-structured
interview (including pain characteristics, symptoms from the lungs and gastrointestinal
system, the past medical history, height and weight, and risk factors of ischemic heart
disease), 2) a general health examination (including blood pressure and pulse, heart and
lung stethoscopy, abdominal palpation, neck auscultation, and clinical signs of left
ventricular failure, neurological examination of upper and lower extremities in terms of
reflexes, sensibility to touch, muscle strength, as well as orthopaedic examination of the
neck and shoulder joints in order to rule out nerve root compression syndromes.), and 3) a
specific manual examination of the muscles and joints of the neck, thoracic spine and thorax
(including active range of motion, manual palpation for muscular tenderness on 14 point of
the anterior chest wall, palpation for paraspinal muscular tenderness segmentally, motion
palpation for joint-play restriction of the thoracic spine (Th1-8), and end play restriction
of the cervical and thoracic spine).
The examination program together with the detailed case history will be applied by the
clinician to the population of chest pain patients to make a diagnosis of pain from the
musculoskeletal system, Cervico-thoracic Angina (CTA).
Randomization:
Only CTA positive participants draw a sealed, opaque envelope numbered in succession and
containing information about treatment allocation. The randomization sequence is computer
generated. The envelopes are arranged in clusters of varying size. The examining clinician
manages the hand over of the envelope to the participant, but is blind to treatment
allocation.
Interventions:
CTA positive participants will be randomized to receive advice promoting self-management
(advice group) or a standard course of chiropractic treatment (therapy group).
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.
Therapy group: 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 mobilization, soft
tissue techniques, stretching, stabilizing 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.
Follow-up: Follow-up data are collected at four weeks, 3 months and one year (Figure 1)
Data analyzes: Data will be analyzed by a research group member blinded to group status. The
analysis will be based on the intention to treat principle. Both parametric and non
parametric principle will be used to compare treatment effects between the groups and to
identify baseline predictors for successful treatment outcome. Finally, based on a prior
definition of success, numbers needed to treat will be calculated.
Cost-effectiveness analysis: A cost comparison of the therapy and advice group will be
performed using data on direct and indirect costs. A cost-utility analysis comparing the
therapy and advice group will be performed using the EuroQol 5D.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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