Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain
Condition: Musculoskeletal Chest Pain; Non-cardiac Chest Pain; Undiagnosed Chest Pain
MeSH terms: Chest Pain
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): chiropractic treatment; Self-management
Intervention type(s): Procedure; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chest pain; Chest wall; Atypical chest pain; Non-cardiac chest pain; Undiagnosed chest pain; Physical examination; Randomized controlled trial; Treatment study; Chiropractor