Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462241
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2007-04-17
Brief Title:
Treatment Study Comparing Manual Treatment or Advice in Acute Musculoskeletal Chest Pain
Sponsor:
Clinical Locomotion Science
Organization:
Clinical Locomotion Science
Study Overview
Official Title:
Non-cardiac Chest Pain Evaluation and Treatment Study CARPA - Part 2 Treatment Study
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARPA
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
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 admissionBechgaard 1982 In Denmark alone more than 30000 patients are admitted to medical departments because of chest painFruergaard 1992 In the United States chest pain is the reason for 20-30 percent of all acute medical hospital admissionsCapewell 2000 However an estimated 5-20 percent of all admissions to acute chest pain departments are caused by chest pain of musculoskeletal originKnockaert 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 populationBerman 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 consequencesSpalding 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 andor stretching nor advice have been investigated In particular there is a lack of formal clinical studies examining the effectiveness of manualmanipulative approaches to manage musculoskeletal chest pain To the best of the authors knowledge only one study exists that deal with this aspectChristensen 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 andor 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
Acute chest pain is one of the most common reasons for hospital admissionBechgaard 1982 In Denmark alone more than 30000 patients are admitted to medical departments because of chest painFruergaard 1992 In the United States chest pain is the reason for 20-30 percent of all acute medical hospital admissionsCapewell 2000 However an estimated 5-20 percent of all admissions to acute chest pain departments are caused by chest pain of musculoskeletal originKnockaert 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 populationBerman 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 consequencesSpalding 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 andor stretching nor advice have been investigated In particular there is a lack of formal clinical studies examining the effectiveness of manualmanipulative approaches to manage musculoskeletal chest pain To the best of the authors knowledge only one study exists that deal with this aspectChristensen 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None