The Comparative Effectiveness of Interventions in People With Neck Pain Who Exhibit Directional Preference

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare physical therapy treatments in people with neck pain. The main aim is to compare the short-term effectiveness of physical therapy treatment for neck pain as delivered through Mechanical Diagnosis and Therapy (MDT) as compared to the Cervical Spine Clinical Practice Guidelines (CPGs) in patients with neck pain. Participants will be randomly allocated to receive treatment according to MDT or CPG guidelines. Researchers will compare outcomes between the two groups over 1 year.

Detailed Description
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Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. The primary aim of this study is to compare outcomes in people treated according to MDT or the CPGs.

Official Title
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The Comparative Effectiveness of Mechanical Diagnosis and Therapy and Management According to the Cervical Spine Clinical Practice Guidelines in People With Neck Pain Who Exhibit Directional Preference: A Randomized Clinical Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Management according to Mechanical Diagnosis and Therapy
* Other: Management according to the Cervical Spine Clinical Practice Guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are consecutively referred to physical therapy for the treatment of neck pain will be recruited from three hospital-based outpatient physical therapy clinics. Patients will be included if they demonstrate directional preference in the physical therapy initial examination. Patients aged 18-90 years Exclusion Criteria: Patients will be excluded if they: Have a history of spinal surgery Have cervical instability, and/or vertebral basilar insufficiency Have a serious medical condition such as cancer, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis, or other related autoimmune diseases Are currently pregnant Are positive for upper motor neuron signs Are experiencing problems with dizziness, tinnitus, swallowing, or bowel and bladder dysfunction. Do not experience directional preference in the physical therapy initial examination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly allocated to one of two treatment groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical Diagnosis and Therapy (MDT)<br>MDT is a system of examination and intervention based on the patient's response to repeated end range neck movements. | Other: Management according to Mechanical Diagnosis and Therapy<br>* MDT management is based on the patient response to repeated end range movements.<br>|
| Active Comparator: Cervical Spine Clinical Practice Guidelines (CPGs)<br>The CPGs are guidelines for examination and intervention based on a summary of research conducted on people with neck pain. | Other: Management according to the Cervical Spine Clinical Practice Guidelines<br>* CPG management is based on clinical research regarding management of people with neck pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | The NDI is an outcome tool used to measure patient's perceived level of function in relation to their neck pain. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Avoidance Belief Questionnaire (FABQ) | The FABQ is an outcome tool used to measure a patient's fear in relation to their neck pain. | 1 year | 
| Numerical Pain Rating Scale (NPRS) | The NPRS is a tool used to measure the patient's perception of the neck pain on a scale ranging from 0-10 with 10 representing the worst pain possible. | 1 year | 
| Patient Specific Functional Scale (PSFS) | The PSFS is an outcome tool used to assess which particular functional activities are most impacted by their pain. | 1 year | 
| Global Rating of Change Scale (GROC) | The GROC is an outcome tool used independently to measure improvements in a patient's condition or as an anchor for other outcome measures. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck pain, Mechanical Diagnosis and Therapy, Clinical Practice Guidelines