Clinical trial NCT06160648: The Comparative Effectiveness of Interventions in People With Neck Pain Who Exhibit Directional Preference
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Mechanical Diagnosis and Therapy
Clinical Practice Guidelines
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated to one of two treatment groups.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients aged 18-90 years

Exclusion Criteria:

Patients will be excluded if they:

1. Have a history of spinal surgery
2. Have cervical instability, and/or vertebral basilar insufficiency
3. Have a serious medical condition such as cancer, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis, or other related autoimmune diseases
4. Are currently pregnant
5. Are positive for upper motor neuron signs
6. Are experiencing problems with dizziness, tinnitus, swallowing, or bowel and bladder dysfunction.
7. Do not experience directional preference in the physical therapy initial examination.

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 1 year
Secondary outcomes:
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: 1 year
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 1 year
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 1 year
measure: Global Rating of Change Scale (GROC)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Radnor
country: United States
facility: Good Shepard Penn Partners
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
Study officials:
References: