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NCT06160648 | NOT YET RECRUITING | Neck Pain

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

Tufts University

Information provided by (Responsible Party):

Ronald Schenk

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.

Condition or disease

Neck Pain

Intervention/treatment

Management according to Mechanical Diagnosis and Therapy

Management according to the Cervical Spine Clinical Practice Guidelines

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : TRIPLE
Masking Description : The primary investigator and the participants are masked.
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-01-01
Estimated Primary Completion Date : 2025-01-01
Estimated Study Completion Date : 2025-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Comparative Effectiveness of Interventions in People With Neck Pain Who Exhibit Directional Preference

Location Details

NCT06160648

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Locations

Not yet recruiting

United States, Illinois

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Pennsylvania

Good Shepard Penn Partners

Permanent, Pennsylvania, United States, 19087

Not yet recruiting

United States, Pennsylvania

WellSpan Health

York, Pennsylvania, United States, 17403-3676