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ClinicalTrials.gov ID

NCT06160648

Lead Sponsor

Tufts UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Dec 7, 2023Actual

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jul 1, 2025Estimated

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

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.

• Neck Pain

• Management according to Mechanical Diagnosis and Therapy
• Management according to the Cervical Spine Clinical Practice Guidelines

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Tufts UniversityOTHER

bmcclen@gmail.com908-601-2025