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

Not Applicable

Not yet recruiting

• Conditions: Neck Pain
• Interventions: Other: Management according to Mechanical Diagnosis and Therapy; Other: Management according to the Cervical Spine Clinical Practice Guidelines

• Registration Number: NCT06160648
• Lead Sponsor: Tufts University

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Study Start: 2024-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical Diagnosis and Therapy (MDT)	Management according to Mechanical Diagnosis and Therapy	MDT is a system of examination and intervention based on the patient's response to repeated end range neck movements.
Cervical Spine Clinical Practice Guidelines (CPGs)	Management according to the Cervical Spine Clinical Practice Guidelines	The CPGs are guidelines for examination and intervention based on a summary of research conducted on people with neck pain.

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	1 year	The NDI is an outcome tool used to measure patient's perceived level of function in relation to their neck pain.

Secondary Outcome Measures

Name	Time	Method
Patient Specific Functional Scale (PSFS)	1 year	The PSFS is an outcome tool used to assess which particular functional activities are most impacted by their pain.
Fear Avoidance Belief Questionnaire (FABQ)	1 year	The FABQ is an outcome tool used to measure a patient's fear in relation to their neck pain.
Numerical Pain Rating Scale (NPRS)	1 year	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.
Global Rating of Change Scale (GROC)	1 year	The GROC is an outcome tool used independently to measure improvements in a patient's condition or as an anchor for other outcome measures.

Trial Locations

Locations (3)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States

WellSpan Health; 🇺🇸 York, Pennsylvania, United States

Good Shepard Penn Partners; 🇺🇸 Radnor, Pennsylvania, United States