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

NCT ID: NCT06160648

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-01

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.

Conditions

Neck Pain

Keywords

Neck pain; Mechanical Diagnosis and Therapy; Clinical Practice Guidelines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mechanical Diagnosis and Therapy (MDT)

MDT is a system of examination and intervention based on the patient's response to repeated end range neck movements.

Group Type: EXPERIMENTAL

Management according to Mechanical Diagnosis and Therapy

Intervention Type: OTHER

MDT management is based on the patient response to repeated end range movements.

Cervical Spine Clinical Practice Guidelines (CPGs)

The CPGs are guidelines for examination and intervention based on a summary of research conducted on people with neck pain.

Group Type: ACTIVE_COMPARATOR

Management according to the Cervical Spine Clinical Practice Guidelines

Intervention Type: OTHER

CPG management is based on clinical research regarding management of people with neck pain.

Interventions

Management according to Mechanical Diagnosis and Therapy

MDT management is based on the patient response to repeated end range movements.

Intervention Type: OTHER

Management according to the Cervical Spine Clinical Practice Guidelines

CPG management is based on clinical research regarding management of people with neck pain.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Ronald Schenk

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Good Shepard Penn Partners

Radnor, Pennsylvania, United States

WellSpan Health

York, Pennsylvania, United States

Countries

United States

Central Contacts

Ronald Schenk, PhD

Role: CONTACT

Phone: 716-566-8756

Email: ronald.schenk@tufts.edu

Facility Contacts

Melissa Kolski, DPT

Role: primary

Michael Post, DPT

Role: primary

Brian McClenahan, MS PT

Role: primary

Other Identifiers

STUDY00002750

Identifier Type: -

Identifier Source: org_study_id