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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06160648
• Other study ID #: STUDY00002750
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: Tufts University
• Contact: Ronald Schenk, PhD
• Phone: 716-566-8756
• Email: ronald.schenk[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Management according to Mechanical Diagnosis and Therapy
MDT management is based on the patient response to repeated end range movements.
• Management according to the Cervical Spine Clinical Practice Guidelines
CPG management is based on clinical research regarding management of people with neck pain.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois
United States	Good Shepard Penn Partners	Radnor	Pennsylvania
United States	WellSpan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI)	The NDI is an outcome tool used to measure patient's perceived level of function in relation to their neck pain.	1 year
Secondary	Fear Avoidance Belief Questionnaire (FABQ)	The FABQ is an outcome tool used to measure a patient's fear in relation to their neck pain.	1 year
Secondary	Numerical Pain Rating Scale (NPRS)	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.	1 year
Secondary	Patient Specific Functional Scale (PSFS)	The PSFS is an outcome tool used to assess which particular functional activities are most impacted by their pain.	1 year
Secondary	Global Rating of Change Scale (GROC)	The GROC is an outcome tool used independently to measure improvements in a patient's condition or as an anchor for other outcome measures.	1 year