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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Other: Management according to Mechanical Diagnosis and Therapy; Other: Management according to the Cervical Spine Clinical Practice Guidelines

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
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronald Schenk, PhD; Phone Number: 716-566-8756; Email: ronald.schenk@tufts.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab
      • Contact: Melissa Kolski, DPT; Phone Number: 312-238-7731; Email: mkolski@sralab.org
  • Pennsylvania
    • Radnor, Pennsylvania, United States, 19087
      • Good Shepard Penn Partners
      • Contact: Michael Post, DPT; Phone Number: 607-972-7026; Email: Michael.Post@Pennmedicine.upenn.edu
    • York, Pennsylvania, United States, 17403-3676
      • WellSpan Health
      • Contact: Brian McClenahan, MS PT; Phone Number: 908-601-2025; Email: bmcclen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Management according to Mechanical Diagnosis and Therapy; MDT management is based on the patient response to repeated end range movements.
Active Comparator: 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.	Other: Management according to the Cervical Spine Clinical Practice Guidelines; CPG management is based on clinical research regarding management of people with neck pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Tufts University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Neck pain; Clinical Practice Guidelines; Mechanical Diagnosis and Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: STUDY00002750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No