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

NCT06160648 | Unknown

• 1 other identifier: STUDY00002750
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Neck Pain

Keywords

Neck pain; Mechanical Diagnosis and Therapy; Clinical Practice Guidelines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fear Avoidance Belief Questionnaire (FABQ)

  1 year

• Numerical Pain Rating Scale (NPRS)

  1 year

• Patient Specific Functional Scale (PSFS)

  1 year

• Global Rating of Change Scale (GROC)

  1 year

Study Arms (2)

Mechanical Diagnosis and Therapy (MDT)

EXPERIMENTAL

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

Cervical Spine Clinical Practice Guidelines (CPGs)

ACTIVE COMPARATOR

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

Interventions

Management according to Mechanical Diagnosis and Therapy OTHER

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

Mechanical Diagnosis and Therapy (MDT)

Management according to the Cervical Spine Clinical Practice Guidelines OTHER

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

Cervical Spine Clinical Practice Guidelines (CPGs)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients aged 18-90 years

You may not qualify if:

• Patients will be excluded if they:
• Have a history of spinal surgery
• Have cervical instability, and/or vertebral basilar insufficiency
• Have a serious medical condition such as cancer, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis, or other related autoimmune diseases
• Are currently pregnant
• Are positive for upper motor neuron signs
• Are experiencing problems with dizziness, tinnitus, swallowing, or bowel and bladder dysfunction.
• Do not experience directional preference in the physical therapy initial examination.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (3)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Good Shepard Penn Partners

Radnor, Pennsylvania, 19087, United States

Location

WellSpan Health

York, Pennsylvania, 17403-3676, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ronald Schenk, PhD

CONTACT

716-566-8756; ronald.schenk@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator and the participants are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants are randomly allocated to one of two treatment groups.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

US (3)