Validation of the Cervicothoracic Differentiation Test (EMU)

Effectiveness of Matched or Unmatched Cervical and Thoracic Manipulations on Neck Pain: A Randomized Clinical Trial Involving the CTDT (The EMU Manipulation Study)

The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:

• rate their pain with neck movement, complete brief questionnaires about their pain,
• have their neck range of motion measured,
• perform a test known as the cervico-thoracic differentiation test (CTDT),
• receive either a cervical or thoracic manipulation,
• repeat the range of motion measurements.
• A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.

Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Other: spinal manipulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Swanson, PT, DSc; Phone Number: 8607685314; Email: bswanson@hartford.edu

Study Locations

• United States
  • Connecticut
    • West Hartford, Connecticut, United States, 06117
      • Recruiting
      • University of Hartford
      • Contact: Brian Swanson, PT, DSc; Phone Number: 860-768-5314; Email: bswanson@hartford.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• between the ages of 18 and 65,
• must report neck pain with a Visual Analogue Scale (VAS) greater than or equal to 3/10.

Exclusion Criteria:

• History of motor vehicle accident (MVA) within the past 6 months,
• hypertension greater than or equal to 160/100,
• non-mechanical neck pain (pain that is not reproducible with movement),
• any past or present history of cancer,
• upper motor neuron (CNS) lesion symptoms ( a positive Clonus sign, Babinski sign, or hyperreflexia of DTR's),
• any infection that originates from the spine
• Current confirmed or suspected pregnancy, or recent postpartum (6 mos),
• known osteoporosis,
• rheumatoid arthritis,
• long-term use of corticosteroids (>6mos),
• history of neck surgery,
• history of vertebral or rib fractures,
• blood clotting disorders,
• connective tissue disorders,
• radicular/neural pain/symptoms. Radicular pain and symptoms would include dermatomal changes (sensory loss or hypersensitization), myotomal changes (weaknesses of muscular along nerve distributions), decreased reflexes (hyporeflexia), pain that travels down the upper extremities, and pain that is referred into the upper extremities.
• clinical signs of instability of the vertebral segments in their neck

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: matched manipulation; For the matched manipulation group, participants with the source of neck pain at the cervical spine determined by the CTDT will receive a cervical manipulation, and participants with the source of neck pain at the thoracic spine determined by the CTDT will receive a thoracic manipulation. The manipulation will be given to the participant's most provocative spinal level as determined by the examiner and side determined by the CTDT. The investigator will be limited to 2 manipulation attempts even if cavitation was not achieved.	Other: spinal manipulation; High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine
Active Comparator: unmatched manipulation; For the unmatched manipulation group, participants with the source of neck pain at the cervical spine determined by the CTDT will receive a thoracic manipulation, and participants with the source of neck pain at the thoracic spine found during the CTDT will receive a cervical manipulation. The manipulation will be given to the most hypomobile spinal level determined by the physical therapist and to the most provocative side found during the CTDT. The investigator will be limited to 2 manipulation attempts even if cavitation was not achieved.	Other: spinal manipulation; High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain with motion	pain occurring with the participants most provocative cervical motion as measured on a 100mm visual analog scale (VAS)	immediate post intervention, 7-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain at rest	pain occurring with participant at rest	immediate post intervention, 7-10 days
range of motion	cervical range of motion as measured with the cervical range of motion device (CROM)	immediate post intervention, 7-10 days
neck disability index	questionnaire assessing disability due to neck pain	7-10 days post intervention

Collaborators and Investigators

• Sponsor: University of Hartford
• Investigators: Principal Investigator: Brian Swanson, PT, DSc, University of Hartford

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: neck pain, manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 24-01-282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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