Validation of the Cervicothoracic Differentiation Test

Neck Pain Clinical Trial

— EMU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287242
• Other study ID #: 24-01-282
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: University of Hartford
• Contact: Brian Swanson, PT, DSc
• Phone: 8607685314
• Email: bswanson[@]hartford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• spinal manipulation
High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine

Locations

Country	Name	City	State
United States	University of Hartford	West Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Hartford

Country where clinical trial is conducted

United States, 

Outcome

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