Validation of the Cervicothoracic Differentiation Test

NCT ID: NCT06287242

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-06-30

Brief 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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

spinal manipulation

Intervention Type: OTHER

High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine

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.

Group Type: ACTIVE_COMPARATOR

spinal manipulation

Intervention Type: OTHER

High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine

Interventions

spinal manipulation

High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hartford

OTHER

Sponsor Role: lead

Responsible Party

Brian Swanson

Principle investigator, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Swanson, PT, DSc

Role: PRINCIPAL_INVESTIGATOR

University of Hartford

Locations

University of Hartford

West Hartford, Connecticut, United States

Countries

United States

Other Identifiers

24-01-282

Identifier Type: -

Identifier Source: org_study_id