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Completed

NCT Number: NCT06287242

Validation of the Cervicothoracic Differentiation Test

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hartford

West Hartford, Connecticut, 06117, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Manipulation

Other

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

Primary outcomes

  1. pain with motion

    Time frame: immediate post intervention, 7-10 days

    pain occurring with the participants most provocative cervical motion as measured on a 100mm visual analog scale (VAS)

Secondary outcomes

  1. pain at rest

    Time frame: immediate post intervention, 7-10 days

    pain occurring with participant at rest

  2. range of motion

    Time frame: immediate post intervention, 7-10 days

    cervical range of motion as measured with the cervical range of motion device (CROM)

  3. neck disability index

    Time frame: 7-10 days post intervention

    questionnaire assessing disability due to neck pain

Sponsors and collaborators

Lead sponsor

University of Hartford

Other

Registry information

Official study title

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

Acronym: EMU

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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