Validation of the Cervicothoracic Differentiation Test

NCT06287242 | Completed

• 1 other identifier: 24-01-282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

neck pain, manipulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• pain at rest

  immediate post intervention, 7-10 days

• range of motion

  immediate post intervention, 7-10 days

• neck disability index

  7-10 days post intervention

Study Arms (2)

matched manipulation

ACTIVE COMPARATOR

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

unmatched manipulation

ACTIVE COMPARATOR

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

Interventions

spinal manipulation OTHER

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

matched manipulation; unmatched manipulation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Brian Swanson, PT, DSc

  University of Hartford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded research assistants will perform all baseline and follow-up measures. Investigator providing manipulation is blinded to group allocation (matched/unmatched) Participants will not be told if the CTDT indicates that they would benefit from cervical or thoracic manipulation, and the investigator performing the CTDT will only indicate which region is to be manipulated. All investigators are blinded to the work of the others and submit their results to an additional research assistant who will enter the data in a spreadsheet not accessible to the remainder of the research team until the conclusion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, associate professor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: February 20, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)