Neck PainEMUNCT06287242
Validation of the Cervicothoracic Differentiation Test
A study testing spinal manipulation in people with Neck Pain, run by University of Hartford at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- spinal manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 65,
- must report neck pain with a Visual Analogue Scale (VAS) greater than or equal to 3/10.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
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)
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
- Being tested
- spinal manipulation
- Keywords
- neck pain, manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulationOther
High velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain with motion
pain occurring with the participants most provocative cervical motion as measured on a 100mm visual analog scale (VAS)
Measured: immediate post intervention, 7-10 days
Secondary outcomes (3)
pain at rest
pain occurring with participant at rest
Measured: immediate post intervention, 7-10 days
range of motion
cervical range of motion as measured with the cervical range of motion device (CROM)
Measured: immediate post intervention, 7-10 days
neck disability index
questionnaire assessing disability due to neck pain
Measured: 7-10 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start20 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Swanson, University of Hartford
- Investigators
- Brian Swanson, PT, DSc, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287242
- Sponsor's protocol ID
- 24-01-282
- Acronym
- EMU
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swanson BT, Cimen M, DiMercurio CD, Dunne AG, Dunne MS, Hubbard C, Kirck BC, Nadeau RM, Artzer P. The EMU manipulation study: A randomized trial investigating the efficacy of matched or unmatched cervical/thoracic manipulations on neck pain. Musculoskelet Sci Pract. 2025 Oct;79:103382. doi: 10.1016/j.msksp.2025.103382. Epub 2025 Jul 2.
PubMed 40618509
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06287242
- Acronym / sponsor ID
- EMU / 24-01-282
- Conditions
- Neck Pain
- Keywords
- neck pain, manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| matched manipulation | Active comparator | Other: spinal manipulationFor 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. |
| unmatched manipulation | Active comparator | Other: spinal manipulationFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between the ages of 18 and 65,
- must report neck pain with a Visual Analogue Scale (VAS) greater than or equal to 3/10.
Key exclusion criteria (16 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal manipulationHigh velocity, low amplitude (HVLA) manipulation of the cervical or thoracic spine | Other | matched manipulation, unmatched manipulation |
Primary outcome
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)
3 secondary outcomes
pain at rest
Time frame: immediate post intervention, 7-10 days
range of motion
Time frame: immediate post intervention, 7-10 days
neck disability index
Time frame: 7-10 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40618509Swanson BT, Cimen M, DiMercurio CD, Dunne AG, Dunne MS, Hubbard C, Kirck BC, Nadeau RM, Artzer P. The EMU manipulation study: A randomized trial investigating the efficacy of matched or unmatched cervical/thoracic manipulations on neck pain. Musculoskelet Sci Pract. 2025 Oct;79:103382. doi: 10.1016/j.msksp.2025.103382. Epub 2025 Jul 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Swanson, PT, DSc principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal manipulation in people with Neck Pain, run by University of Hartford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain with motion (time frame: immediate post intervention, 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.