Neck PainNCT01917071
The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain
A study testing thoracic spine manipulation in people with Neck Pain, run by Chatham University at 1 site in United States.
Trial summary
Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain. Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- thoracic spine manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Neck Pain; ages 18 - 60
Who cannot join
- red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Directional Specific Thoracic Spine Mobilization on Cervial Spine Pain.
Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain.
Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. This study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.
Read the detailed description
Manipulation of the thoracic spine is the most commonly used manual therapy intervention by manual therapists. It is not known whether we can accurately assess and treat directional limitations in the thoracic spine to improve neck pain.
One way is to assess where the limitation is and treat it. Another method is to distract the joint. We want to know if matching the limitation to the manipulation method will give patients with neck pain better results.
The patient lays on their back. The therapist places a hand on the inferior vertebrae of the motion segment. The patient relaxes and the therapist pushes in an anterior to posterior direction either moving the vertebrae into flexion or entension.
- Conditions
- Neck Pain
- Being tested
- thoracic spine 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.
thoracic spine manipulationOther
a manual technique applied to the mid back to promote motion
| Study group | Role | What they receive |
|---|---|---|
| Matched Group | Experimental | Receives thoracic spine manipulation in the direction of motion limitation. Receives: Other: thoracic spine manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Objective, valid, reliable measure of function in patients with neck pain. Completed as a survey.
Measured: 2 weeks
Secondary outcomes (1)
Neck Pain
Selection of 0 to 10 level of pain.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chatham University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Karas, Chatham University
- Investigators
- Steve A Karas, DSc, PT, Study director, Chatham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917071
- Sponsor's protocol ID
- Karasmatched
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Directional Specific Thoracic Spine Mobilization on Cervial Spine Pain.
- ClinicalTrials.gov ID
- NCT01917071
- Acronym / sponsor ID
- Karasmatched
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chatham UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Aug 2013 (estimated)
- 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.
Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain.
Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. This study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.
Detailed description
Manipulation of the thoracic spine is the most commonly used manual therapy intervention by manual therapists. It is not known whether we can accurately assess and treat directional limitations in the thoracic spine to improve neck pain.
One way is to assess where the limitation is and treat it. Another method is to distract the joint. We want to know if matching the limitation to the manipulation method will give patients with neck pain better results.
The patient lays on their back. The therapist places a hand on the inferior vertebrae of the motion segment. The patient relaxes and the therapist pushes in an anterior to posterior direction either moving the vertebrae into flexion or entension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matched Group | Experimental | Other: thoracic spine manipulationReceives thoracic spine manipulation in the direction of motion limitation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with Neck Pain; ages 18 - 60
Key exclusion criteria (1 listed)
- red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
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 |
|---|---|---|
| thoracic spine manipulationa manual technique applied to the mid back to promote motion | Other | Matched Group |
Primary outcome
Neck Disability Index
Time frame: 2 weeks
Objective, valid, reliable measure of function in patients with neck pain. Completed as a survey.
1 secondary outcome
Neck Pain
Time frame: 2 weeks
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 28 Jul 2015.
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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.
Steve A Karas, DSc, PT study director
Chatham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic spine manipulation in people with Neck Pain, run by Chatham University 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 1 inclusion and 1 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 28 Jul 2015. 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?
Neck Disability Index (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2015.