Neck PainTHSPMOBSNCT02356380
The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
A study testing Mobilization Type in people with Neck Pain, run by Chatham University at 1 site in United States.
Trial summary
To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol. 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?
- Mobilization Type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2018
- 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), cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
- The inclusion and exclusion above represent a conservative approach based on combining criteria of recent studies in published review articles. (Cross, 2011; Walser, 2009
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Chatham University
Pittsburgh, Pennsylvania, 15221
Steve A Karas, DSc, 412-365-2798, skaras@chatham.edu
Steve A Karas, DSc
About this study
To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.
Read the detailed description
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine treatments: grade 1-4 as performed by Cleland et. al. and grade 1-4 mobilization to the thoracic spine as selected by the Physical Therapist for cervical spine pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007) If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Theapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Comission of Accredicdation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.
- Conditions
- Neck Pain
- Being tested
- Mobilization Type
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization TypeOther
Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded.
Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded.
Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae. Receives: Other: Mobilization Type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain
0-10 scale
Measured: 2 weeks
Neck Disability Index
Assessment of function of neck using a valid and reliable written tool.
Measured: 2 weeks
Global Rating of Change
A written scale assessing overall improvement
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 posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356380
- Sponsor's protocol ID
- ChathamU
- Acronym
- THSPMOBS
- Status last verified
- Oct 2017
- First submitted
- 2 Feb 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
- ClinicalTrials.gov ID
- NCT02356380
- Acronym / sponsor ID
- THSPMOBS / ChathamU
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chatham UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Feb 2015 (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.
To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.
Detailed description
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine treatments: grade 1-4 as performed by Cleland et. al. and grade 1-4 mobilization to the thoracic spine as selected by the Physical Therapist for cervical spine pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007) If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Theapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Comission of Accredicdation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: Mobilization TypeGroup One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with Neck Pain
- Ages 18 - 60
Key exclusion criteria (2 listed)
- Red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004), cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
- The inclusion and exclusion above represent a conservative approach based on combining criteria of recent studies in published review articles. (Cross, 2011; Walser, 2009
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 |
|---|---|---|
| Mobilization TypeGroup One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae. | Other | Mobilization |
Primary outcome
Neck Pain
Time frame: 2 weeks
0-10 scale
Neck Disability Index
Time frame: 2 weeks
Assessment of function of neck using a valid and reliable written tool.
Global Rating of Change
Time frame: 2 weeks
A written scale assessing overall improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization Type 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Karas, DSc (412 365 2798, skaras@chatham.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Pain (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 27 Oct 2017.