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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02356380
Other study ID # ChathamU
Secondary ID
Status Recruiting
Phase N/A
First received February 2, 2015
Last updated October 25, 2017
Start date January 2015
Est. completion date December 2018

Study information

Verified date October 2017
Source Chatham University
Contact Steve Karas, DSc
Phone 412 365 2798
Email skaras@chatham.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients with Neck Pain

- Ages 18 - 60

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobilization Type
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.

Locations

Country Name City State
United States Chatham University Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Chatham University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck Pain 0-10 scale 2 weeks
Primary Neck Disability Index Assessment of function of neck using a valid and reliable written tool. 2 weeks
Primary Global Rating of Change A written scale assessing overall improvement 2 weeks
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