The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain

The purpose of this research is to compare the effects of two commonly used, safe, thoracic
spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in
individuals with nontraumatic cervical 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)

The subjects will be patients at clinics owned by Physiotherapy Associates, Fit Physical
Therapy, and Allegheny and Chesapeake PT who seek physical therapy services for nontraumatic
neck pain. Participation will be entirely voluntary.

Patients will be offered a chance to participate in the research project on their initial
visit for Physical Therapy.

If the PT identifies an appropriate patient they will ask if they are interested in being a
research subject. The Physical Therapist 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 Commission of Accredidation of Physical Therapy Programs. These techniques are
typically taught in DPT degree programs.

If the patient is interested, a description of the study will be provided. A consent form
will be given to all participants.

Research Procedures:

1. Patients who present to one of three Physical Therapy clinics, under the direction of
three advanced clinicians, will be assessed for their potential participation in this
research. The treating clinician will recruit appropriate subjects based on includion
and exclusion criteria and their PT diagnosis. Those that meet the inclusion and
exclusion criteria will be given the consent form to determine if they wish to
participate. Each researcher will have formal training in these techniques. Two of the
clinicians have received their Orthopedic Clinical Specialists certification under the
examination prcess outlined by the American Physical Therapy association. A third
researcher has obtained his fellowship designation from the American Academy of
Orthopedic Manual Physical Therapy. This skill is deemed entry level by the the
Accredidation Board of the American Physical Therapy Educators. All Therapists will
undergo a prestudy hands on education program to ensure the use of similar techniques.

2. If after reading the consent form they agree to participate, they will be given one
additional form, the Pain Catastrophizing scale, and asked to complete it. The scale,
NDI, cervical ROM, age, and birthdate will be recorded on a sheet contained in the
patient's clinical chart.

3. The PT evaluation will then be completed.

4. They will then be randomized into one of two groups based on a roll of a die:

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 5 mobilization group: this group wil receive a grade 5 mobilization.

5. Additional treatment including patient eduation, modalities, and exercise will be
completed as the PT deems appropriate,

6. The second visit will be scheduled within 24 to 48 hours.

7. The patient will complete the same forms as were completed during the initial
evaluation (NDI, PCS) and return them so that the results may berecorded on the record
sheet identified only with date of birth.

8. The treatment will be repeated including the manual technique and other treatment
deemed appropriate by the PT. Additional treatment between the second and last visits
will be under the sole discretion on the treating PT.

9. On the discharge visit, the patient will receive the same forms, and be asked how much,
in terms of %, they feel they have improved. This information will be recorded on the
deidentified sheet.

Home exercise programs and patient educaiton will be issued as appropriate.

A bubble goniometer will be used for range of motion assessment. This is a standard plastic
device used in PT practice. A Wagner FDX digital force gauge algometer will measure pain
pressure thresholds.

Where survey instruments are involved, a copy of the instrument and, for surveys not created
for this project, assurance that the principal investigator has proper approval to use them.

The Neck Disability Index or NDI will be used. It is the professional standard for outcomes
measures for people with neck pain.

It has been shown to be valid and reliable.

The Pain Castrophizing Scale will be used. It is a valid and reliable measure of a patient's
perception of pain and is commonly used.

The data will be collected by the treating Physical Therapist who has access to the patient
record for treatment purposes.

The data will not be used for purposes other that patient care and research purposes.

Patient's data measures will be collected on a de-identified sheet marked with the patients
birthday. The will be kept in a locked area in the clinic. The lead investigator will have
access to the data when the study is completed and transfer it to a locked file cabinet in
his office for data assessment.

Following treatment the patient may have mild soreness over the area which was treated. This
typically diminishes in 24 hours. the patient will be informed of this potential soreness.
The use of heat and /or ice, exercise, and patient education provided by the Therapist
concerning activities and posture will also lessen the soreness.

INCLUSION CRITERIA:

- Patients with non-traumatic Neck Pain

- Between ages 18 - 60

EXCLUSION CRITERIA:

Red flags such as:

- leg weakness

- night pain

- history of cancer

- upper motor neuron signs

- infection

- tumors

- osteoporosis

- fracture

- history of whiplash within 6 weeks

- cervical stenosis

- CNS involvement

- signs consistent with nerve root compression

- previous surgery

- pending legal action