Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain

All potential subjects will be assessed for eligibility prior to signing the informed
consent by filling out a demographic questionnaire and through a subjective interview that
will include a health history examination performed by a physical therapist that has
received additional training in orthopedic manual therapy. A physical therapist (PT) is a
highly educated licensed health care professional that has graduated from an accredited
university and has passed a national licensure exam. Physical therapists specialize in
movement disorders and are well trained in the examination and treatment for primary and
secondary medical conditions pertaining to the cardiovascular, neuromuscular,
musculoskeletal, and integumentary body systems. Manual therapy interventions for the neck
and thoracic spine including manipulations are taught in entry-level physical therapy
programs. Continuing education courses are available for physical therapists to get advanced
training in manual therapy. This training involves not only improving the skill set of the
therapist but also focuses on enhancing the knowledge of the therapist concerning the safety
of patients. Each of the treating therapists will have certifications in manual therapy.
Screening for inclusion and exclusion criteria will be done by the treating PT by means of
assessing subjective outcomes, patient demographic, and through their subjective history
examine. Subjects will then be given the informed consent to be read and signed if they
agree to participate. Subjects will be permitted to ask any questions relative to any study
procedures they do not understand. Two physical therapists at each facility will be used in
order to keep the outcome measures blinded. The treating therapist or clinic PT will perform
the examination/evaluation and perform all manual therapy treatments during the first 2
visits of care. Pending there are no scheduling conflicts; the treating therapist will
continue to provide the treatment. If there is a scheduling conflict, another physical
therapist will provide the patient's care until the next available opening on the treating
therapist. The recording therapist, or research therapist, will record all the dependent
variables and will remain blinded to group allocation. This is the only assignment given to
the research therapist. The treating therapist will be blinded to all results of the outcome
data except in the case where data is needed for clinical decision making in order to
optimize patient outcomes. After informed consent is attained, outcome data will then be
collected by the recording physical therapist that is not aware of group allocation. The
data collected will include the neck disability index (NDI), patient specific functional
score (PSFS), numeric pain rating scale (NPRS), deep cervical flexion test (DCF), cervical
range of motion (CROM) using a CROM, therapist equipoise, and patient preference. Following
initial data collection, each subject will be randomized via concealed allocation to receive
either mobilization or manipulation directed to the cervical and upper thoracic spine for
the first two treatment visits. The patient will be treated on day 1 with their randomized
treatment technique. The manual technique chosen for treatment by each clinician will be
determined by the results of their physical examination. Other interventions included for
both groups will include a standardized exercise program and advice, encouragement, and
assurance. Immediately following the treatment procedures, data will be collected again and
will include the NPRS, global rating of changes (GROC), cervical range of motion, and DCF.
The therapist will determine the next appropriate follow-up visit. Data will again be
collected at the beginning of the 2nd visit follow-up and will include NPRS, GROC, cervical
range of motion, DCF, PSFS, and NDI by the blinded physical therapist. Treatments of
cervical and thoracic mobilization or manipulation will occur again based on group
allocation established prior. The technique used by the treating clinician will be based on
their assessment of the patient and again will follow group allocation. After the 2nd visit
(day 3), the treating physical therapist is able to add or remove treatments, as they deem
necessary to improve the patient's condition. Orthopedic manual therapy (mobilization or
manipulation) may be adjusted based on patient need as well. Subsequent visits and plan of
care will continue under the direction of the physical therapist based on the patient's
need. Final data collection performed at discharge will include the NDI, PSFS, GROC, and
total number of visits, patient satisfaction, therapist equipoise, and total days of care.

Analysis: Baseline characteristics of all subjects will be compared using either a t-test or
chi square as appropriate. A two way multivariate analysis of variance (MANOVA) will be used
to compare outcomes of NDI, PSFS, and NPRS at baseline, at day 3, and at day 30.

Inclusion Criteria:

- subjects aged 18-70 years old with a chief complaint of reproducible neck pain and an
NDI score of 10 or greater.

Exclusion Criteria:

- Subjects are excluded if they have had recent whiplash or significant trauma,
demonstrate red flag items such as malignancy, radiculopathy, myelopathy, fracture,
metabolic disease, rheumatoid arthritis, long-term steroid use, or history of neck
surgery. Additional exclusion criteria including neck pain of <2 on the NPRS, PSFS ≤
8, no prior treatment within 6 weeks time, upper limb symptoms, or any pending
litigation. Finally, if a therapist determines the patient has a neck condition that
is highly irritable where the manipulation is not appropriate, they will be excluded.