Clinical Trial: Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparing the Early Use of Cervical/Upper Thoracic Mobilization and Manipulation for Individuals With Mechanical Neck Pain.

Brief Summary: The objective of this pilot study is to determine the feasibility of a large-scale trial. The primary objective is to determine if manipulation applied to the cervical and thoracic spines is more effective than mobilization applied to the cervical and thoracic spines for the management of patients with mechanical neck pain.

Detailed Summary:

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 wi
Sponsor: Youngstown State University

Current Primary Outcome: Change in Neck Disability Index (NDI) [ Time Frame: Initial evaluation, 2nd visit expected average day 3, and discharge expected average 4 weeks. ]

The NDI is a reliable and valid outcome tool for patients with neck pain. It is a self-report measurement tool that was specifically constructed to measure the degree of disability for persons with neck pain. There are 10 total items that are ranked from 0-5 giving a total possible number of 50 points. The larger the score, the greater the disability for that individual.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change in numeric pain rating scale (NPRS) [ Time Frame: initial evaluation, 2nd visit expected average day 3, discharge expected average 4 weeks ]
    The NPRS is used to determine the patient's pain level. The patient is asked to rate their level of pain on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
  • Change in patient specific functional scale (PSFS) [ Time Frame: Initial evaluation, 2nd visit expected average day 3, and at discharge expected average 4 weeks. ]
    The PSFS is a three item questionnaire where the patient is asked to list 3 items they are having difficulty with and rate them on a 0-10 scale with 0 being unable to perform and 10 being able to perform with no limitation.
  • Change in the global rating of change [ Time Frame: after visit 2 (expected average day 3) and again at discharge expected average 4 weeks. ]
    The global rating of change is a 15-point scale where 0 is no change in condition, -7 is a very great deal worse and +7 is a very great deal better. The patient is asked to rate their overall current current condition compared with when they first started care.
  • Percent recovery [ Time Frame: Measured at discharge expected average of 4 weeks into protocol ]
    The patient is asked to rate their overall improvement on a scale of 0% (no better) to 100% completely better
  • Change in deep cervical flexor endurance test [ Time Frame: Initial examination, after 2 visit (expected average day 3) and at discharge ( expected average 4 weeks), ]
    The patient lies in supine and maximally tucks chin to activate the deep cervical flexors. The patient then is asked to lift their head 0.5-1.0 inches off the table and maintain the chin tuck and hold for as long as possible. The investigator times the hold and records when the position cannot be maintained any longer.


Original Secondary Outcome: Same as current

Information By: Youngstown State University

Dates:
Date Received: July 15, 2013
Date Started: July 2013
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016