Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): Cervical and thoracic mobilization; cervical and thoracic manipulation
Intervention type(s): Other; Other
Intervention description(s): Described in arm description; described in arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain, orthopedic manual therapy