Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery
Condition: Cervical Spine Degenerative Disc Disease; Fusion of Spine, Cervical Region
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization
      has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training
      cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to
      be effective in reducing neck pain, restoring cervical spinal function and mobility in many
      types of cervical spine dysfunction. However, the training of stabilizers has not been
      studied in individuals undergoing cervical spinal surgery, even though these individuals
      often have problems with residual pain and weakness after the surgery.

      Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes
      between an early PT intervention and usual care in patients who have undergone anterior
      cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved
      with early PT intervention.

      Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3)
      research design. The patients following ACF surgery will be randomly assigned in one of the
      two treatment groups: usual care and early intervention. Three outcome measures will be
      collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up
      visits, including: (1) deep cervical flexor (DCF) strength as determined by the
      cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated
      neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain
      level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global
      rate of change (GROC) scale will be obtained to determine the patient's perception of overall
      improvement as a result of surgery. The investigator performing the outcome measures will be
      blinded to group assignment, and therefore will not participate in treatment. After
      randomization, the usual care group will receive only one visit of PT for post-operative
      instruction. The early intervention group will receive verbal and written instructions for
      posture and training cervical spine stabilizers in addition to the usual care. The early
      intervention group also will be asked to perform these exercises at home and keep a log of
      the exercise.

      Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences
      in the CCF strength and the NDI scores between groups and at the three different time frames
      with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to
      compare the differences in the NPRS and GROC data over time and between groups.
    

Detailed description: 
      Study Enrollment A research assistant will enroll participants, obtain informed consent, and
      randomly assign participants to the two groups. Therefore, the research assistant will not be
      blinded to group assignment. The primary investigator (PI) will perform all clinical tests,
      and will be blinded to group assignment, and therefore will not perform the PT interventions.
      Three licensed PTs will be trained in both usual care and early PT interventions. The
      research assistant will inform the PT assigned to each study participant of group assignment
      and provide materials for treatment.

      Clinical Examination All participants will undergo a neurological examination for cervical
      spine, including light touch sensory testing, muscle testing, deep tendon reflex testing, and
      neural tension testing of upper extremities in order to identify neurologic deficits. These
      clinical tests will be performed pre-operatively and at 6 and 12 weeks post-operatively.
      During post-operative visits, operative reports and post-operative radiographs will also be
      collected to identify complications from the surgery that may affect the study results, but
      will not be used in determining outcome measures.

      Clinical Outcome Measurements and Instruments

        1. Cranio-cervical Flexor Strength (CCF-S) Testing The CCF-S test will be used to determine
           DCF strength using the StabilizerTM Pressure Biofeedback (Chattanooga Group, Inc,
           Chattanooga, TN) (see Appendix A). The investigator will ask the participants to lie in
           a supine position with knees flexed and the Stabilizer placed under the neck so that it
           supports the cervical spine from just below the occiput to the cervical-thoracic
           junction. The cuff will then be inflated to 20 mm Hg. to support the cervical spine
           without adding anterior forces to the vertebrae. The investigator will instruct the
           participant to do a slight nodding movement, a chin-tuck, producing enough additional
           pressure on the cuff to increase the pressure to 22 mmHg. The participant will be asked
           to hold the pressure at this level for 10 seconds. If they are able to perform this
           successfully, the participant is then asked to try to increase the pressure to 24 mm Hg
           for 10 sec., and if successful, increase to 26 mm. They will proceed in 2 mm increments
           up to a maximum of 30 mmHg. The highest pressure that the participant is able to hold
           for 10 seconds is defined the CCF-S score. The participants will perform the CCF-S test
           twice and the better of two trials will be used for data analysis. The reliability and
           validity of the test has been established on individuals with and without neck pain
           symptoms.

        2. Cranio-cervical Flexor Endurance (CCF-E) Testing The endurance test for the DCF is
           performed by asking the participant to hold the pressure of the CCF-S test for 10
           seconds up to a maximum of 10 repetitions. This test will be stopped on the repetition
           where the participant fails to hold the target pressure on the Stabilizer. Only the
           successful repetitions will be counted, and that number multiplied by ten will be the
           CCF-E score. If the participant is observed to use substitute motions or activate
           superficial neck flexors, they will also be stopped. The CCF-E will be determined with a
           single trial in this study.

        3. Neck Pain Disability Index (Appendix C) The Neck Pain Disability Index (NDI) will be
           used to determine the patient's perceived disability associated with neck pain. The NDI
           is a commonly used scale with 10 items assessing level of neck function. The NDI has
           been shown to be reliable and valid in several studies.

        4. Numeric Pain Rating Scale The Numeric Pain Rating Scale (NPRS) will be used to determine
           the patient's pain level. The NPRS is a well known scale from 0-10 used in many medical
           settings for patients to rate their level of pain.

        5. Global Rating of Change scale The Global Rating of Change (GROC) scale will be used to
           determine the patient's perception of overall improvement. The GROC is a 15-point
           numerical scale from -7 (much worse) through 0 (no change) to +7 (much better), for
           patients to rate the amount of change since surgery. This scale will only be given to
           participants at the two post-operative time frames.

      Intervention The three PTs who will administer physical therapy for the in-patient stay
      following ACF, will be trained to standardize the treatment protocols of both the usual care
      and early PT intervention. After the participant is randomly assigned to one of the two
      groups, the PTs will receive a packet with the materials needed for the assigned group for
      this participant from the research assistant.

        1. Usual Care Group For participants in the usual care group, the intervention will closely
           follow current common practice in the first 6 weeks post-operatively for patients after
           ACF. These participants will be seen in the hospital by one of the two treating PTs
           before discharge. The participants will be instructed the Patient Information Sheet on
           ACF. They will also view the DVD titled "First Six Weeks", a summary of the general post
           spine surgery precautions. The treating PT will address any questions on the video, and
           evaluate the participant for proper positioning of head and neck, use and fit of
           cervical collar if applicable, proper body mechanics, and safety with transfers and
           gait. In the patient instructions for ACF, patients are encouraged to pay attention to
           good posture, and work on walking increasing distances to help the fusion. However, they
           are not given any means of recording or tracking their progress with walking distance.

        2. Early Physical Therapy Intervention Group The participants in the early PT intervention
           group will receive the same instruction as the usual care group. In addition, they will
           be instructed in a series of exercises referred to as "Postural and Neck Protection
           Training" with attention to head positioning and recruiting cervical segmental
           stabilizers, i.e. DCF, and postural muscles. They will be instructed in controlling pain
           that may occur with the exercises. Strategies for pain control will include head and
           shoulder posture correction, position and support of the entire spine such as lumbar
           support, ice application, deep breathing and relaxation techniques. The participants
           will be given specific instructions on exercise and activity with a home exercise log in
           which they can record daily practice of the exercise program and the time spent walking.

      Follow-up calls to all participants will be conducted by a research assistant at 2 and 4
      weeks post surgery to verify compliance with the program and address any questions. Questions
      that require help from the PT will be relayed to the principle investigator (PI) without
      identifying the participant.

      All participants in both groups will also be encouraged to call the assistant with any
      questions throughout the study. Questions will be relayed from the assistant to the PI, so
      that the PI will remain blinded to group assignment.

      Reliability Testing Although the CCF tests have had reliability established for individuals
      with and without neck pain, reliability has not been established for individuals who have
      undergone cervical spine surgery. Therefore, same-day reliability will be tested on the first
      ten participants who are able to complete the CCF-S and CCF-E test at the 6-week
      post-operative data collection. These individuals will perform the CCF-S tests twice, at the
      beginning and the end of their testing session to allow rest in between. Therefore, the CCF
      will be the first outcome measure completed, followed by the other clinical measures. For
      between-day reliability, participants who live in close proximity to the hospital will be
      measured again with a brief return visit for a second time for repeating the CCF tests.
    

Intervention name(s): early physical therapy intervention; usual care
Intervention type(s): Other; Other
Intervention description(s): instruction in home care program to be followed for first six weeks after ACF surgery; one physical therapy visit in hospital following ACF surgery
Other intervention name(s): cervical spine stabilization; posture training; perioperative spine care; post operative spine precautions; perioperative spine care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep cervical flexors; spine stabilization; posture; function; neck pain