Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery (ACF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519115
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : January 13, 2015
Texas Society of Allied Health Professions
Texas Spine and Joint Hospital
Information provided by (Responsible Party):
cmcfarland, Texas Woman's University

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Spine Degenerative Disc Disease Fusion of Spine, Cervical Region Other: early physical therapy intervention Other: usual care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Clinic Outcomes Between Early Physical Therapy Intervention and Usual Care in Individuals Following Anterior Cervical Fusion
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Usual care
usual care of one physical therapy visit in hospital after ACF surgery
Other: usual care
one physical therapy visit in hospital following ACF surgery
Other Names:
  • post operative spine precautions
  • perioperative spine care

Experimental: Early physical therapy intervention
early physical therapy program instructed and followed at home for 6 weeks
Other: early physical therapy intervention
instruction in home care program to be followed for first six weeks after ACF surgery
Other Names:
  • cervical spine stabilization
  • posture training
  • perioperative spine care

Primary Outcome Measures :
  1. Change in cranio-cervical flexor strength from before surgery to 6 and 12 weeks post operative [ Time Frame: during preo-perative medical exam 1-2 weeks before surgery, and 6 and 12 weeks post ]
    test described in protocol information

Secondary Outcome Measures :
  1. Change in Neck Disability Index from pre-operative condition to 6 and 12 weeks post operative [ Time Frame: during pre-operative medical exam 1-2 weeks before surgery and 6 and 12 weeks post ]
    test described in protocol description

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women between the age of 30 to 70 years
  2. Individuals who have consulted one of the five participating spine surgeons and are scheduled for ACF surgery at Texas Spine and Joint Hospital
  3. Surgical candidates classified as Task Force category III, with neurologic deficit without major structural pathology, or IV, with major structural pathology -

Exclusion Criteria:

  1. Musculoskeletal or systemic disorders with functional impairments that will limit tolerance of testing.
  2. Pain greater than 8/10 on the NPRS that often indicates severe pathology and therefore limits testing tolerance.
  3. Prior cervical spine surgeries.
  4. More than two level cervical spine surgery planned. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519115

United States, Texas
Texas Spine and Joint Hospital
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Texas Woman's University
Texas Society of Allied Health Professions
Texas Spine and Joint Hospital
Study Chair: Sharon Wang, PT, PhD Texas Woman's University
Principal Investigator: Carol McFarland, PT, MS Texas Woman's University

Responsible Party: cmcfarland, Carol McFarland PT, MS, doctoral student, Texas Woman's University Identifier: NCT01519115     History of Changes
Other Study ID Numbers: 16841
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by cmcfarland, Texas Woman's University:
deep cervical flexors
spine stabilization
neck pain

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases