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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Texas Society of Allied Health Professions
Texas Spine and Joint Hospital
Information provided by (Responsible Party):
cmcfarland, Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01519115
First received: January 19, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention
Cervical Spine Degenerative Disc Disease
Fusion of Spine, Cervical Region
Other: early physical therapy intervention
Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    test described in protocol information


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    test described in protocol description


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519115

Locations
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
Investigators
Study Chair: Sharon Wang, PT, PhD Texas Woman's University
Principal Investigator: Carol McFarland, PT, MS Texas Woman's University
  More Information

Publications:
Responsible Party: cmcfarland, Carol McFarland PT, MS, doctoral student, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01519115     History of Changes
Other Study ID Numbers: 16841
Study First Received: January 19, 2012
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014