Early Self-Directed Home Exercise Program After Anterior Cervical Discectomy and Fusion

A Pilot Study

Rogelio A. Coronado, PT, PhD; Clinton J. Devin, MD; Jacquelyn S. Pennings, PhD; Susan W. Vanston, PT, MS; Dana E. Fenster, BS; Jeffrey M. Hills, MD; Oran S. Aaronson, MD; Jacob P. Schwarz, MD; Byron F. Stephens, MD; Kristin R. Archer, PhD, DPT

Disclosures

Spine. 2020;45(4):217-225. 

In This Article

Methods

Study Design

This study was a single-blind pilot randomized controlled trial. Data were assessed preoperatively and 6 weeks, 6 months, and 12 months after surgery. The Institutional Review Board at Vanderbilt University Medical Center approved this study. The trial protocol was published on ClinicalTrials.gov (NCT02720172). Trial conduct and reporting were in accordance with CONSORT.[23,24]

Procedures

Consecutive patients were screened from April 2016 to July 2017. The inclusion criteria were patients aged 21 years and older; English-speaking; and undergoing ACDF for cervical stenosis, spondylosis, degenerative spondylolisthesis, or disc herniation. Exclusion criteria were patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity; undergoing cervical corpectomy; with a worker's compensation claim; diagnosed with severe psychiatric disorder such as schizophrenia or other psychotic disorder; with a documented history of alcohol and/or drug abuse; and unable to return to clinic for follow-up visits or provide a stable telephone or physical address.

Enrolled participants provided written informed consent and completed a preoperative assessment containing demographic and clinical characteristics, and validated outcome measures for disability, pain, and physical and mental health. Medical record data included baseline information on prior neck surgery, comorbidities (Functional Comorbidity Index),[25] surgical indication, and number of fusion levels, and surgeon instructions at hospital discharge. Randomization to early self-directed HEP or usual care was conducted in a concealed manner by personnel not responsible for recruitment using a computer-generated scheme in a 1:1 ratio in blocks of assignments stratified by age (21–59; 60–90) and number of fusion levels (1 or 2; 3 or more). After the intervention (6 weeks) and at 6 and 12 months after surgery, participants completed the validated outcome measures and answered questions about opioid use, physical therapy (PT) utilization, and revision surgery. Questionnaires were completed remotely by participants through paper or Web-based survey (Research electronic data capture: REDCap[26]) or in-person at a 6- or 12-month clinic visit. Medical records were reviewed for revision status at 18 to 24 months after surgery. All outcomes were assessed by study personnel blinded to group assignment.

Intervention

Early Home Exercise Program. Participants received usual postoperative care plus a self-directed HEP to decrease pain and promote movement and activity during the initial 6-week recovery period (Table 1).[27] The HEP included daily walking and sleeping instructions, and range of motion and strengthening exercises. Cognitive-behavioral strategies based on the work by Archer et al[28] in patients undergoing lumbar spine surgery included relaxation, deep breathing, and distraction. Specific therapeutic exercises included (1) neck range of motion (limited to approximately 30° in all directions); (2) shoulder (i.e., shrugs, scapular retraction, circles) and upper back range of motion; and (3) neck (i.e., isometrics, chin tuck), shoulder (i.e., theraband flexion, internal/external rotation, wall push-up), and core/trunk strengthening (i.e., abdominal tightening with extremity movements) (Appendix 1, http://links.lww.com/BRS/B466). Therapeutic exercises were progressed in difficulty over three 2-week phases as participants tolerated and as directed by a licensed physical therapist (S.W.V.) over weekly phone calls. In addition to progressing exercise, the therapist tracked patient adherence and documented adverse events. Participants were provided a manual for the HEP program and completed an HEP diary to record days performing exercise. Before the current randomized trial, the early HEP protocol was tested in eight participants to assess feasibility.[29] Refinement of the program included the addition of sleeping tips.

Usual Care. Patients received usual postoperative care from their surgeon. Usual care included medication, cervical collar as indicated, and driving or lifting restrictions. Referral to PT was typically ordered at the 6-week postoperative visit.

Acceptability

Acceptability was assessed through adherence and an intervention assessment at 6 weeks. Participants were asked to rate the helpfulness of the program and the likelihood of recommending the program to a friend using an 11-point numeric rating scale (NRS) with 0 meaning "not at all helpful or likely" and 10 "extremely helpful or likely." Participants were asked to rate the overall benefit considering the effort put into it, and the importance of changes in pain and activity using a 5-point Likert scale. Open-ended questions were asked regarding ideal start time.

Safety

Safety was determined through adverse events, imaging, and revision surgery at 12 months. Adverse events were recorded weekly during the intervention phase. Fusion status was determined by review of postoperative computed tomography when available,[30] or by interspinous motion analysis on dynamic flexion-extension radiographs as described by Song et al.[31] All radiographs were assessed by a single evaluator (J.M.H.) blinded to group assignment. Images were obtained at routine clinic visits at the discretion of the surgeon. Revision surgery was determined at 18 to 24 months via patient self-report and electronic medical record review.

Outcomes

Outcomes included disability, pain, general health, and opioid utilization. Disability was assessed with the 10-item Neck Disability Index (NDI).[32] The NDI has demonstrated good to excellent psychometric properties in patients undergoing cervical spine fusion.[33] The minimum clinically important difference (MCID) for the NDI is 7.5 points in patients after ACDF.[33] Neck and arm pain intensity were assessed with an 11-point NRS.[34] The NRS is a reliable and valid measure of pain intensity in older adults and patients with chronic pain.[35,36] The MCID for the NRS is 2.6 points in patients after ACDF.[37] Physical and mental health was assessed with the SF-12.[38] The SF-12 is a reliable and valid measure of general health.[39,40] The MCID for the SF-12 physical health subscale is 8.1 points and for the mental health subscale is 4.7 points in patients after ACDF.[41] Opioid utilization was assessed with the question "are you currently taking opioid medications" at 6 weeks, and 6 and 12 months.

Statistical Analysis

Baseline comparisons were assessed with t tests or Fisher exact tests. The primary analyses were intent-to-treat. Change scores with 95% confidence intervals (CIs) were computed for each group. Separate multivariable linear regression analyses were performed to determine the independent impact of early HEP compared to usual care on each outcome at 6 weeks, 6 months, and 12 months. Covariates included the baseline outcome score and number of comorbidities. Regression output was interpreted based on significance level, beta value, and 95% CI. Alpha was set at an a priori level of 0.05 for statistical significance.

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