Clavicle Splint for Pain Reduction After Posterior Cervicothoracic Surgery
Condition: Posterior Cervical Surgery; Posterior Cervical Fusion; Posterior Cervical Laminectomy; Posterior Cervical Laminoplasty
Study type: Interventional

Summary: 
      The purpose of the study is to see whether a clavicle splint can decrease the pain after
      posterior cervicothoracic surgery. The term "cervicle splint" conveys that the investigators
      do not deal with clavicle fractures here but use the splint he stabilize the posterior
      cervical area. The investigators want to demonstrate this in a prospective randomized manner.
    

Detailed description: 
      In this prospectively controlled randomized study 30 patients who had undergone posterior
      cervical spine surgery were randomized into two groups who either wore or did not wear a
      clavicle brace to retract the shoulders. Patients in the brace group began wearing the brace
      on postoperative day 4, and continuously wore it throughout the 30-day study period. Outcome
      was measured as daily levels of self-reported pain and number of pain pills taken during the
      30-day postoperative period. .

      After hypothesizing a mean pain reduction through the brace on the visual analog scale (VAS)
      for pain from 5 to 3 with a standard deviation of 1, we calculated that at a power level of
      99% and an alpha error of 5%, and given that the VAS numbers were normally distributed, we
      needed 22 patients to enroll into the study. We increased this number to 30 to account for
      early and late dropouts.

      The study was performed at a single institution with patients from 2 different spine
      surgeons.

      Patients were randomized prior to or the day after the procedure to either wear or not wear
      the clavicle brace. Randomization was done through closed envelopes that the patients drew.
      Dissection was performed by the two fellows at our institution and depended solely on the
      number of fused levels and whether or not a tumor had to be removed. Closure was also
      performed by the two spine fellows after instruction by the senior author. Cervical alignment
      was reviewed using the C2-C7 angle according to Cobb's method on lateral images. The
      cervico-thoracic angles were calculated by the addition of the cervical spine angle and the
      remaining angles of thoracic spine until T3 according to Cobb's method.

      The brace was provided by the hospital. Patients were instructed how to properly wear the
      brace by the first author, the senior author, or the hospital Rehabilitation Orthotics
      specialist. To complete the study, patients wore the brace for at least 30 days. (Patients of
      J.P. continued to wear the brace for 3 months outside of the study period.). All patients
      wore hard cervical collars until the end of the study period.

      Patients self-recorded their average level of pain on a scale from 1 to 10 for each
      post-surgery day beginning on postoperative day 2. They also recorded the number of pain
      pills they took each day. On the same sheet used to record medication usage, patients were
      instructed to record each day whether they were able to wear the brace or if they experienced
      problems. At their 1 month postoperative visit the incision was inspected and palpated by the
      first or senior author for the presence of fascial dehiscence and its occurrence was
      recorded.

      Every patient routinely received narcotic and non-narcotic pain medication on an as-needed
      basis in the hospital. No nonsteroidal anti-inflammatory drugs, such as ibuprofen or
      ketorolac, were given. If, on a particular postoperative day, patients were still on an
      intravenous narcotic patient-controlled anesthesia (PCA), that day's data were not recorded
      for the study.
    

Intervention name(s): Clavicle Brace
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment