Clavicle Splint for Pain Reduction After Posterior Cervicothoracic Surgery

NCT ID: NCT01977690

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-08-31

Brief 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.

Conditions

Posterior Cervical Surgery; Posterior Cervical Fusion; Posterior Cervical Laminectomy; Posterior Cervical Laminoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Management

Patients wore no brace.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Clavicle Brace Wearing

Patient has to wear clavicle brace for one month.

Group Type: EXPERIMENTAL

Clavicle Brace

Intervention Type: DEVICE

Interventions

Clavicle Brace

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient underwent cervicothoracic surgery from posterior -

Exclusion Criteria

• Patients that are potentially vulnerable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stephan Duetzmann

M.D.,M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Duetzmann

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Hospital

Stanford, California, United States

Countries

United States

References

Duetzmann S, Cole T, Senft C, Seifert V, Ratliff JK, Park J. Clavicle pain and reduction of incisional and fascial pain after posterior cervical surgery. J Neurosurg Spine. 2015 Dec;23(6):684-9. doi: 10.3171/2015.2.SPINE141118. Epub 2015 Aug 21.

Reference Type: DERIVED

PMID: 26296190 (View on PubMed)

Other Identifiers

CLABRA

Identifier Type: -

Identifier Source: org_study_id