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Trial Outcomes & Findings for Clavicle Splint for Pain Reduction After Posterior Cervicothoracic Surgery (NCT NCT01977690)

NCT ID: NCT01977690

Last Updated: 2017-08-21

Results Overview

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. 1 Meaning least pain, 10 meaning worst level of pain

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1 month

Results posted on

2017-08-21

Participant Flow

Participant milestones

Participant milestones
Measure
Standard Management
Patients received analgesics ad libitum
Clavicle Brace Wearing
Patient has to wear clavicle brace for one month. Clavicle Brace
Overall Study
STARTED
15
15
Overall Study
COMPLETED
15
11
Overall Study
NOT COMPLETED
0
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Standard Management
Patients received analgesics ad libitum
Clavicle Brace Wearing
Patient has to wear clavicle brace for one month. Clavicle Brace
Overall Study
Withdrawal by Subject
0
4

Baseline Characteristics

Clavicle Splint for Pain Reduction After Posterior Cervicothoracic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Management
n=15 Participants
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.
Clavicle Brace Wearing
n=15 Participants
Patient has to wear clavicle brace for one month. Clavicle Brace
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
55 years
n=5 Participants
57 years
n=7 Participants
56 years
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 4 participants in the Clavicle brace group did not tolerate the brace and are included in the standard management group for this analysis. Only participants will available data are included in the analysis.

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. 1 Meaning least pain, 10 meaning worst level of pain

Outcome measures

Outcome measures
Measure
Standard Management
n=16 Participants
Patients received analgesics ad libitum
Clavicle Brace Wearing
n=11 Participants
Patient has to wear clavicle brace for one month. Clavicle Brace
Average Neck Pain Level
1 units on a scale (VAS pain scale)
Standard Deviation 1
1 units on a scale (VAS pain scale)
Standard Deviation 1

Adverse Events

Standard Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clavicle Brace Wearing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan Duetzmann

Johann Wolfgang Goethe University

Phone: 001491781470479

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place