Trial Outcomes & Findings for The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy (NCT NCT02012686)

NCT ID: NCT02012686

Last Updated: 2014-06-11

Results Overview

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 0.5 hours after thyroidectomy
• Results posted on: 2014-06-11

Participant Flow

Participant milestones

Measure	Control Group numerical rating scale of TENS non-applied group	TENS Group numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Overall Study STARTED	50	50
Overall Study COMPLETED	50	48
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Control Group numerical rating scale of TENS non-applied group	TENS Group numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Overall Study muscle contraction	0	1
Overall Study electrocardiography monitoring noise	0	1

Baseline Characteristics

The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy

Baseline characteristics by cohort

Measure	Control Group n=50 Participants numerical rating scale of TENS non-applied group	TENS Group n=48 Participants numerical rating scale of TENS applied group	Total n=98 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 10 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=7 Participants	44 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	50 participants n=5 Participants	48 participants n=7 Participants	98 participants n=5 Participants
Body mass index	23 kg/m^2 STANDARD_DEVIATION 3 • n=5 Participants	23 kg/m^2 STANDARD_DEVIATION 3 • n=7 Participants	23 kg/m^2 STANDARD_DEVIATION 3 • n=5 Participants
Neck extension time	80 minutes STANDARD_DEVIATION 25 • n=5 Participants	81 minutes STANDARD_DEVIATION 31 • n=7 Participants	80 minutes STANDARD_DEVIATION 28 • n=5 Participants

PRIMARY outcome

Timeframe: 0.5 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Outcome measures

Measure	Control Group n=50 Participants numerical rating scale of TENS non-applied group	TENS Group n=48 Participants numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy Inter-Quatile Range	3.5 scores on a scale Interval 1.0 to 5.0	0 scores on a scale Interval 0.0 to 2.0
Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy Full Range	3.5 scores on a scale Interval 0.0 to 10.0	0 scores on a scale Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: 6 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Outcome measures

Measure	Control Group n=50 Participants numerical rating scale of TENS non-applied group	TENS Group n=48 Participants numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy Full Range	4 scores on a scale Interval 0.0 to 8.0	2 scores on a scale Interval 0.0 to 8.0
Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy Inter-Quatile Range	4 scores on a scale Interval 3.0 to 5.0	2 scores on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 24 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Outcome measures

Measure	Control Group n=50 Participants numerical rating scale of TENS non-applied group	TENS Group n=48 Participants numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy Inter-Quatile Range	3 scores on a scale Interval 2.0 to 4.0	1 scores on a scale Interval 0.0 to 3.0
Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy Full Range	3 scores on a scale Interval 0.0 to 6.0	1 scores on a scale Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 48 hours after thyroidectomy

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Outcome measures

Measure	Control Group n=50 Participants numerical rating scale of TENS non-applied group	TENS Group n=48 Participants numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation
Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy Inter-Quatile Range	2 scores on a scale Interval 0.0 to 4.0	0 scores on a scale Interval 0.0 to 2.0
Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy Full Range	2 scores on a scale Interval 0.0 to 5.0	0 scores on a scale Interval 0.0 to 6.0

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TENS Group

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

Dr Dong Woo Han

Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea

Phone: 82-2-2019-3549

Email: HANESTH@yuhs.ac

Results disclosure agreements

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