Trial Outcomes & Findings for Effects of TENS Therapy Following Arthroscopic Knee Surgery (NCT NCT01528228)
NCT ID: NCT01528228
Last Updated: 2019-01-11
Results Overview
The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Two weeks postoperatively.
Results posted on
2019-01-11
Participant Flow
Participant milestones
| Measure |
Structured TENS Therapy
This group will be given an active TENS unit to use.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
Sham TENS Therapy
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of TENS Therapy Following Arthroscopic Knee Surgery
Baseline characteristics by cohort
| Measure |
Structured TENS Therapy
n=10 Participants
This group will be given an active TENS unit to use.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
Sham TENS Therapy
n=10 Participants
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
53.3 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
50.0 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two weeks postoperatively.The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain
Outcome measures
| Measure |
Structured TENS Therapy
n=9 Participants
This group will be given an active TENS unit to use.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
Sham TENS Therapy
n=9 Participants
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
|
|---|---|---|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 0
|
5.10 score on 0-10 pain level scale
Interval 3.16 to 7.04
|
5.24 score on 0-10 pain level scale
Interval 3.25 to 7.22
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 1
|
4.68 score on 0-10 pain level scale
Interval 2.81 to 6.56
|
4.07 score on 0-10 pain level scale
Interval 2.19 to 5.95
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 2
|
3.41 score on 0-10 pain level scale
Interval 1.54 to 5.28
|
3.28 score on 0-10 pain level scale
Interval 1.41 to 5.15
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 3
|
2.78 score on 0-10 pain level scale
Interval 0.91 to 4.66
|
2.95 score on 0-10 pain level scale
Interval 1.09 to 4.82
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 4
|
2.49 score on 0-10 pain level scale
Interval 0.62 to 4.37
|
3.22 score on 0-10 pain level scale
Interval 1.36 to 5.09
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 5
|
3.00 score on 0-10 pain level scale
Interval 1.13 to 4.88
|
3.26 score on 0-10 pain level scale
Interval 1.4 to 5.13
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 6
|
2.20 score on 0-10 pain level scale
Interval 0.33 to 4.07
|
2.72 score on 0-10 pain level scale
Interval 0.85 to 4.59
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 7
|
2.42 score on 0-10 pain level scale
Interval 0.55 to 4.29
|
2.78 score on 0-10 pain level scale
Interval 0.92 to 4.65
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 8
|
3.12 score on 0-10 pain level scale
Interval 1.25 to 5.0
|
2.63 score on 0-10 pain level scale
Interval 0.77 to 4.5
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 9
|
2.59 score on 0-10 pain level scale
Interval 0.72 to 4.46
|
2.35 score on 0-10 pain level scale
Interval 0.48 to 4.21
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 10
|
2.85 score on 0-10 pain level scale
Interval 0.97 to 4.72
|
2.30 score on 0-10 pain level scale
Interval 0.44 to 4.17
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 11
|
2.62 score on 0-10 pain level scale
Interval 0.75 to 4.49
|
2.93 score on 0-10 pain level scale
Interval 1.06 to 4.79
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 12
|
2.50 score on 0-10 pain level scale
Interval 0.62 to 4.37
|
2.66 score on 0-10 pain level scale
Interval 0.78 to 4.54
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 13
|
2.42 score on 0-10 pain level scale
Interval 0.53 to 4.31
|
3.02 score on 0-10 pain level scale
Interval 1.13 to 4.91
|
|
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Day 14
|
2.33 score on 0-10 pain level scale
Interval 0.41 to 4.25
|
3.20 score on 0-10 pain level scale
Interval 1.27 to 5.13
|
Adverse Events
Structured TENS Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TENS Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place