TriangleNCT01194466 · OUTCOME
Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- change units on a VAS scale
- Interval / dispersion
- Standard Deviation
- Time frame
- The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions
What was measured
Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.
Analysis population: The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.
Groups in this outcome
Active TENS
Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.
Placebo TENS
Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.
No TENS
Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.
| Group | Source count |
|---|---|
| Active TENS | 40 |
| Placebo TENS | 40 |
| No TENS | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active TENS | -1.4 | 1.3 | Not reported | Not reported | Not reported |
| Placebo TENS | -0.6 | 1.1 | Not reported | Not reported | Not reported |
| No TENS | 0.1 | 0.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.3
- value
- -1.4
- group Id
- OG001
- spread
- 1.1
- value
- -0.6
- group Id
- OG002
- spread
- 0.9
- value
- 0.1
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 40
- units
- Participants
- description
- Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.
- dispersion Type
- Standard Deviation
- groups
- description
- Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.
- id
- OG000
- title
- Active TENS
- description
- Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.
- id
- OG001
- title
- Placebo TENS
- description
- Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.
- id
- OG002
- title
- No TENS
- param Type
- MEAN
- population Description
- The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.
- reporting Status
- POSTED
- time Frame
- The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions
- title
- Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)
- type
- PRIMARY
- unit Of Measure
- change units on a VAS scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice