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NCT01354054 · ClinicalTrials.gov registry record · NA
TENS Effectiveness and Knee Osteoarthritis in Humans
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01354054: Completed NA study, sponsored by University of Iowa.
NCT01354054 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354054, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
TENS is a non pharmacological intervention to control pain. Both high (\>50 Hz) and low (\<10 Hz) frequency TENS are used in the clinic and it is thought that each type works through different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased response to a noxious stimuli, is one component of pain and occurs both at the site of injury, primary hyperalgesia, and outside the site of injury, secondary hyperalgesia. Recent studies in animals with arthritis of the knee show that low and high frequency TENS differentially modulate primary and secondary hyperalgesia. Therefore the investigators hypothesize that TENS will reduce hyperalgesia and pain with movement resulting in increased function.
Primary Outcome
A handheld digital pressure algometer (Somedic AB, Farsta, Sweden), was used to assess PPT with the 1 cm2 circular probe. Pressure was applied at 40 kPa/s and patients were instructed to press the hand held response switch when the sensation first became painful. Familiarization with the proceedure was accomplished with testing on the non-dominant forearm of each subject. Following this familiarization procedure, PPTs were assessed at the knee and anterior tibialis muscle bilaterally. An average
Interventions
- PROCEDURE High Frequency TENS
- PROCEDURE Low frequency TENS
- PROCEDURE Placebo TENS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-06 |
| Phase | NA |
What the finished NCT01354054 record still lists
NCT01354054 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which High Frequency TENS is the first listed.
NCT01354054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354054 about?
NCT01354054 is a clinical study titled "TENS Effectiveness and Knee Osteoarthritis in Humans". TENS is a non pharmacological intervention to control pain. Both high (\>50 Hz) and low (\<10 Hz) frequency TENS are used in the clinic and it is thought that each type works through different mechanisms (see for review Sluka and Walsh, 2003). Hyperalgesia, an increased response to a noxious stimuli...
What is the current status of trial NCT01354054?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2006-11. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01354054?
The interventions under investigation include: High Frequency TENS (PROCEDURE), Low frequency TENS (PROCEDURE), Placebo TENS (PROCEDURE).
Who is sponsoring clinical trial NCT01354054?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354054's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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