Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee (TENSSENS)
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|ClinicalTrials.gov Identifier: NCT01390285|
Recruitment Status : Unknown
Verified April 2011 by Vrije Universiteit Brussel.
Recruitment status was: Not yet recruiting
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Central sensitization has recently been documented in patients with knee osteoarthritis. So far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee.
First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to explore the prognostic value of central sensitization on the pain inhibitory effect of TENS in Oak patients.
Patients with knee pain due to OAk will be recruited through advertisements in local media. Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and function will be assessed. Patients will be randomly allocated to one of two treatment groups (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and 12 weeks.
TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous fibers. The responsiveness of central pain-signaling neurons of OAk patients who are centrally sensitized may be augmented to the input of these electrical stimuli. This would encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit from burst TENS.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Transcutaneous electric nerve stimulation Device: sham transcutaneous electrical nerve stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Patients With Osteoarthritis of the Knee: a Randomized Controlled Clinical Trial.|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2014|
Device: Transcutaneous electric nerve stimulation
The subjects that enter the TENS-group will be asked to apply the TENS therapy for at least 40 minutes continuously per day. The parameters of the current will not be changed during the study (pulse: 250 µsec; internal frequency: 100Hz; burst frequency 3 Hz; intensity: until an unpleasant but not painful sensation is acquired).
|Sham Comparator: Sham TENS||
Device: sham transcutaneous electrical nerve stimulation
The patients that are assigned to the sham TENS will receive an inactive placebo TENS therapy using a nonfunctional unit that appears to work but provides no stimulus.
- Overall average knee pain [ Time Frame: after 6 and 12 weeks ]numeric rating score
- Change from baseline in self reported knee pain and difficulty with physical function (WOMAC) [ Time Frame: baseline - 6 weeks ]
- Change from baseline in self reported knee pain and difficulty with physical function (WOMAC) [ Time Frame: baseline - 12 weeks ]