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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
Sponsor:
Information provided by:
Vrije Universiteit Brussel

Brief Summary:

Background

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.

Purpose

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.

Methods

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.

Discussion/ conclusion

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: TENS 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.




Primary Outcome Measures :
  1. Overall average knee pain [ Time Frame: after 6 and 12 weeks ]
    numeric rating score


Secondary Outcome Measures :
  1. Change from baseline in self reported knee pain and difficulty with physical function (WOMAC) [ Time Frame: baseline - 6 weeks ]
  2. Change from baseline in self reported knee pain and difficulty with physical function (WOMAC) [ Time Frame: baseline - 12 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be included, patients need to be over 50 years old.
  • All should have osteoarthritis in at least one knee fulfilling the American College of Rheumatology classification criteria and report peak knee pain over the last 24 h of more than 3 on a Numeric Rating Score (0-10 scale).

Exclusion Criteria:

  • Patients are excluded if they have had a knee surgery or intra-articular corticosteroid injection within 6 months
  • Current or past (within 4 weeks) oral corticosteroid use
  • A history of knee joint replacement or tibial osteotomy
  • Contraindications to burst TENS (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy) or if they are unable to apply TENS independently

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Beckwée, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01390285     History of Changes
Other Study ID Numbers: Tenssens
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases