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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

Tracking Information
First Submitted Date  ICMJE April 13, 2011
First Posted Date  ICMJE July 11, 2011
Last Update Posted Date July 11, 2011
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
Overall average knee pain [ Time Frame: after 6 and 12 weeks ]
numeric rating score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee
Official Title  ICMJE Effect of Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Patients With Osteoarthritis of the Knee: a Randomized Controlled Clinical Trial.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: TENS
    Intervention: Device: Transcutaneous electric nerve stimulation
  • Sham Comparator: Sham TENS
    Intervention: Device: sham transcutaneous electrical nerve stimulation
Publications * Beckwée D, De Hertogh W, Lievens P, Bautmans I, Vaes P. Effect of tens on pain in relation to central sensitization in patients with osteoarthritis of the knee: study protocol of a randomized controlled trial. Trials. 2012 Feb 21;13:21. doi: 10.1186/1745-6215-13-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 6, 2011)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01390285
Other Study ID Numbers  ICMJE Tenssens
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Beckwée, Vrije Universiteit Brussel
Study Sponsor  ICMJE Vrije Universiteit Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vrije Universiteit Brussel
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP