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Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee (TENSSENS)

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electric nerve stimulation
sham transcutaneous electrical nerve stimulation
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    TENS

    Sham TENS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall average knee pain
    numeric rating score

    Secondary Outcome Measures

    Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)
    Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)

    Full Information

    First Posted
    April 13, 2011
    Last Updated
    July 6, 2011
    Sponsor
    Vrije Universiteit Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01390285
    Brief Title
    Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee
    Acronym
    TENSSENS
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    March 2014 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Vrije Universiteit Brussel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TENS
    Arm Type
    Experimental
    Arm Title
    Sham TENS
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous electric nerve stimulation
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    sham transcutaneous electrical nerve stimulation
    Intervention Description
    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 Measure Information:
    Title
    Overall average knee pain
    Description
    numeric rating score
    Time Frame
    after 6 and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)
    Time Frame
    baseline - 6 weeks
    Title
    Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)
    Time Frame
    baseline - 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22353582
    Citation
    Beckwee 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.
    Results Reference
    derived

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    Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee

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