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
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
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
NCT ID
NCT01390285
First Posted
April 13, 2011
Last Updated
July 6, 2011
Sponsor
Vrije Universiteit Brussel
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
Learn more about this trial
Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee
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