Clinical trial NCT04153825: Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization
Official title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on Central Sensitization in Patients With Knee Osteoarthritis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Physical therapy modalities
Osteoarthritis knee
Central nervous system sensitization
Pain
Electric Stimulation Therapy
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential currents (IFCs) and sham devices in improving central sensitization (CS) findings, including pressure pain thresholds, pain catastrophizing, depression, and kinesiophobia in patients with knee osteoarthritis (OA).

Detailed description: Knee OA, which is the most frequently encountered type of OA is a leading cause of disability and chronic pain. CS is as important as nociceptive component in the pathogenesis of OA-related pain. Therefore, the necessary interventions for CS should be also considered when deciding the treatment protocol.TENS and IFC have been safely and commonly employed in the conservative treatment of knee OA. However, there are limited and inconsistent data concerning the impact of these modalities on CS component of pain.Therefore, the aim of this study is to investigate whether these agents are effective on CS and they are superior to each other.

Eligibility criteria: Inclusion Criteria:

40 to 75 years of age, Having bilateral knee OA radiologically with a Kellgren-Lawrence grade of 2 or 3.

Reporting knee pain of more than 3 on the visual analog scale (VAS) over the last 6 months Being unfamiliar with TENS and IFC use

-

Exclusion Criteria:

1. Having the history of any contraindication for electrotherapy (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy),
2. Having a knee surgery or intra-articular corticosteroid or hyaluronic acid injection within 6 months.
3. Taking any drugs acting on the nervous system such as anticonvulsants, antidepressants, myorelaxants, or opioid drugs in the study period.
4. Having fibromyalgia, inflammatory rheumatologic, severe psychological disorders -

Primary outcomes:
measure: Pressure-pain thresholds
timeFrame: Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks
measure: Tampa Scale of Kinesiophobia
timeFrame: Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline BDI scores at 2 weeks and at 12 weeks.
measure: Pain catastrophizing scale (PCS)
timeFrame: Change from baseline PCS scores at 2 weeks and at 12 weeks.
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Comorbidity
timeFrame: Baseline
measure: Visual analogue scale (VAS)
timeFrame: Change from baseline, at 2 weeks and at 12 weeks
measure: Western Ontario and McMaster University (WOMAC) Index.
timeFrame: Change from baseline, at 2 weeks and at 12 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from baseline, at 2 weeks and at 12 weeks
measure: Five Times Sit to Stand Test
timeFrame: Change from baseline, at 2 weeks and at 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Turkish League Against Rheumatism
name: Şahide E Almaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Hatice Bodur, Professor
role: STUDY_DIRECTOR
affiliation: Turkish League Against Rheumatism
name: Aslı Çalışkan Uçkun, MD
role: STUDY_CHAIR
affiliation: Turkish League Against Rheumatism
name: Filiz Acar Sivas, Professor
role: STUDY_CHAIR
affiliation: Turkish League Against Rheumatism
name: Fatma G Yurdakul, MD
role: STUDY_CHAIR
References: