Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Turkish League Against Rheumatism

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: Sham transcutaneous Electrical Nerve Stimulation; Other: Hydrocollator hot-pack; Device: Sham interferential Current; Device: Interferential Current; Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04153825

TRASD1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Active TENS Group

Active Comparator group

Description:

Ten sessions of active conventional TENS and hydrocollator hot-pack.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Other: Hydrocollator hot-pack

Active IFC Group

Active Comparator group

Description:

Ten sessions of active interferential current and hydrocollator hot-pack.

Treatment:

Device: Interferential Current

Other: Hydrocollator hot-pack

Sham TENS Group

Sham Comparator group

Description:

Ten sessions of sham TENS and hydrocollator hot-pack.

Treatment:

Device: Sham transcutaneous Electrical Nerve Stimulation

Other: Hydrocollator hot-pack

Sham IFC Group

Sham Comparator group

Description:

Ten sessions of sham IFC and hydrocollator hot-pack.

Treatment:

Device: Sham interferential Current

Other: Hydrocollator hot-pack