Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Transcutaneous Electrical Nerve Stimulation; Device: Interferential Current; Other: Hydrocollator hot-pack; Device: Sham transcutaneous Electrical Nerve Stimulation; Device: Sham interferential Current

• Registration Number: NCT04153825
• Lead Sponsor: Turkish League Against Rheumatism

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-10-30
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active IFC Group	Hydrocollator hot-pack	Ten sessions of active interferential current and hydrocollator hot-pack.
Sham TENS Group	Hydrocollator hot-pack	Ten sessions of sham TENS and hydrocollator hot-pack.
Sham IFC Group	Hydrocollator hot-pack	Ten sessions of sham IFC and hydrocollator hot-pack.
Active TENS Group	Transcutaneous Electrical Nerve Stimulation	Ten sessions of active conventional TENS and hydrocollator hot-pack.
Active IFC Group	Interferential Current	Ten sessions of active interferential current and hydrocollator hot-pack.
Active TENS Group	Hydrocollator hot-pack	Ten sessions of active conventional TENS and hydrocollator hot-pack.
Sham TENS Group	Sham transcutaneous Electrical Nerve Stimulation	Ten sessions of sham TENS and hydrocollator hot-pack.
Sham IFC Group	Sham interferential Current	Ten sessions of sham IFC and hydrocollator hot-pack.

Primary Outcome Measures

Name	Time	Method
Pressure-pain thresholds	Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks	Pressure pain thresholds is measured on the knee (M. Vastus Medialis) and on the upper part of the homolateral arm (lateral part of M. Deltoideus, 10 cm below acromion) using a pressure algometer. The pressure is raised at a rate of almost 1 kg/s, until the patient first notifies that the pressure sensation changes to a pain sensation.
Tampa Scale of Kinesiophobia	Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks	Tampa Scale contains 17 parts that measure anxiety and fear related to movement. The total score ranges between 17-68 points. Higher scores represent higher grades of kinesiophobia.
Beck Depression Inventory (BDI)	Change from baseline BDI scores at 2 weeks and at 12 weeks.	Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.
Pain catastrophizing scale (PCS)	Change from baseline PCS scores at 2 weeks and at 12 weeks.	PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain.

Secondary Outcome Measures

Name	Time	Method
Age	Baseline	years
Gender	Baseline	female/male
Height	Baseline	centimeter (cm)
Weight	Baseline	kilogram (kg)
Comorbidity	Baseline	self reported
Visual analogue scale (VAS)	Change from baseline, at 2 weeks and at 12 weeks	VAS ranging levels from 0 (no pain) to 10 (maximal pain).
Western Ontario and McMaster University (WOMAC) Index.	Change from baseline, at 2 weeks and at 12 weeks	There are three subscales with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.; Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Timed Up and Go Test (TUG)	Change from baseline, at 2 weeks and at 12 weeks	Timed up and go test is used to assess mobility which recorded the time of rising from a back-rest chair, walking at a normal pace 3 meters, turning, walking back to the chair, and sitting recumbently. In one minute durations, each participant will perform the test three times and this time will be recorded in seconds.
Five Times Sit to Stand Test	Change from baseline, at 2 weeks and at 12 weeks	The participant is asked to sit-to-stand action from a standard chair five times as quickly as possible, and the time taken to complete is recorded.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey