Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

NCT04153825 | Unknown FDA Device

• 1 other identifier: TRASD1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

Physical therapy modalities; Osteoarthritis knee; Central nervous system sensitization; Pain; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (4)

• Pressure-pain thresholds

  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.

  Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks

• Tampa Scale of Kinesiophobia

  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.

  Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks

• Beck Depression Inventory (BDI)

  Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.

  Change from baseline BDI scores at 2 weeks and at 12 weeks.

• Pain catastrophizing scale (PCS)

  PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain.

  Change from baseline PCS scores at 2 weeks and at 12 weeks.

Secondary Outcomes (9)

• Age

  Baseline

• Gender

  Baseline

• Height

  Baseline

• Weight

  Baseline

• Comorbidity

  Baseline

Study Arms (4)

Active TENS Group

ACTIVE COMPARATOR

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

Device: Transcutaneous Electrical Nerve Stimulation; Other: Hydrocollator hot-pack

Active IFC Group

ACTIVE COMPARATOR

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

Device: Interferential Current; Other: Hydrocollator hot-pack

Sham TENS Group

SHAM COMPARATOR

Ten sessions of sham TENS and hydrocollator hot-pack.

Other: Hydrocollator hot-pack; Device: Sham transcutaneous Electrical Nerve Stimulation

Sham IFC Group

SHAM COMPARATOR

Ten sessions of sham IFC and hydrocollator hot-pack.

Other: Hydrocollator hot-pack; Device: Sham interferential Current

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended. The device is set at pulse duration of 50 to 80 μs; pulse frequency of 50 to 100 Hz; low-intensity (paraesthesia, not painful). The patient wears TENS for a 20-minute duration for each knee.

Also known as: TENS

Active TENS Group

Interferential Current DEVICE

Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. The device is set at carrier frequency 4000 Hz, amplitude modulated frequency (AMF) 100 Hz, scanning frequency 50 Hz, scanning mode 1: 1 s. The patient wears ICF for a 20-minute duration for each knee.

Also known as: IFC

Active IFC Group

Hydrocollator hot-pack OTHER

The hot-pack (at a surface temperature of almost 42 °C) is administered on knees while patients are in sitting position with the knees extended. Every session includes 20 minutes of hot-pack for each knee.

Active IFC Group; Active TENS Group; Sham IFC Group; Sham TENS Group

Sham transcutaneous Electrical Nerve Stimulation DEVICE

Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended.TENS unit in place but not turned on.The patient wears TENS for a 20-minute duration for each knee.

Also known as: Sham TENS

Sham TENS Group

Sham interferential Current DEVICE

Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. IFC unit in place but not turned on.The patient wears ICF for a 20-minute duration for each knee.

Also known as: Sham IFC

Sham IFC Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Turkish League Against Rheumatism: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Şahide E Almaz, MD

  Turkish League Against Rheumatism

  PRINCIPAL INVESTIGATOR

• Hatice Bodur, Professor

  Turkish League Against Rheumatism

  STUDY DIRECTOR

• Aslı Çalışkan Uçkun, MD

  Turkish League Against Rheumatism

  STUDY CHAIR

• Filiz Acar Sivas, Professor

  Turkish League Against Rheumatism

  STUDY CHAIR

• Fatma G Yurdakul, MD

  Turkish League Against Rheumatism

  STUDY CHAIR

Central Study Contacts

Şahide E Almaz, MD

CONTACT

+905534488730; edartuc@gmail.com

Hatice Bodur, Professor

CONTACT

+905054848496; haticebodur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 6, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)