Back to resultsComparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Interferential Current
Hydrocollator hot-pack
Sham transcutaneous Electrical Nerve Stimulation
Sham interferential Current
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy
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:
- 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 -
Sites / Locations
- Ankara City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Sham Comparator
Arm Label
Active TENS Group
Active IFC Group
Sham TENS Group
Sham IFC Group
Arm Description
Ten sessions of active conventional TENS and hydrocollator hot-pack.
Ten sessions of active interferential current and hydrocollator hot-pack.
Ten sessions of sham TENS and hydrocollator hot-pack.
Ten sessions of sham IFC and hydrocollator hot-pack.
Outcomes
Primary Outcome Measures
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.
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.
Beck Depression Inventory (BDI)
Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.
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.
Secondary Outcome Measures
Age
years
Gender
female/male
Height
centimeter (cm)
Weight
kilogram (kg)
Comorbidity
self reported
Visual analogue scale (VAS)
VAS ranging levels from 0 (no pain) to 10 (maximal pain).
Western Ontario and McMaster University (WOMAC) Index.
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)
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
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.
Full Information
NCT ID
NCT04153825
First Posted
October 30, 2019
Last Updated
November 4, 2019
Sponsor
Turkish League Against Rheumatism
1. Study Identification
Unique Protocol Identification Number
NCT04153825
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turkish League Against Rheumatism
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active TENS Group
Arm Type
Active Comparator
Arm Description
Ten sessions of active conventional TENS and hydrocollator hot-pack.
Arm Title
Active IFC Group
Arm Type
Active Comparator
Arm Description
Ten sessions of active interferential current and hydrocollator hot-pack.
Arm Title
Sham TENS Group
Arm Type
Sham Comparator
Arm Description
Ten sessions of sham TENS and hydrocollator hot-pack.
Arm Title
Sham IFC Group
Arm Type
Sham Comparator
Arm Description
Ten sessions of sham IFC and hydrocollator hot-pack.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Interferential Current
Other Intervention Name(s)
IFC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hydrocollator hot-pack
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
Sham TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham interferential Current
Other Intervention Name(s)
Sham IFC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure-pain thresholds
Description
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.
Time Frame
Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks
Title
Tampa Scale of Kinesiophobia
Description
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.
Time Frame
Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks
Title
Beck Depression Inventory (BDI)
Description
Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.
Time Frame
Change from baseline BDI scores at 2 weeks and at 12 weeks.
Title
Pain catastrophizing scale (PCS)
Description
PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain.
Time Frame
Change from baseline PCS scores at 2 weeks and at 12 weeks.
Secondary Outcome Measure Information:
Title
Age
Description
years
Time Frame
Baseline
Title
Gender
Description
female/male
Time Frame
Baseline
Title
Height
Description
centimeter (cm)
Time Frame
Baseline
Title
Weight
Description
kilogram (kg)
Time Frame
Baseline
Title
Comorbidity
Description
self reported
Time Frame
Baseline
Title
Visual analogue scale (VAS)
Description
VAS ranging levels from 0 (no pain) to 10 (maximal pain).
Time Frame
Change from baseline, at 2 weeks and at 12 weeks
Title
Western Ontario and McMaster University (WOMAC) Index.
Description
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.
Time Frame
Change from baseline, at 2 weeks and at 12 weeks
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
Change from baseline, at 2 weeks and at 12 weeks
Title
Five Times Sit to Stand Test
Description
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.
Time Frame
Change from baseline, at 2 weeks and at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Şahide E Almaz, MD
Phone
+905534488730
Email
edartuc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice Bodur, Professor
Phone
+905054848496
Email
haticebodur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şahide E Almaz, MD
Organizational Affiliation
Turkish League Against Rheumatism
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hatice Bodur, Professor
Organizational Affiliation
Turkish League Against Rheumatism
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aslı Çalışkan Uçkun, MD
Organizational Affiliation
Turkish League Against Rheumatism
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Filiz Acar Sivas, Professor
Organizational Affiliation
Turkish League Against Rheumatism
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatma G Yurdakul, MD
Organizational Affiliation
Turkish League Against Rheumatism
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Şahide E Almaz, MD
Phone
+905534488730
Email
edartuc@gmail.com
First Name & Middle Initial & Last Name & Degree
Hatice Bodur
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All the collected data will be shared with investigators of the study.
Learn more about this trial
Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization
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