Osteoarthritis, KneeNCT04153825
Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization
A study testing Transcutaneous Electrical Nerve Stimulation, Interferential Current and Hydrocollator hot-pack in people with Osteoarthritis, Knee, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation, Interferential Current and Hydrocollator hot-pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara
Şahide E Almaz, MD, +905534488730, edartuc@gmail.com
Hatice Bodur
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on Central Sensitization in Patients With Knee Osteoarthritis: Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Interferential Current, Hydrocollator hot-pack, Sham transcutaneous Electrical Nerve Stimulation, Sham interferential Current
- Keywords
- Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
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.
Interferential CurrentDevice
Also called IFC
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.
Hydrocollator hot-packOther
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.
Sham transcutaneous Electrical Nerve StimulationDevice
Also called Sham TENS
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.
Sham interferential CurrentDevice
Also called Sham IFC
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.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS Group | Active comparator | Ten sessions of active conventional TENS and hydrocollator hot-pack. Receives: Device: Transcutaneous Electrical Nerve Stimulation; Other: Hydrocollator hot-pack |
| Active IFC Group | Active comparator | Ten sessions of active interferential current and hydrocollator hot-pack. Receives: Device: Interferential Current; Other: Hydrocollator hot-pack |
| Sham TENS Group | Sham comparator | Ten sessions of sham TENS and hydrocollator hot-pack. Receives: Other: Hydrocollator hot-pack; Device: Sham transcutaneous Electrical Nerve Stimulation |
| Sham IFC Group | Sham comparator | Ten sessions of sham IFC and hydrocollator hot-pack. Receives: Other: Hydrocollator hot-pack; Device: Sham interferential Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline PCS scores at 2 weeks and at 12 weeks.
Secondary outcomes (9)
Age
years
Measured: Baseline
Gender
female/male
Measured: Baseline
Height
centimeter (cm)
Measured: Baseline
Weight
kilogram (kg)
Measured: Baseline
Comorbidity
self reported
Measured: Baseline
Visual analogue scale (VAS)
VAS ranging levels from 0 (no pain) to 10 (maximal pain).
Measured: Change from baseline, at 2 weeks and at 12 weeks
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.
Measured: Change from baseline, at 2 weeks and at 12 weeks
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.
Measured: Change from baseline, at 2 weeks and at 12 weeks
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.
Measured: Change from baseline, at 2 weeks and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahide Eda Almaz, Turkish League Against Rheumatism
- Investigators
- Şahide E Almaz, MD, Principal investigator, Turkish League Against RheumatismHatice Bodur, Professor, Study director, Turkish League Against RheumatismAslı Çalışkan Uçkun, MD, Study chair, Turkish League Against RheumatismFiliz Acar Sivas, Professor, Study chair, Turkish League Against RheumatismFatma G Yurdakul, MD, Study chair, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153825
- Sponsor's protocol ID
- TRASD1
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All the collected data will be shared with investigators of the study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on Central Sensitization in Patients With Knee Osteoarthritis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04153825
- Acronym / sponsor ID
- TRASD1
- Conditions
- Osteoarthritis, Knee
- Keywords
- Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active TENS Group | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation, Other: Hydrocollator hot-packTen sessions of active conventional TENS and hydrocollator hot-pack. |
| Active IFC Group | Active comparator | Device: Interferential Current, Other: Hydrocollator hot-packTen sessions of active interferential current and hydrocollator hot-pack. |
| Sham TENS Group | Sham comparator | Other: Hydrocollator hot-pack, Device: Sham transcutaneous Electrical Nerve StimulationTen sessions of sham TENS and hydrocollator hot-pack. |
| Sham IFC Group | Sham comparator | Other: Hydrocollator hot-pack, Device: Sham interferential CurrentTen sessions of sham IFC and hydrocollator hot-pack. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENSElectrodes 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. | Device | Active TENS Group |
| Interferential CurrentAlso: IFCElectrodes 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. | Device | Active IFC Group |
| Hydrocollator hot-packThe 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. | Other | Active IFC Group, Active TENS Group, Sham IFC Group, Sham TENS Group |
| Sham transcutaneous Electrical Nerve StimulationAlso: Sham TENSElectrodes 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. | Device | Sham TENS Group |
| Sham interferential CurrentAlso: Sham IFCElectrodes 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. | Device | Sham IFC Group |
Primary outcome
Pressure-pain thresholds
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Age
Time frame: Baseline
Gender
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Comorbidity
Time frame: Baseline
Visual analogue scale (VAS)
Time frame: Change from baseline, at 2 weeks and at 12 weeks
Western Ontario and McMaster University (WOMAC) Index.
Time frame: Change from baseline, at 2 weeks and at 12 weeks
Timed Up and Go Test (TUG)
Time frame: Change from baseline, at 2 weeks and at 12 weeks
Five Times Sit to Stand Test
Time frame: Change from baseline, at 2 weeks and at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Yes. All the collected data will be shared with investigators of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şahide E Almaz, MD principal investigator
Turkish League Against Rheumatism
Hatice Bodur, Professor study director
Turkish League Against Rheumatism
Aslı Çalışkan Uçkun, MD study chair
Turkish League Against Rheumatism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation, Interferential Current and Hydrocollator hot-pack in people with Osteoarthritis, Knee, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şahide E Almaz, MD (+905534488730, edartuc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-pain thresholds (time frame: Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.