Knee OsteoarthritisNCT06418360
Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
A study testing TECAR and conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack in people with Knee Osteoarthritis and Energy Transfer Capacitative and Resistive Therapy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Energy Transfer Capacitative and Resistive Therapy
- What is being tested?
- TECAR and conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2023to 23 Nov 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 3 months of conservative treatment for unresponsive knee pain
- Kellgren-Lawrence grade 2-3 on radiographic evaluation
- Agreed to participate in the study.
Who cannot join
- History of physical therapy (electrotherapy/exercise) in the past 3 months
- Intra-articular injection therapy in the past 3 months,
- History of surgery or trauma to the affected knee
- Inflammatory or neurological disease affecting the lower extremities
- Active vasculitis or severe peripheral vascular disease
- Pregnancy or lactation
Show all 13Show fewer
- Diagnosed restless legs syndrome
- Neoplasia
- Local sensory impairment,
- Local or systemic acute infections
- Severe osteoporosis
- Pacemaker
- Psychiatric disorder and cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients.
Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months.
- Being tested
- TECAR, conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack
- Keywords
- knee pain, osteoarthritis, capacitative and resistive energy transfer therap
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECARDevice
Transfer Energy Capacitative and Resistive Therapy
conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpackDevice
10 sessions of HP and TENS for two weeks, five times a week. HP was applied to the painful knee area for 20 minutes using a heating pad for superficial heating purposes. TENS was applied to the painful knee area for 20 minutes at 80 Hz frequency
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy (CPT) | Experimental | Group 1 (HP, TENS, knee isometric and theraband exercise) to painful side knee area, two weeks, five times a week, 10 sessions. Receives: Device: conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack |
| conventional physical therapy (CPT) and TECAR therapy | Experimental | Group 2 (HP, TENS, knee isometric and theraband exercise) 10 sessions, two weeks, five times a week and in addition TECAR therapy, to painful side knee quadriceps and peripatellar area, three times a week for two weeks, for a total of 6 sessions. Receives: Device: TECAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
0 min , 10 is maximum pain score
Measured: Before and the after treatment 0th day , 1th month, 3rd month
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
This 24-item index comprises three subscales: pain, stiffness, and physical function, each measured on a five-point Likert scale ranging from "none" to "extreme."
Measured: Before and the after treatment 0th day, 1th month, 3rd month
Range of Motion (ROM)
Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points.
Measured: Before and the after treatment 0th day, 1th month, 3rd month
Secondary outcomes (1)
The Diers Myoline Isometric Muscle Strength Measurement System
quadriceps muscle Isometric Strength Measure: Increased isometric muscle strength is an indicator of recovery.
Measured: Before and the end of treatment 0th day, 1th month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start13 Mar 2023
- Primary completion23 Aug 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418360
- Sponsor's protocol ID
- E2-23-3792
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data will not share
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06418360
- Acronym / sponsor ID
- E2-23-3792
- Keywords
- knee pain, osteoarthritis, capacitative and resistive energy transfer therap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 17 May 2024 (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.
Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients.
Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy (CPT) | Experimental | Device: conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpackGroup 1 (HP, TENS, knee isometric and theraband exercise) to painful side knee area, two weeks, five times a week, 10 sessions. |
| conventional physical therapy (CPT) and TECAR therapy | Experimental | Device: TECARGroup 2 (HP, TENS, knee isometric and theraband exercise) 10 sessions, two weeks, five times a week and in addition TECAR therapy, to painful side knee quadriceps and peripatellar area, three times a week for two weeks, for a total of 6 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 3 months of conservative treatment for unresponsive knee pain
- Kellgren-Lawrence grade 2-3 on radiographic evaluation
- Agreed to participate in the study.
Key exclusion criteria (13 listed)
- History of physical therapy (electrotherapy/exercise) in the past 3 months
- Intra-articular injection therapy in the past 3 months,
- History of surgery or trauma to the affected knee
- Inflammatory or neurological disease affecting the lower extremities
- Active vasculitis or severe peripheral vascular disease
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 |
|---|---|---|
| TECARTransfer Energy Capacitative and Resistive Therapy | Device | conventional physical therapy (CPT) and TECAR therapy |
| conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack10 sessions of HP and TENS for two weeks, five times a week. HP was applied to the painful knee area for 20 minutes using a heating pad for superficial heating purposes. TENS was applied to the painful knee area for 20 minutes at 80 Hz frequency | Device | conventional physical therapy (CPT) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before and the after treatment 0th day , 1th month, 3rd month
0 min , 10 is maximum pain score
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Before and the after treatment 0th day, 1th month, 3rd month
This 24-item index comprises three subscales: pain, stiffness, and physical function, each measured on a five-point Likert scale ranging from "none" to "extreme."
Range of Motion (ROM)
Time frame: Before and the after treatment 0th day, 1th month, 3rd month
Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points.
1 secondary outcome
The Diers Myoline Isometric Muscle Strength Measurement System
Time frame: Before and the end of treatment 0th day, 1th month, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No. participant data will not share
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR and conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack in people with Knee Osteoarthritis and Energy Transfer Capacitative and Resistive Therapy, run by Ankara City Hospital Bilkent 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 13 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: finished, as of the sponsor's last update on 17 May 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Before and the after treatment 0th day , 1th month, 3rd month). The study lists 3 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 17 May 2024.