- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438392
Tecar Therapy in Chronic Knee Osteoarthritis
Effects of Tecar Therapy (Targeted Radiofrequency Therapy) on Pain, Physical Function, and Physical Capacity in Patients With Chronic Knee Osteoarthritis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis is a degenerative, inflammatory, and chronic joint disease with an increasing incidence and prevalence worldwide. By causing pain, disability, and deterioration in quality of life, it constitutes a significant public health problem globally. Furthermore, the health, social, and economic burdens associated with chronic knee osteoarthritis are expected to increase in the future. For these reasons, and due to the rising incidence of the disease, clinicians are increasingly focusing on novel treatment strategies.
Currently, both surgical and non-surgical treatment modalities are used in the management of chronic knee osteoarthritis. The cornerstone of treatment consists of patient education, exercise, and weight control. Subsequent steps include pharmacological treatments, intra-articular injections, and physical therapy modalities. These modalities include transcutaneous electrical stimulation, therapeutic ultrasound, thermal modalities, laser therapy, extracorporeal shock wave therapy, electromagnetic field therapy, and capacitive and resistive electric transfer (Tecar therapy).
Tecar therapy is an endogenous diathermy modality that operates in the long-wave range using radiofrequency energy of approximately 0.5 MHz to heat the treated tissues. It consists of two electrodes-capacitive and resistive-with a long-wave current generator and multi-frequency sequential emission systems that deliver energy to tissues in two different modes. In the capacitive mode, an insulated electrode with a metal plate is generally used. The electrical charges generated by the radiofrequency generator accumulate near the insulated electrode, which acts as a dielectric surface. This method is used for the treatment of superficial tissues adjacent to the insulated electrode. In the resistive mode, two metal electrodes distribute electrical charges that tend to accumulate near bone, tendon, and connective tissue.
Tecar therapy has been shown to have positive effects on pain and quality of life in many patients with degenerative and inflammatory orthopedic conditions. Among diathermy modalities, Tecar therapy is considered one of the most appropriate and safe methods, as-unlike ultrasound-it has no limitation in terms of treatment area and does not cause excessive heat accumulation between the skin and the electrode .
To the best of our knowledge, there are very few studies investigating the use of Tecar therapy in chronic knee osteoarthritis. Therefore, the aim of this study was to investigate the effects of Tecar therapy on pain, physical function, and physical capacity in patients with chronic knee osteoarthritis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nazife K Kapan Tunçer, Asst. Prof.
- Phone Number: +90 5555839701
- Email: nazifekapan@gmail.com
Study Locations
-
-
Kırşehir
-
Kırşehir, Kırşehir, Turkey (Türkiye)
- Kırşehir Ahi Evran Üniversitesi
-
Contact:
- Nazife Kapan Tunçer, Asst. Prof.
- Phone Number: 03862803924
- Email: nazifekapan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with Kellgren-Lawrence stage 2 or 3 knee osteoarthritis
- Patients with bilateral knee pain for at least 6 weeks
- Male and female patients aged 40-75
- Patients who accept and sign the informed consent form
Exclusion Criteria:
- Those who have received physical therapy for knee pain in the last 6 months
- Those who have received intraarticular injection treatments such as hyaluronic acid, PRP, or steroids for knee pain in the last 6 months
- Those who have undergone knee surgery for any reason
- Those with inflammatory arthritis
- Those with existing neurological, cognitive, or psychiatric disorders
- Those with pacemakers
- Those with a history of malignancy
- Those with local vascular or sensory impairment
- Those with local or systemic infections
- Those with open wounds on the skin
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tecar theraphy
Conventional physical therapy and Tecar therapy: Conventional physiotherapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist. This group will also receive TECAR therapy three times a week for three weeks, a total of nine sessions, at 0.5 MHz frequency, in a 5 min CAP + 10 min RES + 5 min CAP mode, administered by an experienced physiotherapist. |
conventional physical therapy
Tecar Therapy and conventional physical therapy
|
|
Experimental: Sham tecar theraphy
Conventional physical therapy and sham Tecar therapy: Conventional physiotherapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist. This group will also receive TECAR sham therapy three times a week for three weeks, a total of nine sessions, at 0.5 MHz frequency, in a 5 min CAP + 10 min RES + 5 min CAP mode, administered by an experienced physiotherapist. The gel will be applied before the device is activated. |
conventional physical therapy
ShamTecar Therapy and conventional physical therapy
|
|
Experimental: conventional physiotherapy
Conventional FTR: Conventional physical therapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist. |
conventional physical therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: baseline, 3th week, 12th week
|
VAS is a pain rating scale with numbers 0 and 10.
Here 0 means 'no pain' and 10 means 'unbearable pain'.
The participant will rate the pain according to the scale.
Patients' night, rest and activity pain will be evaluated separately.
|
baseline, 3th week, 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC
Time Frame: baseline, 3th week, 12th week
|
WOMAC consists of three main subgroups: pain, stiffness, and difficulty performing daily activities.
It is a questionnaire with a total of 24 questions.
Each question has five alternative answers: none, mild, moderate, severe, and very severe.
Scoring is given as follows: pain (maximum 20), stiffness (8), and difficulty performing daily activities (68).
High scores indicate worsening symptoms, significant limitations, and insufficient overall health.
The Turkish version of the scale was developed by Tüzün et al. in 2005.
|
baseline, 3th week, 12th week
|
|
The 6-minute walk test (6MWT)
Time Frame: baseline, 3th week, 12th week
|
The 6-minute walk test (6MWT) will be used to assess physical capacity.
Patients will be asked to walk at their preferred pace for 6 minutes in a 30-meter corridor marked at 3-meter intervals.
Rest periods or adjustments to walking speed will be allowed if necessary.
The maximum distance covered in 6 minutes along the 30-meter corridor will be measured.
|
baseline, 3th week, 12th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Coccetta CA, Sale P, Ferrara PE, Specchia A, Maccauro G, Ferriero G, Ronconi G. Effects of capacitive and resistive electric transfer therapy in patients with knee osteoarthritis: a randomized controlled trial. Int J Rehabil Res. 2019 Jun;42(2):106-111. doi: 10.1097/MRR.0000000000000324.
- Elboim-Gabyzon M, Nahhas F. Laser therapy versus pulsed electromagnetic field therapy as treatment modalities for early knee osteoarthritis: a randomized controlled trial. BMC Geriatr. 2023 Mar 16;23(1):144. doi: 10.1186/s12877-022-03568-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AhiEvranU-FTR-NK-Tecar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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