Knee OsteoarthritisNCT07633795
Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis
A study testing True TECAR Therapy and Traditional Physiotherapy in people with Knee Osteoarthritis, run by Middle East University at 1 site in Egypt.
Trial summary
Evaluate the effect of TECAR therapy combined with traditional physiotherapy on pain, balance, and quality of life in elderly men with knee osteoarthritis . Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- True TECAR Therapy and Traditional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 16 Oct 2026
- 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 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical and radiographic diagnosis of mild and moderate bilateral or unilateral knee osteoarthritis meeting the American College of Rheumatology (ACR) criteria.
- Presence of chronic knee pain lasting for more than 6 months.
- Ability to ambulate independently with or without an assistive device.
Who cannot join
- Severe knee osteoarthritis (grade IV) requiring imminent surgical joint replacement.
- History of previous knee arthroplasty, internal fixation, or significant trauma to the affected lower extremity.
- Presence of pacemakers, metallic implants in the knee region, or severe. - peripheral vascular disease (absolute contraindications for TECAR therapy).
- Intra-articular injections (corticosteroids, platelet-rich plasma, or hyaluronic acid) into the knee within the past 3 months.
- Cognitive impairment or systemic inflammatory conditions (e.g., rheumatoid arthritis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis: A Randomized Controlled Trial
Evaluate the effect of TECAR therapy combined with traditional physiotherapy on pain, balance, and quality of life in elderly men with knee osteoarthritis .
Read the detailed description
Eighty elderly men diagnosed with knee osteoarthritis will be recruited from physical therapy and orthopedic outpatient clinics. Following a baseline screening, patients will be randomly assigned into two parallel groups:
The Study Group: Will include 40 men participating in true TECAR therapy plus a standardized traditional physiotherapy program for 8 weeks.
The Control Group: Will include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- True TECAR Therapy, Sham TECAR, Traditional Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True TECAR TherapyDevice
20 minutes per session (10 mins capacitive mode, 10 mins resistive mode), 3 sessions per week for 8 weeks will be applied around the affected knee joint. Thermal delivery will be adjusted to a comfortable, non-painful warm sensation
Sham TECARDevice
The device will be applied using identical electrode placement, application time, and interface screen indicators, but with the power output disabled so that no current or deep thermal energy is transferred to the tissues.
Traditional PhysiotherapyOther
Standardized knee osteoarthritis rehabilitation including progressive quad/hamstring strengthening, hip abductor strengthening, range of motion exercises, and flexibility training
| Study group | Role | What they receive |
|---|---|---|
| TECAR group | Active comparator | 40 elderly men with knee osteoarthritis who will receive TECAR therapy combined with a traditional physiotherapy program for 8 weeks Receives: Device: True TECAR Therapy; Other: Traditional Physiotherapy |
| Sham TECAR group | Sham comparator | Will include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks Receives: Device: Sham TECAR; Other: Traditional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg Balance Scale will be used to assess balance. The Berg Balance Scale is a 14-item objective clinical assessment designed to measure static and dynamic balance capabilities, with total scores ranging from a minimum of 0 to a maximum of 56, where higher scores indicate a better outcome (greater functional stability, increased independence, and lower fall risk).
Measured: Baseline and after 8 weeks
Secondary outcomes (4)
Pain Intensity
Visual Analog Scale will be used to assess pain intensity. Visual Analog Scale score ranges from 0 to 10, with higher scores indicate more severe pain.
Measured: Baseline and after 8 weeks
Health-Related Quality of Life
Short Form-12 Health Survey will be used to assess quality of life. The Short Form-12 Health Survey is a twelve-item self-reported questionnaire designed to assess generic health-related quality of life across Physical Component Summary and Mental Component Summary domains, with standardized scores ranging from a minimum of zero to a maximum of one hundred, where higher scores indicate a better outcome (better physical health, mental health, and overall functional performance).
Measured: Baseline and after 8 weeks
Quadriceps Isokinetic Strength
An isokinetic dynamometer assesses concentric quadriceps muscle strength and power bilaterally. Participants perform maximal voluntary knee extensions and flexions at specific angular velocities of 60 and 180 degrees.
Measured: Baseline and after 8 weeks
Isokinetic Knee Flexion / Extension Range of Motion
Will be assessed using an isokinetic dynamometer which simultaneously tracks joint range of motion (in degrees) via built-in optical encoders.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026
- Primary completion12 Oct 2026
- Study completion16 Oct 2026
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.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633795
- Sponsor's protocol ID
- TECAR therapy on Arthritis
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07633795
- Acronym / sponsor ID
- TECAR therapy on Arthritis
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 16 Oct 2026 (actual)
- First posted
- 8 Jun 2026 (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.
Evaluate the effect of TECAR therapy combined with traditional physiotherapy on pain, balance, and quality of life in elderly men with knee osteoarthritis .
Detailed description
Eighty elderly men diagnosed with knee osteoarthritis will be recruited from physical therapy and orthopedic outpatient clinics. Following a baseline screening, patients will be randomly assigned into two parallel groups:
The Study Group: Will include 40 men participating in true TECAR therapy plus a standardized traditional physiotherapy program for 8 weeks.
The Control Group: Will include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECAR group | Active comparator | Device: True TECAR Therapy, Other: Traditional Physiotherapy40 elderly men with knee osteoarthritis who will receive TECAR therapy combined with a traditional physiotherapy program for 8 weeks |
| Sham TECAR group | Sham comparator | Device: Sham TECAR, Other: Traditional PhysiotherapyWill include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Clinical and radiographic diagnosis of mild and moderate bilateral or unilateral knee osteoarthritis meeting the American College of Rheumatology (ACR) criteria.
- Presence of chronic knee pain lasting for more than 6 months.
- Ability to ambulate independently with or without an assistive device.
Key exclusion criteria (5 listed)
- Severe knee osteoarthritis (grade IV) requiring imminent surgical joint replacement.
- History of previous knee arthroplasty, internal fixation, or significant trauma to the affected lower extremity.
- Presence of pacemakers, metallic implants in the knee region, or severe. - peripheral vascular disease (absolute contraindications for TECAR therapy).
- Intra-articular injections (corticosteroids, platelet-rich plasma, or hyaluronic acid) into the knee within the past 3 months.
- Cognitive impairment or systemic inflammatory conditions (e.g., rheumatoid arthritis).
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 |
|---|---|---|
| True TECAR Therapy20 minutes per session (10 mins capacitive mode, 10 mins resistive mode), 3 sessions per week for 8 weeks will be applied around the affected knee joint. Thermal delivery will be adjusted to a comfortable, non-painful warm sensation | Device | TECAR group |
| Sham TECARThe device will be applied using identical electrode placement, application time, and interface screen indicators, but with the power output disabled so that no current or deep thermal energy is transferred to the tissues. | Device | Sham TECAR group |
| Traditional PhysiotherapyStandardized knee osteoarthritis rehabilitation including progressive quad/hamstring strengthening, hip abductor strengthening, range of motion exercises, and flexibility training | Other | Sham TECAR group, TECAR group |
Primary outcome
Balance
Time frame: Baseline and after 8 weeks
Berg Balance Scale will be used to assess balance. The Berg Balance Scale is a 14-item objective clinical assessment designed to measure static and dynamic balance capabilities, with total scores ranging from a minimum of 0 to a maximum of 56, where higher scores indicate a better outcome (greater functional stability, increased independence, and lower fall risk).
4 secondary outcomes
Pain Intensity
Time frame: Baseline and after 8 weeks
Health-Related Quality of Life
Time frame: Baseline and after 8 weeks
Quadriceps Isokinetic Strength
Time frame: Baseline and after 8 weeks
Isokinetic Knee Flexion / Extension Range of Motion
Time frame: Baseline and after 8 weeks
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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 True TECAR Therapy and Traditional Physiotherapy in people with Knee Osteoarthritis, run by Middle East University at 1 site in Egypt.
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 5 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 21 Oct 2026. 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 Egypt. 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?
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?
Balance (time frame: Baseline and after 8 weeks). 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 21 Oct 2026.