Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis

NCT07633795 — Not applicable, Completed, 80 participants, Middle East University

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Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis: A Randomized Controlled Trial

RegistryNCT07633795
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Actual)
SponsorMiddle East University (Other)
ConditionsKnee Osteoarthritis
InterventionsTrue TECAR Therapy, Sham TECAR, Traditional Physiotherapy (Device, other)
Datesstart 2026-06-15, primary completion 2026-10-12, completion 2026-10-16, first posted 2026-06-08, last updated 2026-10-21
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Knee Osteoarthritis All trials of True TECAR Therapy All trials of Sham TECAR

-Summary

Evaluate the effect of TECAR therapy combined with traditional physiotherapy on pain, balance, and quality of life in elderly men with knee osteoarthritis .

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TECAR groupActive comparatorDevice: 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 groupSham comparatorDevice: Sham TECAR; Other: Traditional PhysiotherapyWill include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks
  • True TECAR Therapy (Device): 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 TECAR (Device): 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 Physiotherapy (Other): Standardized knee osteoarthritis rehabilitation including progressive quad/hamstring strengthening, hip abductor strengthening, range of motion exercises, and flexibility training

+Outcome measures

Primary outcomes

  • Balance [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).

Secondary outcomes

  • Pain Intensity [Baseline and after 8 weeks]: 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.
  • Health-Related Quality of Life [Baseline and after 8 weeks]: 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).
  • Quadriceps Isokinetic Strength [Baseline and after 8 weeks]: 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.
  • Isokinetic Knee Flexion / Extension Range of Motion [Baseline and after 8 weeks]: Will be assessed using an isokinetic dynamometer which simultaneously tracks joint range of motion (in degrees) via built-in optical encoders.

+Eligibility

Sex: Male, ages: 65 Years to 75 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

+Locations (1)

FacilityCityCountryStatus
Elmahalla General HospitalTantaEgypt