NCT07633795

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable knee-osteoarthritis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Visual Analog Scale will be used to assess pain intensity

    Baseline and after 8 weeks

Secondary Outcomes (2)

  • Balance

    Baseline and after 8 weeks

  • Health-Related Quality of Life

    Baseline and after 8 weeks

Study Arms (2)

Study group

ACTIVE COMPARATOR

40 elderly men with knee osteoarthritis who will receive TECAR therapy combined with a traditional physiotherapy program for 8 weeks

Device: True TECAR TherapyOther: Traditional Physiotherapy

Control group

SHAM COMPARATOR

Will include 40 men participating in sham TECAR therapy plus the same traditional physiotherapy program for 8 weeks

Device: Sham TECAROther: Traditional Physiotherapy

Interventions

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

Study group

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.

Control group

Standardized knee osteoarthritis rehabilitation including progressive quad/hamstring strengthening, hip abductor strengthening, range of motion exercises, and flexibility training

Control groupStudy group

Eligibility Criteria

Age65 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males are accepted
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Saher Lotfy Elgayar, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 18, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share