NCT06418360

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 6, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

knee pain, osteoarthritis, capacitative and resistive energy transfer therap

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    0 min , 10 is maximum pain score

    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."

    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.

    Before and the after treatment 0th day, 1th month, 3rd month

Secondary Outcomes (1)

  • The Diers Myoline Isometric Muscle Strength Measurement System

    Before and the end of treatment 0th day, 1th month, 3rd month

Study Arms (2)

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.

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.

Device: TECAR

Interventions

TECARDEVICE

Transfer Energy Capacitative and Resistive Therapy

conventional physical therapy (CPT) and TECAR therapy

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

conventional physical therapy (CPT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months of conservative treatment for unresponsive knee pain
  • Kellgren-Lawrence grade 2-3 on radiographic evaluation
  • Agreed to participate in the study.

You may not qualify if:

  • 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
  • Diagnosed restless legs syndrome
  • Neoplasia
  • Local sensory impairment,
  • Local or systemic acute infections
  • Severe osteoporosis
  • Pacemaker
  • Psychiatric disorder and cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge TEZEN

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 17, 2024

Study Start

March 13, 2023

Primary Completion

August 23, 2023

Study Completion

November 23, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

participant data will not share

Locations