## Protocol Section
### Identification Module
**NCT ID:** NCT06418360

**Brief Title:** Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis

**Official Title:** Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis

#### Organization Study ID Info
**ID:** E2-23-3792
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2023-11-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-23

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

- Energy Transfer Capacitative and Resistive Therapy

**Keywords:**

- knee pain, osteoarthritis, capacitative and resistive energy transfer therap

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 54

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group 1 (HP, TENS, knee isometric and theraband exercise) to painful side knee area, two weeks, five times a week, 10 sessions.

**Intervention Names:**

- Device: conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack

**Label:** conventional physical therapy (CPT)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: TECAR

**Label:** conventional physical therapy (CPT) and TECAR therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- conventional physical therapy (CPT) and TECAR therapy

**Description:** Transfer Energy Capacitative and Resistive Therapy

**Name:** TECAR

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- conventional physical therapy (CPT)

**Description:** 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

**Name:** conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 0 min , 10 is maximum pain score

**Measure:** Visual Analog Scale (VAS)

**Time Frame:** Before and the after treatment 0th day , 1th month, 3rd month

**Description:** 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."

**Measure:** Western Ontario and McMaster Universities Arthritis Index (WOMAC)

**Time Frame:** Before and the after treatment 0th day, 1th month, 3rd month

**Description:** Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points.

**Measure:** Range of Motion (ROM)

**Time Frame:** Before and the after treatment 0th day, 1th month, 3rd month

#### Secondary Outcomes

**Description:** quadriceps muscle Isometric Strength Measure: Increased isometric muscle strength is an indicator of recovery.

**Measure:** The Diers Myoline Isometric Muscle Strength Measurement System

**Time Frame:** Before and the end of treatment 0th day, 1th month, 3rd month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Özge TEZEN

### IPD Sharing Statement Module

**Description:** participant data will not share

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-31
