## Protocol Section
### Identification Module
**NCT ID:** NCT04148079

**Brief Title:** Safety of Electrotherapy in Patients With Knee Osteoarthritis and Cardiac Diseases

**Official Title:** Frequency of Arrhythmias During Physiotherapy

#### Organization Study ID Info
**ID:** UniversitateaMFH
#### Organization
**Class:** OTHER
**Full Name:** Universitatea de Medicina si Farmacie Iuliu Hatieganu
### Status Module
#### Completion Date
**Date:** 2017-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-11-04

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-08

**Type:** ACTUAL

#### Start Date
**Date:** 2013-03

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2019-11-01
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-29
**Study First Submit QC Date:** 2019-10-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitatea de Medicina si Farmacie Iuliu Hatieganu

#### Responsible Party

**Investigator Affiliation:** Universitatea de Medicina si Farmacie Iuliu Hatieganu

**Investigator Full Name:** Ciubean Alina Deniza

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. The physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. What is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition.

**Detailed Description:** An analytical and transversal study was carried out between March 2013 and August 2017. The study included a total of 46 patients previously diagnosed with degenerative knee OA. All the patients included in the study were recruited during inpatient visit in the Clinical Rehabilitation Hospital in Cluj-Napoca, Romania.

Each patient was clinically evaluated and was furthermore prescribed a PT program (ET, massage and kinesiotherapy). They were monitored by 24 hour-Holter ECG in 2 separate days, at the beginning of treatment, before applying the PT methods (day 1), and after completing a 10-day PT program (day 2).

PT modalities prescribed for each patient after clinical evaluation included different types of ET, all currently used and included in the national and international treatment guidelines, as in low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy. The program was performed on a daily basis, for 10 days.

The aim of the PT program was to decrease pain and increase range of motion in the affected joints and did not lead to increases in cardiac frequencies. No hydrotherapy was applied, given that that the Holter ECG was not waterproof. No technical incidents were reported during the study. No alternate positioning of the patient wearing a Holter ECG for ET procedures was necessary, as the region of interest was the knee. No change in current drug therapy was allowed for the whole duration of the study.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 46

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy

**Name:** physical therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Minimal, average, maximum heart rate evaluated by 24 hour Holter EKG monitoring

**Measure:** Heart rate

**Time Frame:** Change from Baseline after 10 days

**Description:** supraventricular, ventricular, total extraystoles evaluated by 24 hour Holter EKG monitoring

**Measure:** Supraventricular, ventricular and total Extrasystoles

**Time Frame:** Change from Baseline after 10 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on ACR 2000 diagnostic criteria

Exclusion Criteria:

* known cardiac arrhythmias (atrial fibrillation, atrial flutter)
* congestive heart failure class NYHA II, III or IV
* any other general contraindications for PT (infections, psychiatric disorders etc)

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** 46 patients, 33 female, 13 male 20 patients had a history of arrythmias (e.g.premature atrial contractions) 19 patients had a history of ischemic heart disease

### IPD Sharing Statement Module

**Description:** If asked for the data from someone who needs it, we will be happy to share

**IPD Sharing:** UNDECIDED

## 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: BC14

- Name: Heart and Blood Diseases

- 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: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- 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: 2024-05-24
