Clinical trial NCT04148079: Safety of Electrotherapy in Patients With Knee Osteoarthritis and Cardiac Diseases
Official title: Frequency of Arrhythmias During Physiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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)

Primary outcomes:
measure: Heart rate
timeFrame: Change from Baseline after 10 days
measure: Supraventricular, ventricular and total Extrasystoles
timeFrame: Change from Baseline after 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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