Comparison of Outpatient and Inpatient Spa Therapy

Sponsor

Abant Izzet Baysal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04531969

Collaborator

(none)

Enrollment

Location

Arms

27.2

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: Spa therapy and conventional physical therapy	N/A

Detailed Description

Osteoarthritis (OA) has an important place in musculoskeletal diseases and is the most common rheumatic joint disorder characterized by progressive cartilage degeneration. Osteoarthritis of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain, joint stiffness, limited daily activities, and decreased quality of life.

In this study, it was aimed to compare the effects of inpatient and outpatient applications of HP, US, TENS, spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Patients will be aware of group distribution due to the nature of the study. Therefore, the only outcome assessor will be blinded

Primary Purpose:

Treatment

Official Title:

Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis

Actual Study Start Date :

Sep 8, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inpatient group Spa therapy,HP application, deep heater application, and TENS.	Other: Spa therapy and conventional physical therapy HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues. Deep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes. TENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application. Spa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day.
Active Comparator: Outpatient group Spa therapy,HP application, deep heater application, and TENS.	Other: Spa therapy and conventional physical therapy HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues. Deep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes. TENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application. Spa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day.

Arm

Intervention/Treatment

Active Comparator: Inpatient group

Spa therapy,HP application, deep heater application, and TENS.

Other: Spa therapy and conventional physical therapy

HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues. Deep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes. TENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application. Spa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day.

Active Comparator: Outpatient group

Spa therapy,HP application, deep heater application, and TENS.

Other: Spa therapy and conventional physical therapy

Outcome Measures

Primary Outcome Measures

Western Ontario and McMaster University (WOMAC) osteoarthritis index [two weeks]
The form consists of three parts (pain, stiffness, and physical function) and 24 questions. High WOMAC values indicate an increase in pain and stiffness and impairment of physical function.

Secondary Outcome Measures

Visual Analog Scale (VAS) [two weeks]
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).
Timed Up and Go (TUG) [two weeks]
The patient starts in a seated position and stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with primary knee osteoarthritis

Exclusion Criteria:

Patients who have secondary knee osteoarthritis due to various diseases
Patients with pronounced pathology in the waist, hip and ankle joint, patients with active tumors
Patients with febrile infectious disease
Having had serious surgical operations in the last 6 months
Patients who have undergone and/or have been injected with intraarticular steroid and hyaluronic acid into the knee joint
Patients who have received balneotherapy and peloidotherapy in the last one year
Patients with decompensated organ failure, those with inflammatory disease, those with pregnancy and breastfeeding
People with neurological diseases such as epilepsy, inner ear hearing aids, pacemakers and other individuals with a small metallic implant