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Comparison of Outpatient and Inpatient Spa Therapy

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Spa therapy and conventional physical therapy

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Spa therapy, Electrotherapy, Ultrasound, Hotpack

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Inpatient group

Outpatient group

Arm Description

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

Outcomes

Primary Outcome Measures

Western Ontario and McMaster University (WOMAC) osteoarthritis index

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)

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)

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.

Full Information

NCT ID

NCT04531969

First Posted

August 26, 2020

Last Updated

September 22, 2023

Sponsor

Abant Izzet Baysal University

1. Study Identification

Unique Protocol Identification Number

NCT04531969

Brief Title

Comparison of Outpatient and Inpatient Spa Therapy

Official Title

Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Spa therapy, Electrotherapy, Ultrasound, Hotpack

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

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

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inpatient group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Outpatient group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Spa therapy and conventional physical therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Western Ontario and McMaster University (WOMAC) osteoarthritis index

Description

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.

Time Frame

two weeks

Secondary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

Time Frame

two weeks

Title

Timed Up and Go (TUG)

Description

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa Fatih Yaşar, MD

Organizational Affiliation

Bolu Abant Izzet Baylsa University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abant Izzet Baysal University

City

Bolu

State/Province

Merkez

ZIP/Postal Code

14100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Outpatient and Inpatient Spa Therapy

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