Comparison of Outpatient and Inpatient Spa Therapy

Osteoarthritis, Knee Clinical Trial

Official title:

Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531969
• Other study ID #: Physical Med-2
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: September 2023
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 15, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two weeks
Secondary	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).	two weeks
Secondary	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.	two weeks