Comparison of Outpatient and Inpatient Spa Therapy

Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Spa therapy and conventional physical therapy

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Bolu, Merkez, Turkey, 14100
      • Abant Izzet Baysal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Investigators: Principal Investigator: Mustafa Fatih Yaşar, MD, Bolu Abant Izzet Baylsa University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Spa therapy; Electrotherapy; Hotpack
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Physical Med-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No