Comparison of Outpatient and Inpatient Spa Therapy

NCT04531969 | Completed DMC

• 1 other identifier: Physical Med-2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Spa therapy; Electrotherapy; Ultrasound; Hotpack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Scale (VAS)

  two weeks

• Timed Up and Go (TUG)

  two weeks

Study Arms (2)

Inpatient group

ACTIVE COMPARATOR

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

Other: Spa therapy and conventional physical therapy

Outpatient group

ACTIVE COMPARATOR

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

Other: Spa therapy and conventional physical therapy

Interventions

Spa therapy and conventional physical therapy OTHER

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.

Inpatient group; Outpatient group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with primary knee osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mustafa Fatih Yaşar, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be aware of group distribution due to the nature of the study. Therefore, the only outcome assessor will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: September 8, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2022
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)