Osteoarthritis, KneeNCT04531969
Comparison of Outpatient and Inpatient Spa Therapy
A study testing Spa therapy and conventional physical therapy in people with Osteoarthritis, Knee, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Spa therapy and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with primary knee osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Spa therapy and conventional physical therapy
- Keywords
- Spa therapy, Electrotherapy, Ultrasound, Hotpack
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapy and conventional physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient group | Active comparator | Spa therapy,HP application, deep heater application, and TENS. Receives: Other: Spa therapy and conventional physical therapy |
| Outpatient group | Active comparator | Spa therapy,HP application, deep heater application, and TENS. Receives: Other: Spa therapy and conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start8 Sep 2020
- Primary completion1 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Mustafa Fatih Yaşar, MD, Principal investigator, Bolu Abant Izzet Baylsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531969
- Sponsor's protocol ID
- Physical Med-2
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04531969
- Acronym / sponsor ID
- Physical Med-2
- Conditions
- Osteoarthritis, Knee
- Keywords
- Spa therapy, Electrotherapy, Ultrasound, Hotpack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Inpatient group | Active comparator | Other: Spa therapy and conventional physical therapySpa therapy,HP application, deep heater application, and TENS. |
| Outpatient group | Active comparator | Other: Spa therapy and conventional physical therapySpa therapy,HP application, deep heater application, and TENS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with primary knee osteoarthritis
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapy and conventional physical therapyHP 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. | Other | Inpatient group, Outpatient group |
Primary outcome
Western Ontario and McMaster University (WOMAC) osteoarthritis index
Time frame: 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.
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: two weeks
Timed Up and Go (TUG)
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Fatih Yaşar, MD principal investigator
Bolu Abant Izzet Baylsa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy and conventional physical therapy in people with Osteoarthritis, Knee, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster University (WOMAC) osteoarthritis index (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.