Knee OsteoarthritisNCT05677399
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
A study testing aquatic exercise and peloidotherapy in people with Knee Osteoarthritis, run by Istanbul Arel University.
Trial summary
The aim was to observe the short and medium term effects of peloidotherapy and aquatic exercise applications in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- aquatic exercise and peloidotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2015to 10 Dec 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary knee osteoarthritis diagnosed according to the ACR criteria
- gave their written informed consent
- 40-75 ages
- Kellgren Lawrence grading 2-4
- having symptomatic knee pain at least 3 months.
Who cannot join
- secondary knee OA
- pathology of the waist, hip, or ankle joints
- decompensated organ failure
- malignancy,
- active bleeding
- infectious disease
Show all 9Show fewer
- serious knee injuries or previous surgical procedures within the past 6 months
- the use of intraarticular steroids and hyaluronic acid injection to the knee joint within the past 6 months
- physiotherapy, balneotherapy, or peloidotherapy within the past 1 year.
About this study
Official title: The Effectiveness of Peloidotherapy and Aquatic Exercise in Knee Osteoarthritis Treatment.
The aim was to observe the short and medium term effects of peloidotherapy and aquatic exercise applications in patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is one of the most common musculoskeletal diseases in the world. It is a non-inflammatory chronic disease that starts from the articular cartilage and is characterized by mechanical wear and cartilage loss in the joints, and includes findings such as joint pain, stiffness, and limitation of movement. Its incidence increases with aging. OA is more common in the spine, hip, hand and knee joints. The knee, which is a load-bearing joint, is more affected. Knee osteoarthritis is one of the most common causes of disability. It is more common in women. The prevalence of symptomatic knee osteoarthritis in adults over the age of 55 was found to be 13% In the treatment guidelines, aquatic exercise and balneotherapy are among the recommendations for knee OA. Balneotherapy is a stimulus performed at a certain time interval and in a cure style, by using thermal and/or mineral waters, peloids (medical mud) and gases, in the form of bath, package, drinking and inhalation applications, whose methods and doses have been determined. compliance therapy. There are clinical studies showing that balneotherapy and mud pack applications reduce pain and increase functional capacity in knee osteoarthritis. Odabaşı et al. showed that peloidotherapy, one of the balneological methods, has not only thermic effect but also chemical effect in the treatment of knee OA. In patients with knee OA, pain, physical disability, quadriceps femoris muscle weakness and limitations in joint range of motion are observed. it reduces the level of physical activity, exercise capacity and quality of life in these people. The fact that the body is supported due to the buoyancy of the water in the exercises performed in the water reduces the load on the joints during the movement. For this reason, many movements that cannot be done on land can be done safely in water. On the other hand, because the density of water is higher than air, the muscles have to do more work even when performing a simple movement in water compared to the movements on land. Special rehabilitation programs based on water exercise programs have started to be one of the applications that can be done to increase muscle strength for these reasons.
When the literature was reviewed, we could not find any study examining the combination of aquatic exercise and peloid application in patients with knee osteoarthritis.
The aim of this study was to evaluate the effects of co-administration of peloid and aquatic exercises in knee osteoarthritis patients with a single-blind randomized controlled study.
- Conditions
- Knee Osteoarthritis
- Being tested
- aquatic exercise and peloidotherapy
- Keywords
- knee osteoarthritis, peloidotherapy, aquatic exercise, water based exercise, balneotherapy, aquatic rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic exercise and peloidotherapyOther
Also called water based exercise and mud pack therapy
Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions). Receives: Other: aquatic exercise and peloidotherapy |
| Control Group | No intervention | Control group continued to use their usual medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.
Measured: Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (total)
The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC
Measured: Change from baseline WOMAC scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
Secondary outcomes (9)
IGA (VAS)
Investivagors' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
Measured: Change from baseline IGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
PGA (VAS)
Patients' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
Measured: Change from baseline PGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (pain)
The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
Measured: Change from baseline WOMAC (pain) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (stiffness)
The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
Measured: Change from baseline WOMAC (stiffness) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (physical function)
The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
Measured: Change from baseline WOMAC (physical function) at the end of the treatment, 1 month after treatment ,3 months after treatment.
LAFI
LAFI is used to determine the pain and functional severity of knee and hip OA with three parts of pain, maximum walk distance and some activities of daily living. It has 11 questions of total score of 0 to 24 that higher scores shows more involvement
Measured: Change from baseline LAFI at the end of the treatment, 1 month after treatment ,3 months after treatment.
HAQ
HAQ is used to evaluate functional disability status of patients in eight subscales; dressing, rising, eating, walking, hygiene, reach, grip and usual activities. It includes 20 items and each item has 3 likert score which 0 to 3 where 3 is unable to do
Measured: Change from baseline HAQ at the end of the treatment, 1 month after treatment ,3 months after treatment.
SF-36
The SF-36 Health Survey is a comprehensive measurement tool used to evaluate non-disease-specific overall quality of life. It has been developed and made available by Rand Corporation in order to evaluate overall quality of life (). It contains a total of 36 items with eight subscales: physical functioning, role-physical, role-emotional, bodily pain, social functioning, mental health, vitality, and general health. It grades the patient by using scores between 0 and 100,0 indicating poor health while 100 indicating good health. Turkish validity and reliability study had been con¬ducted for SF-36
Measured: Change from baseline SF-36 at the end of the treatment, 1 month after treatment ,3 months after treatment.
Timed Up and Go Test
TUG is a valid and reliable functional mobility test. It has a correlation with lower extremity strength and useful for identifying older adults risk of falling
Measured: Change from baseline TUG at the end of the treatment, 1 month after treatment ,3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start9 Sep 2015
- Primary completion10 Jun 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- A Randomized, single blind, prospective, parallel 1:1 group study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil ÖZKURT, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677399
- Sponsor's protocol ID
- 5000007
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Peloidotherapy and Aquatic Exercise in Knee Osteoarthritis Treatment.
- ClinicalTrials.gov ID
- NCT05677399
- Acronym / sponsor ID
- 5000007
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, peloidotherapy, aquatic exercise, water based exercise, balneotherapy, aquatic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 10 Jan 2023 (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.
The aim was to observe the short and medium term effects of peloidotherapy and aquatic exercise applications in patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is one of the most common musculoskeletal diseases in the world. It is a non-inflammatory chronic disease that starts from the articular cartilage and is characterized by mechanical wear and cartilage loss in the joints, and includes findings such as joint pain, stiffness, and limitation of movement. Its incidence increases with aging. OA is more common in the spine, hip, hand and knee joints. The knee, which is a load-bearing joint, is more affected. Knee osteoarthritis is one of the most common causes of disability. It is more common in women. The prevalence of symptomatic knee osteoarthritis in adults over the age of 55 was found to be 13% In the treatment guidelines, aquatic exercise and balneotherapy are among the recommendations for knee OA. Balneotherapy is a stimulus performed at a certain time interval and in a cure style, by using thermal and/or mineral waters, peloids (medical mud) and gases, in the form of bath, package, drinking and inhalation applications, whose methods and doses have been determined. compliance therapy. There are clinical studies showing that balneotherapy and mud pack applications reduce pain and increase functional capacity in knee osteoarthritis. Odabaşı et al. showed that peloidotherapy, one of the balneological methods, has not only thermic effect but also chemical effect in the treatment of knee OA. In patients with knee OA, pain, physical disability, quadriceps femoris muscle weakness and limitations in joint range of motion are observed. it reduces the level of physical activity, exercise capacity and quality of life in these people. The fact that the body is supported due to the buoyancy of the water in the exercises performed in the water reduces the load on the joints during the movement. For this reason, many movements that cannot be done on land can be done safely in water. On the other hand, because the density of water is higher than air, the muscles have to do more work even when performing a simple movement in water compared to the movements on land. Special rehabilitation programs based on water exercise programs have started to be one of the applications that can be done to increase muscle strength for these reasons.
When the literature was reviewed, we could not find any study examining the combination of aquatic exercise and peloid application in patients with knee osteoarthritis.
The aim of this study was to evaluate the effects of co-administration of peloid and aquatic exercises in knee osteoarthritis patients with a single-blind randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, single blind, prospective, parallel 1:1 group study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: aquatic exercise and peloidotherapyTreatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions). |
| Control Group | No intervention | –Control group continued to use their usual medical treatment. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary knee osteoarthritis diagnosed according to the ACR criteria
- gave their written informed consent
- 40-75 ages
- Kellgren Lawrence grading 2-4
- having symptomatic knee pain at least 3 months.
Key exclusion criteria (9 listed)
- secondary knee OA
- pathology of the waist, hip, or ankle joints
- decompensated organ failure
- malignancy,
- active bleeding
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 |
|---|---|---|
| aquatic exercise and peloidotherapyAlso: water based exercise and mud pack therapyTreatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions). | Other | Treatment Group |
Primary outcome
Pain (VAS)
Time frame: Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.
WOMAC (total)
Time frame: Change from baseline WOMAC scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC
9 secondary outcomes
IGA (VAS)
Time frame: Change from baseline IGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
PGA (VAS)
Time frame: Change from baseline PGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (pain)
Time frame: Change from baseline WOMAC (pain) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (stiffness)
Time frame: Change from baseline WOMAC (stiffness) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
WOMAC (physical function)
Time frame: Change from baseline WOMAC (physical function) at the end of the treatment, 1 month after treatment ,3 months after treatment.
LAFI
Time frame: Change from baseline LAFI at the end of the treatment, 1 month after treatment ,3 months after treatment.
HAQ
Time frame: Change from baseline HAQ at the end of the treatment, 1 month after treatment ,3 months after treatment.
SF-36
Time frame: Change from baseline SF-36 at the end of the treatment, 1 month after treatment ,3 months after treatment.
Timed Up and Go Test
Time frame: Change from baseline TUG at the end of the treatment, 1 month after treatment ,3 months after treatment.
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 10 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic exercise and peloidotherapy in people with Knee Osteoarthritis, run by Istanbul Arel University.
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 5 inclusion and 9 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (VAS) (time frame: Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.). The study lists 2 primary outcomes in all. 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 10 Jan 2023.