Knee Osteoarthritis, ObesityNCT01942317
The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis
A study testing Balneotherapy in people with Knee Osteoarthritis, Obesity, run by University of Padova at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Obesity
- What is being tested?
- Balneotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Sep 2015
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obesity II-III grade (BMI 35-45 kg/m2)
- knee pain
- patient compliance to the treatment
Who cannot join
- BMI<34,9kg/m2 or BMI> 45,1kg/m2
- previous knee surgery
- complicated diabetes mellitus
- ischemic cardiomyopathy and heart failure
- acute phase of osteoarthritis
- varicose veins, deep venous thrombosis (DVT)
Show all 10Show fewer
- cancer
- cutaneous lesions
- NSAIDs administration <1 week before the treatment
- knee infiltration <2 months before the treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera-Università degli studi di Padova
Padua, Italy, 35128
Stefano Masiero, +390498211270, stef.masiero@unipd.it
Stefano Masiero
About this study
The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).
- Conditions
- Knee Osteoarthritis, Obesity
- Being tested
- Balneotherapy
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalneotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Balneotherapy | Experimental | 16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks Receives: Other: Balneotherapy |
| Physiotherapy | No intervention | 16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain measurement with Visual Analogue Scale (VAS)
Measured: At the begining and at the end of the treatment. After 6 months of the end of therapy
Secondary outcomes (1)
Knee range of motion
Measured: At the begining and at the end of the treatment. After 6 months of the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis, ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Masiero, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942317
- Sponsor's protocol ID
- 20232
- Other IDs
- 20232, 20232
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01942317
- Acronym / sponsor ID
- 20232
- Conditions
- Knee Osteoarthritis, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- 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 of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy | Experimental | Other: Balneotherapy16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks |
| Physiotherapy | No intervention | –16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obesity II-III grade (BMI 35-45 kg/m2)
- knee pain
- patient compliance to the treatment
Key exclusion criteria (10 listed)
- BMI<34,9kg/m2 or BMI> 45,1kg/m2
- previous knee surgery
- complicated diabetes mellitus
- ischemic cardiomyopathy and heart failure
- acute phase of osteoarthritis
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 |
|---|---|---|
| Balneotherapy | Other | Balneotherapy |
Primary outcome
Knee pain measurement with Visual Analogue Scale (VAS)
Time frame: At the begining and at the end of the treatment. After 6 months of the end of therapy
1 secondary outcome
Knee range of motion
Time frame: At the begining and at the end of the treatment. After 6 months of the end of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balneotherapy in people with Knee Osteoarthritis, Obesity, run by University of Padova at 1 site in Italy.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Sep 2013. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain measurement with Visual Analogue Scale (VAS) (time frame: At the begining and at the end of the treatment. After 6 months of the end of therapy). 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 13 Sep 2013.