Osteoarthritis of Multiple JointsNCT04192162
Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
A study testing Mud therapy application, Sulfur water application and Hygienic water in people with Osteoarthritis of Multiple Joints, run by Specialized Rehabilitation Hospital Banja Koviljaca at 1 site in Serbia.
Trial summary
This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthritis of Multiple Joints
- What is being tested?
- Mud therapy application, Sulfur water application and Hygienic water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 18 Dec 2019to 1 Sep 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 50 - 65 , both sexes
- Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
- Patients who have not changed their medication in the last 2 months
- Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos…)
Who cannot join
- Secondary hip and / or knee OA
- Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
- Visible disruption of hip and / or knee joint structures
- Treatment of malignancy
- Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding
- Severe hip and / or knee joint injuries, fractures, and previous surgical procedures
- Physical therapy, balneotherapy back one year
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Specializd Rehabilitation Hospital Banja Koviljaca
Loznica, Banja Koviljaca, 15316
Aleksandar M Jokić, +381648731317, jokic71@gmail.com
About this study
This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.
Read the detailed description
Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression.
The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive.
Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.
This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.
- Conditions
- Osteoarthritis of Multiple Joints
- Being tested
- Mud therapy application, Sulfur water application, Hygienic water
- Keywords
- osteoarthritis, balneotherapy, mud therapy, sulfuric water, serotonin
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mud therapy applicationOther
Also called mud pack
Aplication the mud pack therapy from 20 minutes
Sulfur water applicationOther
Also called Sulfur bath
Aplication the sulfur water in bath from 20 minutes
Hygienic waterOther
Also called Exercise in hygienic water
Exercise in hygienic water
| Study group | Role | What they receive |
|---|---|---|
| Group of sulfur balneotherapy and mud pack therapy | Experimental | Experimental group patients underwent sulfur balneotherapy and mud pack therapy. The duration of spa therapy program was 12 days.From the blood of patients, serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy. Receives: Other: Mud therapy application; Other: Sulfur water application |
| Group of sulfur balneotherapy, mud pack therapy and exercise | Active comparator | Control group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy. Receives: Other: Mud therapy application; Other: Sulfur water application; Other: Hygienic water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serotonin levels
Serotonin concentration
Measured: Time Frame: Baseline vs. 12-days
Secondary outcomes (3)
Marker of inflammation
Sedimentation concentration
Measured: Time Frame: Baseline vs. 12-days
Analysis of hemoglobin
Concentration of hemoglobin (g/L)
Measured: Time Frame: Baseline vs. 12-days
Analysis of red blood cell counts
The total number of erythrocytes / L
Measured: Time Frame: Baseline vs. 12-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start18 Dec 2019
- Primary completion18 Apr 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Multiple JointsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Specialized Rehabilitation Hospital Banja Koviljaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandar M Jokić, Principal investigator, Specijalna bolnica za rehabilitaciju Banja Koviljača
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192162
- Sponsor's protocol ID
- SRH BanjaKoviljaca
- Status last verified
- Dec 2019
- First submitted
- 12 Nov 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
- ClinicalTrials.gov ID
- NCT04192162
- Acronym / sponsor ID
- SRH BanjaKoviljaca
- Conditions
- Osteoarthritis of Multiple Joints
- Keywords
- osteoarthritis, balneotherapy, mud therapy, sulfuric water, serotonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Specialized Rehabilitation Hospital Banja KoviljacaUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 18 Apr 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.
Detailed description
Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression.
The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive.
Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.
This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of sulfur balneotherapy and mud pack therapy | Experimental | Other: Mud therapy application, Other: Sulfur water applicationExperimental group patients underwent sulfur balneotherapy and mud pack therapy. The duration of spa therapy program was 12 days.From the blood of patients, serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy. |
| Group of sulfur balneotherapy, mud pack therapy and exercise | Active comparator | Other: Mud therapy application, Other: Sulfur water application, Other: Hygienic waterControl group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages of 50 - 65 , both sexes
- Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
- Patients who have not changed their medication in the last 2 months
- Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos…)
Key exclusion criteria (7 listed)
- Secondary hip and / or knee OA
- Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
- Visible disruption of hip and / or knee joint structures
- Treatment of malignancy
- Diseases of the heart, lungs, decompensated conditions of other organs, infections, 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 |
|---|---|---|
| Mud therapy applicationAlso: mud packAplication the mud pack therapy from 20 minutes | Other | Group of sulfur balneotherapy and mud pack therapy, Group of sulfur balneotherapy, mud pack therapy and exercise |
| Sulfur water applicationAlso: Sulfur bathAplication the sulfur water in bath from 20 minutes | Other | Group of sulfur balneotherapy and mud pack therapy, Group of sulfur balneotherapy, mud pack therapy and exercise |
| Hygienic waterAlso: Exercise in hygienic waterExercise in hygienic water | Other | Group of sulfur balneotherapy, mud pack therapy and exercise |
Primary outcome
The serotonin levels
Time frame: Time Frame: Baseline vs. 12-days
Serotonin concentration
3 secondary outcomes
Marker of inflammation
Time frame: Time Frame: Baseline vs. 12-days
Analysis of hemoglobin
Time frame: Time Frame: Baseline vs. 12-days
Analysis of red blood cell counts
Time frame: Time Frame: Baseline vs. 12-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- 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.
Aleksandar M Jokić principal investigator
Specijalna bolnica za rehabilitaciju Banja Koviljača
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mud therapy application, Sulfur water application and Hygienic water in people with Osteoarthritis of Multiple Joints, run by Specialized Rehabilitation Hospital Banja Koviljaca at 1 site in Serbia.
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 4 inclusion and 7 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 20 Dec 2019. 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 Serbia. 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?
Contact Aleksandar M Jokić (+381648731317, jokic71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The serotonin levels (time frame: Time Frame: Baseline vs. 12-days). 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 20 Dec 2019.