Clinical trial NCT04192162: Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
Official title: Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of Multiple Joints
Keywords: osteoarthritis
balneotherapy
mud therapy
sulfuric water
serotonin
Lead sponsor: Specialized Rehabilitation Hospital Banja Koviljaca
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Ages of 50 - 65 , both sexes
2. Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
3. Patients who have not changed their medication in the last 2 months
4. Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos...)

Exclusion Criteria:

1. Secondary hip and / or knee OA
2. Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
3. Visible disruption of hip and / or knee joint structures
4. Treatment of malignancy
5. Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding
6. Severe hip and / or knee joint injuries, fractures, and previous surgical procedures
7. Physical therapy, balneotherapy back one year

Primary outcomes:
measure: The serotonin levels
timeFrame: Time Frame: Baseline vs. 12-days
Secondary outcomes:
measure: Marker of inflammation
timeFrame: Time Frame: Baseline vs. 12-days
measure: Analysis of hemoglobin
timeFrame: Time Frame: Baseline vs. 12-days
measure: Analysis of red blood cell counts
timeFrame: Time Frame: Baseline vs. 12-days
Other outcomes:
Locations:
city: Loznica
country: Serbia
facility: Specializd Rehabilitation Hospital Banja Koviljaca
state: Banja Koviljaca
Study officials:
affiliation: Specijalna bolnica za rehabilitaciju Banja Koviljača
name: Aleksandar M Jokić
role: PRINCIPAL_INVESTIGATOR
References: