Clinical trial NCT05677399: Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
Official title: The Effectiveness of Peloidotherapy and Aquatic Exercise in Knee Osteoarthritis Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
peloidotherapy
aquatic exercise
water based exercise
balneotherapy
aquatic rehabilitation
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, single blind, prospective, parallel 1:1 group study.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* secondary knee OA
* pathology of the waist, hip, or ankle joints
* decompensated organ failure
* malignancy,
* active bleeding
* infectious disease
* 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.

Primary outcomes:
measure: Pain (VAS)
timeFrame: Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: WOMAC (total)
timeFrame: Change from baseline WOMAC scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
Secondary outcomes:
measure: IGA (VAS)
timeFrame: Change from baseline IGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: PGA (VAS)
timeFrame: Change from baseline PGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: WOMAC (pain)
timeFrame: Change from baseline WOMAC (pain) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: WOMAC (stiffness)
timeFrame: Change from baseline WOMAC (stiffness) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: WOMAC (physical function)
timeFrame: Change from baseline WOMAC (physical function) at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: LAFI
timeFrame: Change from baseline LAFI at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: HAQ
timeFrame: Change from baseline HAQ at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: SF-36
timeFrame: Change from baseline SF-36 at the end of the treatment, 1 month after treatment ,3 months after treatment.
measure: Timed Up and Go Test
timeFrame: Change from baseline TUG at the end of the treatment, 1 month after treatment ,3 months after treatment.
Other outcomes:
Locations:
Study officials:
References: