Clinical trial NCT06702514: Balneotherapy in Hand Osteoarthritis
Official title: Effectiveness of Balneotherapy in the Treatment of Hand Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are a limited number of studies in the literature on the effectiveness of balneotherapy in hand osteoarthritis. The aim of this study was to evaluate the effects of balneotherapy on pain, manual skills, functionality and quality of life in patients with hand osteoarthritis who have undergone balneotherapy.

Detailed description: Hand osteoarthritis (OA) is a chronic and disabling disease that can cause pain and functional limitations. The estimated radiological prevalence of hand OA is approximately 54-67% in the adult population aged 55 years and older. This prevalence is expected to increase as the number of elderly people increases. Current guidelines strongly recommend exercise as a nonpharmacological approach to the treatment of hand osteoarthritis, while thermal treatments and paraffin therapy are conditionally recommended.

Balneotherapy is defined as a natural mineral water bath and is one of the most widely used nonpharmacological complementary treatments for different rheumatic diseases in many European countries, Turkey, Israel and Japan. In the last decade, related advances have made it possible to understand the therapeutic effects of balneotherapy in some musculoskeletal disorders.

The effectiveness is achieved through a combination of mechanical, thermal and chemical effects. Warm stimuli increase the pain threshold and provide analgesia in nerve endings. The EULAR task force's recommendation for hand OA, which suggests local heat application (e.g. paraffin wax, hot pack) as a useful treatment, also draws attention to the effect of heat. Spa treatment triggers a series of neuroendocrine reactions and particularly induces the release of adrenocorticotropic hormone (ACTH), cortisol, prolactin and growth hormone (GH).

Thermomineral water baths have a small effect on pain, a moderate effect on symptoms related to other musculoskeletal diseases and up to 3 months of pain relief; it is considered to be more beneficial than tap water or no treatment for the improvement of symptoms related to musculoskeletal diseases. Even a single balneotherapy procedure can provide pain relief.

There are a limited number of studies in the literature on the effectiveness of balneotherapy in hand osteoarthritis. The aim of this study was to evaluate the effects of balneotherapy on pain, manual skills, functionality and quality of life in patients with hand osteoarthritis who have undergone balneotherapy.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 50-75
* Hand osteoarthritis diagnosed according to ACR criteria

Exclusion Criteria:

* Non-cooperative patients
* Trauma or surgery to the hand region in the last 6 months
* Infection
* Infection, loss of sensation, metal implant in the treatment area
* Injection to the hand joints in the last 3 months
* Physical therapy and rehabilitation to the hand region in the last 3 months
* Balneotherapy in the last 3 months
* Inflammatory rheumatic diseases
* NSAI use
* Planning pregnancy during pregnancy or treatment
* Malignancy
* Presence of a neurological disease
* Hand-wrist entrapment neuropathy
* Loss of muscle strength or sensation in the hand
* Uncontrolled cardiopulmonary disease
* Open wound
* Orthopedic condition that would prevent entering the spa

Primary outcomes:
measure: Visual Pain Scale (VAS)
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: Palm-to-finger distance
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: The Australian / Canadian Osteoarthritis Hand Index (AUSCAN)
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: Hand Osteoarthritis Functional Index
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: Jamar Dynamometer
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Secondary outcomes:
measure: Nine Hole Pag Test
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: Jebsen Taylor Hand Function Test
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
measure: SF-36 Quality of Life Scale
timeFrame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Other outcomes:
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